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510(k) Device Clearances

Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.

15,000 total clearances

Ultrasonic Gastrovideoscope

Sonoscape Medical Corp.

SnapshotNIR model KD205

Kent Imaging, Inc.

RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Revers

Gyrus Acmi, Inc.

BTL-899A

BTL Industries, Inc.

Vessel Sealer Curved (480522)

Intuitive Surgical, Inc.

Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1)

Surgify Medical OY

CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)

Shenzhen Kaiyan Medical Equipment Co., Ltd.

Elos Accurate® Hybrid Base™

Elos Medtech Pinol A/S

APTUS Foot System 2.8-3.5

Medartis AG

Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI

Philips Medizin Systeme Böblingen GmbH

ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E)

Energy Resources International Co., Ltd.

MAMMOMAT B.brilliant (11372950)

Siemens Medical Solutions USA, Inc.

BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit

C.R. Bard, Inc.

TiLink-L Navigation Instruments

SurGenTec, LLC

Cumulus Functional Neurophysiology Platform

Cumulus Neuroscience Limited

RF Cannula

Shanghai Samedical & Plastic Instruments Co., Ltd.

WHOOP ECG (electrocardiogram) Feature (1.0)

Whoop., Inc.

Disposable Medical Face Mask

Xiantao Zhuobo Industrial Co., Ltd.

Safety Insulin Syringes

Berpu Medical Technology Co., Ltd.

Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)

Shenzhen Imdk Medical Technology Co., Ltd.

AutoContour Model RADAC V2

Radformation, Inc.

Sterilization Wrap

Kenpax International Limited

Knee+

Pixee Medical

Dental Air Polishing Handpiece

Guilin Woodpecker Medical Instrument Co., Ltd.

UltiCare Disposable Pen Needles

Ultimed Incorporated

Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ort

Stryker Leibinger GmbH & Co KG

dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S

Dentona AG

BioSieve™ Marijuana Test Panel 50; BioSieve™ Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Strip 20; BioSieve™ Dx

Vivachek Biotech (Hangzhou) Co., Ltd.

ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)

Zhuhai Pusen Medical Technology Co., Ltd.

Passeo-35 Xeo Peripheral Dilatation Catheter

Biotronik, Inc.

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