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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

V-soft Line™ Barbed Surgical Suture (Various)

Feeltech Co., Ltd.

VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH

Remington Medical, Inc.

Protrieve Sheath

Inari Medical, Inc.

Gastric Alimetry System

Alimetry , Ltd.

Bone Anchor (NGS-BA-01)

ClearPoint Neuro, Inc.

Bioscope Neuromonitor Device

Biosys Biyomedikal Muhendislik San. VE Tic. A.S.

eRAD PACS

Erad, Inc.

Q21

Neurofield, Inc.

Primum Hydrophilic Guiding Catheter

Pendracare

Leaderflex Mini and Leaderflex Nano

Vygon USA

DeltaNEC Interbody System

Nexus Spine

Argus Cognitive ReVISION Software

Argus Cognitive, Inc.

Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (

Speciality Fibres and Materials Limited

Arthrx Fracture Plates

Arthrex, Inc.

MultiPulse HoPLUS

Asclepion Laser Technologies GmbH

CM005 Standard (CM005); CM004 Mini (CM004)

Connexicon Medical , Ltd.

AI-Rad Companion Organs RT

Siemens Medical Solutions U.S.A.

Bakri Essential Postpartum Balloon

Cook Incorporated

Benchmark BMX96 Access System

Penumbra, Inc.

Aura Wave

Aura Wellness, LLC

Power wheelchair (N6101)

Zhejiang Zhonglei Medical Technology Co. , Ltd.

Ear Pressure Relief Device(Model:ER813B)

Ningbo Albert Novosino Co., Ltd.

RadioLens v1.0

Synapsica

Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing

Coagusense, Inc.

LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equ

Physio-Control, Inc.

Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104)

Unimed Medical Supplies, Inc.

Intense Pulsed Light Treatment System (LK-PT)

Nanjing Bestview Laser S&T Co., Ltd.

Portable Folding Electric Wheelchair (Model: DC01)

Anhui Jbh Medical Apparatus Co., Ltd.

Grappler Suture Anchor System

Paragon 28, Inc.

Contour ProtegeAI

Mim Software, Inc.

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