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

Provena(TM) Midline Catheter

C.R. Bard, Inc.

3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix

Deltamed GmbH

Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ C

ArthroCare Corporation

Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)

Aveera Medical, Inc.

ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSL

Ethicon Endo-Surgery, LLC

Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W

Spectrum Medical S.R.L.

Cell-Free DNA BCT

Streck, Inc.

Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Reso

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Synthetic Polymer Glove - Polyethylene (Black)

Ur Industry Sdn Bhd

VOLT™ Proximal Humerus 3.5 Plating System

Synthes GmbH

aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar

Carlsmed, Inc.

Disposable Warming Blanket

Hangzhou Tappa Medical Technology Co., Ltd.

Luja Set

Coloplast Corp.

Virage® OCT Spinal Fixation System

Highridge Medical, LLC

CuffTrek

Shanghai Longmann Tech Co., Ltd.

Zenition 90

Philips Medical Systems Nederlands B.V.

Disposable Medical Surgical Mask

Weihai Dishang Medical Technology Co., Ltd.

Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)

Exceleron Medical

EL CAPITAN Anterior Lumbar Interbody Fusion System

Astura Medical

SmarTooth

Smartooth Co., Ltd.

syngo Application Software

Siemens Medical Solutions USA, Inc.

Infrared Thermometer TET-351

Truly Instrument Limited

InfaTherm Disposable Infant Warming Mattress

International Biomedical

da Vinci SP Surgical System (SP1098)

Intuitive Surgical, Inc.

UNO Negative Pressure Wound Therapy System

Genadyne Biotechnologies, Inc.

Surgical Face Mask

Taiwan Comfort Champ Manufacturing Co., Ltd.

GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/X

Genabio Diagnostics, Inc.

TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)

Ningbo Tianyi Medical Appliance Co., Ltd.

MedCAD® AccuStride™ System

Medcad

SofWave System

Sofwave Medical, Ltd.

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