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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