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

Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws

Avanti Orthopaedics, Inc.

AirKEE T900

Healkee Medical Pte, Ltd.

ICEfx Cryoablation System (FPRCH8000-02)

Boston Scientific

UV Smart D60

UV Smart Technologies B.V.

Hair Growth Comb (SZ-23,SZ-23A)

Shenzhen Nuon Medical Equipment Co., Ltd.

HOTWIRE™ RF Guidewire

Atraverse Medical

Zeta Navigation System

Zeta Surgical, Inc.

CATAMARAN SI Joint Fusion System

Tenon Medical, Inc.

Portable Folding Electric Wheelchair (Model: DC01)

Anhui Jbh Medical Apparatus Co., Ltd.

Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap

Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC

Momcozy Wearable Breast Pump (BP223)

Shenzhen Root Innovation Technology Co., Ltd.

Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform

Edwards Lifesciences, LLC

iCAS-LV

Highrad , Ltd.

Limfa Therapy System (Limfa Therapy)

Eywa Srl

Perfit CL

Vatech Mcis Co., Ltd.

SCENARIA View Phase 5.0

Fujifilm Corporation

iQ-solutions

Sydney Neuroimaging Analysis Centre Pty, Ltd.

RevoLix HTL

Lisa Laser Products GmbH

Everion+ System

Biofourmis Singapore Pte., Ltd.

STRUXXURE® MCS Anterior Cervical Plate System

Nexxt Spine

AMStent® Tracheobronchial Covered Stent System

Peytant Solutions, Inc.

da Vinci E-200 Electrosurgical Generator

Intuitive Surgical

injeTAK Adjustable Tip Needle (DIS199; DIS201)

Laborie Medical Technologies, Corp.

Lunit INSIGHT MMG

Lunit, Inc.

iCare APP

Ihealth Labs, Inc.

CoLink NeoFuse Plating System

In2bones USA, LLC

XO Cross Support Catheter

Transit Scientific, LLC

AspenView

Aspen Imaging Healthcare, Inc.

IPL HAIR REMOVAL HANDSET, Model: IPL-666

Shenzhen Junbobeauty Technology Co., Ltd.

DEKA Loop

Deka Research and Development

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