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.

Recent Clearances - Updated as of December 9, 2022


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.

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