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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