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

Lancing device

Tianjin Huahong Technology Co., Ltd.

FlashHeal 2 (FlashHeal 2.0)

Inwound Aps

VersaWrap

Alafair Biosciences, Inc.

prodisc® L Instruments

Centinel Spine, LLC

Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)

Coloplast

Bausch + Lomb Preservative Free Lubricating and Rewetting Drops

Bausch & Lomb, Incorporated

Albumin BCG2

Abbott Ireland Diagnostics Division

Peridot-EX Expandable Intervertebral Body Fusion System

Gbs Commonwealth Co., Ltd.

Procedure Mask, Surgical Mask

A Plus International, Inc.

Dreem 3S

Beacon Biosignals, Inc.

Adhese Universal DC, Cention Primer

Ivoclar Vivadent, AG

Respiratory Muscle Trainer

Chongqing Moffy Innovation Technology Co., Ltd.

SOLID CLIP™ Single Use Clip Applier

Medscope Biotech Co., Ltd.

Ceragem Automatic Thermal Massager (CGM MB-2401)

Ceragem Co., Ltd.

Fluido Compact System

The Surgical Company International B.V.

Frida™ Anterior Cervical Plate System

Spineup, Inc.

R2P Radifocus Glidewire Advantage

Terumo Corporation

B-Scan

Accutome, Inc. Doing Business AS Keeler USA

SeptAlign (SPLN001)

Spirair, Inc.

Aevumed PHANTOM Suture Anchors

Aevumed, Inc.

xvision Spine system

Augmedics, Ltd.

TearCare System

Sight Sciences, Inc.

Atlas Spine HiRISE™ Expandable Cervical Corpectomy System

Atlas Spine, Inc.

Remanufactured EndoWrist Cadiere Forceps (420049)

Rebotix

IPL hair removal machine

Shenzhen Borria Technology Co., Ltd.

Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Sunray Medical Products, Inc.

Arthrex AlloSync PushLock Suture Anchor

Arthrex, Inc.

QuikClot Control+ Hemostatic Dressing

Z-Medica, LLC

AllTest Urinary Tract Infection Test

Hangzhou AllTest Biotech Co., Ltd.

Intensity Pulsed Light Therapy System

Beijing Adss Development Co., Ltd.

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