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
Nihon Kohden NKV-550 Series Ventilator System
Nihon Kohden Orangemed, LLC
RHYTHMIA HDx Mapping System
Boston Scientific Corporation
Vanquish Water Vapor Ablation Device
Francis Medical, Inc.
AVIEW CAC
Coreline Soft Co., Ltd.
Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-52
Hangzhou AGS MedTech Co., Ltd.
AngioWaveNet
Angiowave Imaging, Inc.
DERMABOND PRINEO Skin Closure System
ETHICON, Inc.
Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 9
Sonoscape Medical Corp.
Power wheelchair
Zhejiang Zhonglei Medical Technology Co. , Ltd.
ABTross ALIF Expandable Cage System
Aegis Spine, Inc.
Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for
Summit Glove, Inc.
Cable-Ready® Cable Grip System
Pioneer Surgical Technology, Inc.
LYMA Laser
Lyma Life , Ltd.
FloPatch FP120
Flosonics Medical
The IQoolTM System
Braincool AB
1060nm laser body slimming machine
Hebei JT Medical Co., Ltd.
BlueStar and BlueStar Rx
Welldoc, Inc.
Immunalysis Tapentadol Urine HEIA
Lmmunalysis Corporation
Mould Probe MR Safe
Varian Medical Systems, Inc.
BRM TOOL Screws
Brm Extremities Srl
PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter
Medos International SARL
Stryker AlphaVent Knotless SP Biocomposite Anchor
Stryker Endoscopy
MagnetOs Putty
Kuros Biosciences B.V
Monoject Enteral Syringe with ENFit Connector (401SE); Monoject Enteral Syringe with ENFit Connector (403SE); Monoject
Cardinalhealth
FebriDx Bacterial/Non-bacterial Assay
Lumos Diagnostics, Inc.
FAQ (102)
Foreo, Inc.
AQUA Laminoplasty Systems
ZheJiang Decans Medical Devices Co., Ltd.
Taurus Clip
Taurus Endoscopy
Laon Ortho
Laon Medi, Inc.
PhasTIPP
LeMaitre Vascular, Inc.
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