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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

Viz HDS, Viz Volume Plus, Viz ICH+

Viz. Ai, Inc.

Cristaline Aligners Z FLX

Cristaline Aligners GmbH

Geniant Cranial (Navigated Neurosurgical Positioning Robot)

Koh Young Technology, Inc.

Diode laser device (RF3120-BI)

Risu Medical Technology Co., Ltd.

SANSA HSAT

Huxley Medical

JLK-ICH

JLK, Inc.

eMVFit (MVF-10M)

Weero Co., Ltd.

ProSeal™ Closed System Bag Access

Epic Medical Pte. , Ltd.

GelPOINT V-Path Vaginal Access System

Applied Medical Resources Corporation

StealthFix Intraosseous Fixation System

Medartis, Inc.

MD-320W Ultrasound Biomicroscope

MEDA Co., Ltd.

Deep Learning Image Reconstruction

Ge Healthcare Japan Corporation

Access BR Monitor

Beckman Coulter, Inc.

LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation

Corentec Co., Ltd.

Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)

Shanghai AnQing Medical Instrument Co., Ltd.

Non-sterile, Powder-Free Latex Examination Glove

Sri Trang Gloves (Thailand) Public Company Limited

Extroducer Infusion Catheter System

SmartWise Sweden AB

FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN)

ZuriMED Technologies AG

Fundus On Phone Non Mydriatic (FOP NM-10)

Remidio Innovative Solutions Private Limited

Manual Wheelchair (W47)

Jiangsu Jumao X-Care Medical Equipment Co., , Ltd.

Agile Esophageal Stent System

Boston Scientific Corporation

Porous Biologic Scaffold

Ventris Medical

SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter

Cordis US Corp

Flexx Junior (FLX-J00, FLX-J50)

Karma Mobility Co, Ltd.

Salvo® Spine System

Spine Wave, Inc.

RFG-01

Zimmer Medizinsysteme GmbH

Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White)

Zibo Shengkun Chemical Industry Co., Ltd.

TauTona Pneumoperitoneum Assist Device (TPAD)

Tautona Group

BENCHMARK BMX81 Access System

Penumbra, Inc.

GLP systems Track

Abbott Laboratories

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