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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

Stat Profile Prime Plus Analyzer System

Nova Biomedical Corporation

REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component

Osteoremedies, LLC

VHT-200 Wound Treatment System

Vaporox, Inc.

TRACOE vario

Tracoe Medical GmbH

LVivo Software Application

Dia Imaging Analysis, Ltd.

FEMTO LDV Z8 Femtosecond Surgical Laser

Sie Ag,Surgical Instrument Engineering

Smart Scope® CX

Periwinkle Technologies Pvt., Ltd.

DLP™ Silicone Coronary Artery Ostial Cannulae

Medtronic, Inc.

Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System

Maquet Cardiovascular, LLC

Purema® H Hemoconcentrator (EtO Sterilized)

Tecnoideal America

BonOs Inject Bone Cement; NEO Pedicle Screw System

Neo Medical SA

Pediatric Plating Platform Hip

OrthoPediatrics Corp.

brAIn™ Shoulder Positioning

Avatar Medical

Venera 608 Deep Vein Thrombosis (DVT) Prevention System

Suzhou Minhua Medical Apparatus Supplies Co., Ltd.

EsCom250

Spident Co., Ltd.

Loss of Pulse Detection

Fitbit

Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula

Restore Robotics

LEGACY

Phasor Health, LLC

BrainTemp Neonate System (BTNeo System)

Brain Temp, Inc.

LOCATOR® Angled Abutment

Zest Anchors, LLC

BioFire COVID-19 Test 2

Biofire Defense, LLC

Saige-Density

DeepHealth, Inc.

ADAS 3D

Adas3D Medical S.L.

Endoform Dermal Template

Aroa Biosurgery , Ltd.

°M Warmer System with °M Station

Mequ A/S

BeneVision Central Monitoring System

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Premier Resolution System

Trinity Biotech (Primus Corporation, Dba Trinity Biotech)

Oxygen Concentrator (J5A)

Foshan Kycare Medical Equipment Co., Ltd.

SUPERTILT PLUS (STP)

Power Plus Mobility

TigerConnect Alarm Management

Tigerconnect

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