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

Dental Scaler and Air Polisher

Guilin Woodpecker Medical Instrument Co., Ltd.

V80 Anesthetic Vaporizer (V80)

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Syngo Carbon Clinicals

Siemens Healthcare GmbH

mi-eye 3 needlescope with cannula, mi-tablet 3

Trice Medical, Inc.

Apex Flex

Sprintray, Inc.

NightOwl

Ectosense NV

LONGY Implant and LONGY-N Implant

Noris Medical , Ltd.

MARVEL™ Growing Rods

Globus Medical, Inc.

Galen ES Cooperative Surgical Assistant Platform, Galen ES

Galen Robotics

Powered Wheelchair (NXN20-205, NXN20-205M)

Zhejiang Nysin Medical Co., Ltd.

Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentan

Gmp Medicare Sdn. Bhd.

NAJA Gastrointestinal Catheter

Chess Medical, Inc.

Zuno Smart Sterilization Container

Zuno Medical, Inc.

E1000 Dx Digital Pathology Solution

Shandon Diagnostics Limited

Blue Nitrile Exam Gloves

Jiangxi Surefine Medical Co., Ltd.

E3D™-C Interbody System

Evolution Spine

Tomey Cornea/Anterior Segment OCT (CASIA2)

Tomey Corporation

Neuromuscular Transmission Monitor TOF3D (2510091)

MIPM Mammendorfer Institut für Physik und Medizin GmbH

HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Ki

Access Vascular, Inc.

Inspire HCR and HCR DUAL cardiotomy reservoirs

Sorin Group Italia S.R.L.

Soteria.AI

Omega Medical Imaging, LLC

ST AIA-PACK BNP Assay

Tosoh Bioscience, Inc.

OsseoFit Stemless Shoulder System

Zimmer, Inc.

BD Texium™ Closed Male Luer

Care Fusion

InferCare RECIST

Beijing Infervision Healthcare Medical Technology Co., Ltd.

LED Facial Mask

Shenzhen Sunsred Technology Co.,Ltd

Disposable Medical Examination Nitrile Gloves

Raxwell Industrial, LLC

DreamClear

Somnomed Technologies Inc., Doing Business AS Remware

Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets

Owen Mumford, Ltd.

LifeLens Wireless ECG Monitor

LifeLens Technologies, Inc.

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