RTS is a Third Party Review Organization accredited to perform 510(k) reviews under the FDA’s Accredited Persons Program.

RTS engineers, scientists, and clinicians have reviewed over 1,500 submissions in 18 years, averaging 10-14 days from receipt of submission to completion of initial review.


Recent Clearances - Updated as of July 30, 2022


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 is not all-inclusive. All devices reviewed by RTS are listed on the FDA website.

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