Regulatory Technology Services (RTS) is the #1 FDA Accredited Third Party 510k Review Organization to perform 510(k) reviews under the FDA’s Accredited Persons Program (3P510k).
Since our inception, RTS engineers, scientists, and clinicians have reviewed over 1,500 submissions averaging 10-14 days from receipt of submission to completion of substantive review.
RTS is the leading and longest serving FDA Accredited 3P510k Review Organization reviewing over 70% of all reviews completed by Third Party Organizations, year after year. In business since 2003, RTS has reviewed and cleared over 1,500 510(k) submissions. RTS has a highly qualified team of reviewers with the scientific, technical and regulatory expertise to review a broad range of Class I and Class II medical devices. RTS is also the only FDA Accredited 3P510k Review Organization that has the eligibility to review medical devices in all twenty of the Medical Specialties / Review Panels listed on the FDA List of Devices for 3P510k Third Party Review (go.usa.gov/xVUX7).
One of the key drivers cited by the FDA for creating the FDA 3P510k Accredited Persons Program is "enhanced speed to market" and no organization embraces this ideal better than RTS. Our unparalleled speed and experience assures you the fastest turnaround time for your eligible 510(k) product review and clearance. We are routinely months faster reviewing and clearing 510(k) submissions versus the FDA, with administrative review completed in 24 hours and substantive review completed in 10-14 days.
3M Company, Unitek Orthodontic Products | 3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex)
Device Classification Name: aligner, sequential
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231464
Mectron S.p.A. | Combi Touch
Device Classification Name: scaler, ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231391
Philips Ultrasound LLC | EPIQ Series Diagnostic Ultrasound System
Device Classification Name: system, imaging, pulsed doppler, ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231190
3M ESPE Dental Products | 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment
Device Classification Name: varnish, cavity
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231338
TriSalus Life Sciences | TriSalus TriNav® LV Infusion System
Device Classification Name: catheter, continuous flush
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230957
Chongqing Rob Linka Science And Technology Co., Ltd. | TENS7000 Rechargeable (Model:TENS7000 Rechargeable)
Device Classification Name: stimulator, nerve, transcutaneous, over-the-counter
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230829
Alliage S/A Industrias Medica Odontológico. | Eagle S/Saevo Slim/D700 Slim
Device Classification Name: system, x-ray, extraoral source, digital
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230732
Sprig Oral Health Technologies, Inc. | SmartMTA Capsule
Device Classification Name: resin, root canal filling
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230797
CyMedica Orthopedics, Inc. | Motive™ Electrode
Device Classification Name: electrode, cutaneous
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230533
Siemens Healthcare GmBH | Syngo Carbon Space VA30A
Device Classification Name: system, image processing, radiological
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230561
ALG Health LLC | Savvy Surgical Mask - Level 3
Device Classification Name: mask, surgical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230383
Siemens Medical Solutions USA, Inc. | ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound System
Device Classification Name: system, imaging, pulsed doppler, ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230207
Siemens Healthcare GmBH | syngo.via View&GO VA40A
Device Classification Name: system, image processing, radiological
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230196
Nephron Pharmaceuticals Corporation | Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs)
Device Classification Name: polymer patient examination glove
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223559
Philips Ultrasound LLC | PercuNav Image Fusion and Interventional Navigation System
Device Classification Name: system, x-ray, tomography, computed
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223804
3M ESPE Dental Products | 3M™ VitCal Liner/Base
Device Classification Name: liner, cavity, calcium hydroxide
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230270
Atomica Technology, Inc. | Atomica Planner
Device Classification Name: system, image processing, radiological
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230012
Qingdao Yasee Medical Device Co., Ltd. | Electronic Sphygmomanometers
Device Classification Name: system, measurement, blood-pressure, non-invasive
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222394
Mima-Pro Scientific Inc. | SurBlate Ablation System
Device Classification Name: system, ablation, microwave and accessories
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223272
US Medical Glove Company LLC | Nitrile Exam Gloves (Chemotherapy Drug Tested)
Device Classification Name: polymer patient examination glove
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223748
TECHFIT Digital Surgery Inc. | TECHFIT Diagnostic Models
Device Classification Name: system, image processing, radiological
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222577
Solta Medical, Inc. | CLEAR+BRILLIANT TOUCH® Laser System
Device Classification Name: powered laser surgical instrument
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223647
Fuji Systems Corporation | CELLO II Balloon Guide Catheter
Device Classification Name: catheter, percutaneous, neurovasculature
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223275
Premier Dental Products Company | Premier's MultiMatch Universal Chameleon Restorative Composite
Device Classification Name: material, tooth shade, resin
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223632
phenox Ltd | pNOVUS 21 Microcatheter
Device Classification Name: catheter, intravascular, diagnostic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221279
America’s Supply Chains | High Fluid-Resistant Surgical and Procedure Mask
Device Classification Name: mask, surgical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222749
SafeSource Direct, LLC | SafeSource Direct Blue Powder-Free Nitrile Exam Gloves
Device Classification Name: polymer patient examination glove
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222898
Aquilo Sports LLC | Aquilo Sports CCT1500 System
Device Classification Name: massager, powered inflatable tube
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223164
America's Supply Chains | POSE™ Health Care Surgical Mask
Device Classification Name: mask, surgical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223270
Philips Ultrasound LLC | 5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W)
Device Classification Name: system, imaging, pulsed doppler, ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222648
DETAX GmbH | FREEPRINT crown
Device Classification Name: material, tooth shade, resin
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222877
Lamidey Noury Medical | MCB UNIT Model: V10GMCBUS
Device Classification Name: unit, electrosurgical, endoscopic (with or without accessories)
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222542
LightForce Orthodontics | LightForce Orthodontic System
Device Classification Name: bracket, ceramic, orthodontic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222764
Shanghai Kindly Medical Instruments Co., Ltd | INT Introducer Set
Device Classification Name: introducer, catheter
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222647
Qingdao Yasee Medical Device Co., Ltd.
|
Infrared Forehead Thermometer
thermometer, electronic, clinical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220084
Phu Bao Group Company Limited
|
Perfetta Moderate Medical Face Mask
mask, surgical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222426
Invivo Corporation (Business Trade Name: Philips)
|
8ch Wrist Coil
coil, magnetic resonance, specialty
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222325
Invivo Corporation (Business Trade Name: Philips)
|
1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil
coil, magnetic resonance, specialty
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222257
Huachenyang (Shenzhen) Technology Co. Ltd.
|
iClean Viral Transport System (VTM-RT kit)
culture media, non-propagating transport
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212856
DenMat Holding, LLC
|
DenMat Glutaraldehyde Desensitizer
agent, tooth bonding, resin
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222357
LimFlow Inc.
|
LimFlow V-Ceiver
device, percutaneous retrieval
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222083
Bodyport Inc.
|
Bodyport Cardiac Scale
plethysmograph, impedance
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211585
GoodGloves Industries Sdn Bhd
|
Powder-Free Nitrile Examination Glove, Non-Sterile
polymer patient examination glove
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221877
NormaTec Industries, LP
|
Normatec Go
massager, powered inflatable tube
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221666
Inari Medical
|
Artix Ballon Guiding Sheath
catheter, percutaneous
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221846
Medi USA, L.P.
|
medi pneumatic compression system (pcs)-genius (Model 652)
sleeve, limb, compressible
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221654
Axial Medical Printing Limited
|
Axial3D Cloud Segmentation Service
system, image processing, radiological
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221511
Siemens Medical Solutions USA, Inc
|
ACUSON Sequoia Diagnostic Ultrasound System
system, imaging, pulsed doppler, ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221500
3M Company ESPE Dental Products
|
3M Filtek Supreme Flowable Restorative
material, tooth shade, resin
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221695
Whill, Inc.
|
WHILL Model F
wheelchair, powered
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221438
Bard Peripheral Vascular, Inc
|
Liverty™ TIPS Access Set
introducer, catheter
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221440
Siemens Medical Solutions USA, Inc.
|
syngo Dynamics (Version VA40E)
system, image processing, radiological
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220832
SafeSource Direct, LLC
|
Procedure Mask with Ear Loops and Surgical Mask with Ties
mask, surgical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221134
Acutus Medical, Inc.
|
AcQGuide® VUE Steerable Sheath
catheter, steerable
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221044
Strados Labs, Inc.
|
Strados Remote Electronic Stethoscope Platform (RESP)
Recorder, Magnetic Tape, Medical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220893
BB Imaging
|
TeleScan
System, Image Processing, Radiological
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220767
ImaCor Inc
|
ImaCor Zura Handheld ZHH-010
System, Imaging, Pulsed Doppler, Ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220490
KDI Med Supply
|
3 Ply Medical Grade Single Use Procedural Disposable Face Mask
Mask, Surgical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220637
Erchonia Corporation
|
Erchonia Zerona Z-Bed
Fat Reducing Low Level Laser
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220519
StratoScientific |
Steth IO Spot
Stethoscope, Electronic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220196
K Line Europe GmbH
|
K Clear
Aligner, Sequential
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220726
NormaTec Industries, LP
|
Normatec 3
Massager, Powered Inflatable Tube
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220217
Megine Industries Sdn Bhd
|
Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange
Polymer Patient Examination Glove
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220232
GE Healthcare Information Technologies, Inc.
|
Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX
Computer, Diagnostic, Programmable
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213972
Hong Qiangxing (Shen Zhen) Electronics Limited
|
TENS & PMS (Model: SM9126)
Stimulator, Nerve, Transcutaneous, Over-The-Counter
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220150
Acutus Medical, Inc.
|
AcQCross Qx Integrated Transseptal Dilator/Needle
Introducer, Catheter
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220047
OXOS Medical, Inc.
|
Micro C Medical Imaging System, M01
System, X-Ray, Mobile
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212654
Elastic Care Incorporated
|
LifePath Remote Patient Monitoring Platform
Transmitters And Receivers, Physiological Signal, Radiofrequency
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211822
3M Deutschland GmbH
|
Permadyne
Material, Impression
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220257
Traverse Vascular, Inc.
|
QuikPass Catheter
Catheter, Percutaneous
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K214106
Danameco Medical Joint Stock Corporation
|
D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply
Mask, Surgical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213970
Xinxiang Kangbeier Medical Technology Co., Ltd.
|
Kangbeier Surgical Mask (Model: KBR-1001)
Mask, Surgical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213920
Stronghold Group LLC
|
Stronghold Group Nitrile Examination Glove, Powder Free
Polymer Patient Examination Glove
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213859
FUJIFILM Sonosite, Inc.
|
Sonosite PX Ultrasound System
System, Imaging, Pulsed Doppler, Ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213763
Invivo Corporation
|
DS FootAnkle 16Ch Coils For 1.5T And 3.0T, DS HiRes HandWrist 16Ch Coils For 1.5T And 3.0T, Ds Small Extremity 16Ch Coils For 1.5T And 3.0T
Coil, Magnetic Resonance, Specialty
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213766
Cirdan Imaging Ltd
|
Solas OR
Cabinet, X-Ray System
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213691
Bedfont Scientific Ltd
|
ICOquit® Smokerlyzer®
Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211918
UltiMed Incorporated
|
UltiCare Disposable Pen Needles
Needle, Hypodermic, Single Lumen
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213407
Texas MedPlast LLC
|
Savvy Mask - Level 3 Surgical Face Mask
Mask, Surgical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213406
Whill, Inc.
|
WHILL Model C2
Wheelchair, Powered
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213383
Invivo Corporation (Business Trade Name: Philips) |
Ds Head 32ch 3.0T
Coil, Magnetic Resonance, Specialty
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213351
Titan Manufacturing, Inc. |
Titan Manufacturing Bipolar Forceps
Electrosurgical, Cutting & Coagulation & Accessories
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213386
Philips Medizin Systeme Boeblingen GmbH
|
Philips IntelliVue GuardianSoftware (Rev. E.0X)
Display, Cathode-Ray Tube, Medical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212208
Zhuhai DR Medical Instruments Co., Ltd |
DR Safety Syringe, Sterile Hypodermic Needle For Single Use
Syringe, Antistick
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212226
Philips Medical Systems
|
Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System
System, Imaging, Pulsed Doppler, Ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212704
Biotech Dental Smilers, SAS
|
SMILERS
Aligner, Sequential
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212961
ReMade USA LLC |
Surgical Mask
Mask, Surgical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212451
Diode Art Engineering Doing Business As Air Relax |
Air Relax Pro Model AR-4.0
Massager, Powered Inflatable Tube
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212491
Pulmonx Corporation |
Lung Image Analysis
System, X-Ray, Tomography, Computed
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212494
Deerfield Imaging, Inc. |
IMRIS IMRI 3T V
System, Nuclear Magnetic Resonance Imaging
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212367
EchoNous, Inc.
|
Kosmos
System, Imaging, Pulsed Doppler, Ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212100
Invivo Corporation
|
DynaCAD
System, Image Processing, Radiological
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212175
Mid-America Safety Corp. | MASC Surgical Mask
Mask, Surgical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211984
Athlos Oy | DC-Air And Athlos-1 And Athlos-Air
System, X-Ray, Extraoral Source, Digital
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211688
Siemens Medical Solutions USA, Inc | ACUSON Sequoia Diagnostic Ultrasound System
System, Imaging, Pulsed Doppler, Ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211859
SpinTech, Inc. | STAGE
System, Nuclear Magnetic Resonance Imaging
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210843
JointVue LLC | 3d Echo V1.1
System, Image Processing, Radiological
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211656
Crystalline Medical | Vu-Path Ultrasound System
System, Imaging, Pulsed Doppler, Ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203657
Megine Industries Sdn Bhd | AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange)
Polymer Patient Examination Glove
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211310
PremiumEStore, LLC | Amerishield Surgical Mask
Mask, Surgical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211520
OXOS Medical, Inc. | Micro C Medical Imaging System, M01
System, X-Ray, Mobile
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211473
American Surgical Mask Company LLC | ASM-301 Level 3 Surgical Mask
Mask, Surgical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211440
Bistos Co., Ltd. | Infant Phototherapy Equipment
Unit, Neonatal Phototherapy
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210289
MetriTrack, Inc. | Breast Volume Navigator (BVN) Model G-2000
System, Imaging, Pulsed Echo, Ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211098
Diode Art Engineering Doing Business As Air Relax | Air Relax Plus Model AR-3.0
Massager, Powered Inflatable Tube
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211460
PremiumEStore, LLC | AirMax Procedure Mask
Mask, Surgical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211275
CGX, LLC | Quick-20m
Amplifier, Physiological Signal
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203331
Acutus Medical, Inc. | Acqguide Max Steerable Sheath
Catheter, Steerable
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211100
Gilero, LLC | SmartSite Bag 500mL, SmartSite Bag 250 ML, SmartSite Bag 100 ML
Container, I.V.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201936
Scientia Vascular LLC | Plato 17 Microcatheter
Catheter, Percutaneous
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210601
3M Company | 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)
Aligner, Sequential
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211190
Introducer, Catheter
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210685
Imaging, Pulsed Doppler, Ultrasonic System
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210743
Surgical Mask
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K202708
Caries Detection Device
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200601
Surgical Mask
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210487
Surgical Mask
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210225
Surgical Mask
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210063
Stimulator, Muscle, Powered, For Muscle Conditioning
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210174
Surgical Mask
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203425
Surgical Mask
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K202214
Percutaneous Catheter
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203275
Surgical Mask
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203265
Cardiovascular Surgical Vascular Clamp
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203803
Orthopedic Diagnostic Arthroscope
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203526
Mobile X-Ray System
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203658
Powered Inflatable Tube Massager, Physical Medicine Therapy
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203552
PACS
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203249
Image-intensified Fluoroscopic X-Ray System
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203087
Computed Tomography X-Ray System
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203216
PACS
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203058
Intravascular Administration Set, General Hospital and Personal Use Therapy
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200425
Vaginal Stent, Obstetrical and Gynecological Prosthetic Device
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K202542
Stationary X-Ray System
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K202564
Gastroenterology Urology Catheter and Accessories
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K202566
Orthodontic Plastic Bracket, Dental Therapy
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K202685
Ultrasonic Pulsed Doppler Imaging System
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K202406
Ultrasonic Pulsed Doppler Imaging System
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K202216
Self-Retaining Retractor For Neurosurgery
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K202072
Biopsy Instrument, Gastroenterology Urology
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K202012
Orthodontic Plastic Bracket
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K193130
Percutaneous Cardiovascular Catheter
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201076
Stethoscope, Cardiovascular Diagnostic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201299
Ultrasonic Pulsed Doppler Imaging System
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201633
Dental Prosthetic Tooth Shade Resin
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201668
Ultrasonic Pulsed Doppler Imaging System
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201130
Computed Tomography X-Ray System
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201053
Ultrasonic Pulsed Doppler Imaging System
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200964
Neurovascular Percutaneous Catheter
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200910
Magnetic Resonance Diagnostic Device
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200327
Anesthesia conduction catheter, percutaneous introducer
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200624
Ultrasonic Pulsed Doppler Imaging System
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200707
Prefilled Syringe
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200556
Cardiovascular Monitoring Blood Flowmeter
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200337
Drug Dose Calculator
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200443
Ultrasonic Pulsed Doppler Imaging System
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200304
Orthodontic Plastic Bracket
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200214
Orthodontic Plastic Bracket
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200148
General and Plastic Surgery Laparoscope
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200228
PACS
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200179
The list above is not all-inclusive. All devices reviewed by RTS are listed on the FDA website.