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

Ion-L Navigated Instruments

SurGenTec, LLC

Glucose2

Abbott Ireland

Tempus ECG-Low EF

Tempus AI, Inc.

Explorer Air II

Surgvision GmbH

HFT150

Invent Medical Corporation

IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™

Alphatec Spine, Inc.

EVAC-MRI

Phasor Health, LLC

IGAR System (1001.A)

Insight Medbotics, Inc.

Automatic Digital Blood Pressure monitor (LD-526)

Honsun (Nantong) Co., Ltd.

Synq Software Version 1.3

Synaptive Medical, Inc.

FreeStyle Comfort (AS200 / FreeStyle Comfort)

Caire, Inc.

Bone Bolt System

University of Utah, Department of Orthopaedics

cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems

Roche Molecular Systems, Inc.

BreatheBand® (Model 1000)

Exemplar Medical, LLC

Aveta System 2.0

Meditrina, Inc.

Disposable Pre-calibrated Brain Biopsy Needle 2.0

PAJUNK GmbH Medizintechnologie

SpineUs™ System

Verdure Imaging

Disposable Automatically Retractable Safety Syringes (with detachable needle)

Shantou Wealy Medical Instrument Co.,Ltd

NOVA RESIN dual cure, self adhesive resin cement

Imicryl Dis Malzemeleri Sanayi VE Ticaret AS

Hoffmann LRF System

Stryker GmbH

Capnostream™35 Portable Respiratory Monitor (PM35MN)

Covidien, LLC

OutFlo Aortic Valve Dilatation Balloon Catheter

Disa Medinotec

Arthrex Knotless Mini TightRopes

Arthrex, Inc.

Optima Coil System (Optima Packing Coil System)

Balt USA, LLC

BioProtect Balloon Implant™ System

Bioprotect, Ltd.

HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)

Owens & Minor (O&M) Halyard, Inc.

14HQ901G-B

Lg Electronics.Inc

Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355)

Shenzhen Bsx Technology Electronics Co., Ltd.

Montblanc Plate System

Medifield Medical Co., Ltd.

DEKA Loop

Deka Research and Development

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