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

VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Ma

Acist Medical Systems, Inc.

Ivory Glove Powder-Free Nitrile Examination Gloves

Ivory Gloves Sdn. Bhd.

SoftSpot

Pediametrix, Inc.

Dental Implant Unit

Guilin Aesthedent Medical Instruments Co., Ltd.

VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box

Medimaging Integrated Solution, Inc (Miis)

Celebrace Software

Celebrace

Acumed Wrist Plating System

Acumed, LLC

Bridge Plus Occlusion Balloon (590-002)

Philips Image Guided Therapy Devices

Humask Pro Vision, Humask Pro Vision 3000

Entreprise Premont, Inc.

QOCA Portable ECG Monitoring Device

Quanta Computer, Inc.

Vinyl/Nitrile Blend Exam Glove

Dezhou Hengchang Medical Technology Co., Ltd.

REGER Nebulizer Irrigation Cannula

Reger Medizintechnik, GmbH

Disposable Radiofrequency Cannula

ABBOTT MEDICAL

Revi System

Bluewind Medical , Ltd.

Diode Laser Hair Removal System (SH-VD910)

Beijing Sea Heart International Science and Technologyco.Ltd

Safety Insulin Pen Needles

Zhejiang Kindly Medical Devices Co., Ltd.

XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5

Canon Medical Systems Corporation

Bullsai Confirm

Turing Medical Technologies, Inc.

EchoNavigator R4.0

Philips Medical Systems Nederland B.V.

TORPEDO Implant System®

Deltacor GmbH

Wrist Blood Pressure Monitor, Blood Pressure Monitor

Andon Health Co, Ltd.

Safecare Urinary Tract Infection Test

Safecare Biotech (Hangzhou) Co., Ltd.

MIRA Surgical System

Virtual Incision

Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System

Boston Scientific

Augmented Gingival Matrix

Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.

Powered Wheelchair (NXN20-208, NXN20-211)

Zhejiang Nysin Medical Co., Ltd.

Quell-FM

Neurometrix, Inc.

1 Series Phototherapy Equipment

Daavlin Distributing Co.

SP-CL Hip Stem and LCU Hip System

Waldemar Link GmbH & Co. KG

EOlife®

Archeon

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