RecallHawk

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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