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

Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Im

Wuxi Hisky Medical Technologies Co., Ltd.

LOTUS Series 4 Enhanced Shears, LOTUS Series 5

Sra Developments, Ltd.

Grass® MR Conditional/CT Cup Electrodes

Natus Manufacturing Limited

Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U10

Unimed Medical Supplies, Inc.

Universal Seal (5-12 mm)

Intuitive Surgical, Inc.

Masimo CARESCAPE SpO2 – Masimo with SpHb

Masimo Corporation

Disposable Laryngeal Electrodes

Suzhou Haishen Medical Device Associates Co., Ltd.

NuVasive Cohere ALIF System Intervertebral Body Fusion Device

Nu Vasive, Incorporated

Icona Hip Stem

Corin U.S.A. Limited

Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US)

Shanghai AnQing Medical Instrument Co., Ltd.

Sleep Apnea Feature

Samsung Electronics Co., Ltd.

Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14

Poly Medicure Limited

Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs

Anhui Xinyisheng Medical Technology Co.,Ltd

EZ-FIDUCIALS

Phasor Health, LLC

Elemental Granulate

Zinkh NV

Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5

Canon Medical Systems Corporation

HIGHERDOSE Body Sculptor (Model: GS-03)

Shenzhen Kaiyan Medical Equipment Co., Ltd.

A.L.P.S. Proximal Humerus Plating System

Zimmer Biomet

Lumify Diagnostic Ultrasound System

Philips Ultrasound, LLC

DD Hybridlayer (multicolored zirconia)

Dental Direkt GmbH

VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System

B.Braun Medical, Inc.

EdgePro

Biolase, Inc.

Kubec Xpert 80 Radiography System

Kub Technologies, Inc.

3M Filtek Supreme Flowable Restorative

3M Company Espe Dental Products

Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath

Suzhou Endophix Co., Ltd.

Baylis Connector Cable

Baylis Medical Technologies, Inc.

UNiD™ Spine Analyzer (SW3002)

Medicrea International S.A.S. (Medtronic)

Infinity™ OCT System

Medtronic Sofamor Danek USA, Inc.

Hemoclip

Hangzhou AGS MedTech Co., Ltd.

Cool-tip RF Ablation System E Series

Covidien, LLC

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