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

SpyGlass Discover Balloon Dilation Catheter

Boston Scientific Corporation

Precice Ankle Salvage System

Nuvasive Specialized Orthopedics, Inc.

Pytheas Your Guided Trajectory

Pytheas Navigation Sas

Cryopush Cold Compression Device (A02-P-001)

Chengdu Cryo-Push Medical Technology Co.,Ltd

InstaFAN

Onepass Medical , Ltd.

StealthStation Cranial Software, v3.1.5 (9735585)

Medtronic Navigation, Inc.

Organic Cotton Tampon; Organic Cotton PESCVcord Tampon

Suzhou Borage Medical Technology Co., Ltd.

Symani Surgical System

Medical Microinstruments, Inc.

Disposable Endoscopy Adapter Set

Yangzhou Fartley Medical Instrument Technology Co., Ltd.

CREED™ Cannulated Screws

Glw, Inc.

XeliteMed VertehighFix High Viscosity Spinal Bone Cement

Xelite Biomed , Ltd.

3-Ply Disposable Medical Mask

Wealth Lead Industrial Limited

AirKEE P900

Healkee Medical Pte, Ltd.

MICOR 700 with Auto I/A

Carl Zeiss Meditec Cataract Technology, Inc.

CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test

CorDx, Inc.

Pectus Blu System

Biomet Microfixation

Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical G

Dukal Corporation

TriMed Compression Screws

TriMed, Inc.

Tecomet Global Unite Short Stem Instrumentation

Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc.

Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay

Diazyme Laboratories, Inc.

BD Nano 2nd Gen Pen Needle

Becton, Dickinson and Company

17HQ701G-B

Lg Electronics.Inc

BriefCase

Aidoc Medical , Ltd.

T-Line Hernia Mesh

Deep Blue Medical Advances, Inc.

VEA Align; spineEOS

Eos Imaging

Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables

Medtronic, Inc.

FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)

Sutter Medizintechnik GmbH

Stratum® Ankle Fusion Plating System

Nextremity Solutions, Inc.

Erchonia Zerona® VZ8

Erchonia Corporation

VALORY

Agfa N.V.

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