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
Epione
Quantum Surgical Sas
ExcelsiusXR
Globus Medical, Inc.
enCore Impression Material
Encore Guards
Vivatmo pro-S
Bosch Healthcare Solutions GmbH
METIC- Airway Balloon Catheter
M/S Meril Life Sciences Pvt. , Ltd.
ADVIA Centaur Cytokeratin Fragment 21-1
Fujirebio Diagnostics,Inc.
EyeBOX SNAP
Oculogica, Inc.
da Vinci SP Firefly Imaging System
Intuitive Surgical, Inc.
ME-APDS; MAGENTIQ-COLO
Magentiq Eye, Ltd.
5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter
Medtronic Vascular
ROCC Console
Philips Medical Systems Nederland B.V.
Electric wheelchair
Foshan Dahao Medical Technology Co., Ltd.
Percent Oxygen Sensors
Careox, LLC
FUJIFILM Endoscope Model EB-710XT
FUJIFILM Healthcare Americas Corporation
Legend Pro DMA
Pollogen, Ltd.
VariSeed (v10)
Varian Medical Systems
Derma-Gide
Geistlich Pharma AG
AI-Rad Companion (Cardiovascular)
Siemens Medical Solutions U.S.A.
TheraSphere 360 Y-90 Management Platform
Boston Scientific Corporation
Vista CMS
Shanghai Draeger Medical Instrument Co., Ltd.
X-PAC® N-GAGE Lumbar Plate System
Expanding Innovations, Inc.
ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
Ulrich GmbH & Co. KG
Revogene
Meridian Bioscience, Inc.
Prevena Plus 125 Therapy Unit
3M
iLoop Interventional Coil 0.55T
Noras Mri Products GmbH
Powder Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, and Select Othe
Lingshi Hongruida Health Protection Technology Co., Ltd.
Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K
Magnus Medical, Inc.
Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
Shenzhen Ulike Smart Electronics Co., Ltd.
Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter
Edwards Lifesciences, LLC
EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE Ultra Rods
Medos-International Sarl
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