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

VASSALLO GT 018 Floppy

Filmecc Co., Ltd.

Glidewell™ 3DP Denture Base Resin

Prismatik Dentalcraft, Inc.

The ETHICON™ Total Energy System

Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company)

Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu

B&E Korea Co., Ltd.

EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)

Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

Signature™ ONE System

Orthosoft Inc. (d/b/a) Zimmer CAS

EmbryoSlide+ ic8 dish

Vitrolife A/S

KALA MINI 2.0 (KALA-04)

Shenzhen Kaiyan Medical Equipment Co., Ltd.

Venus BlissMAX

Venus Concept USA, Inc.

SPY Cystoscope/Hysteroscope

Stryker Endoscopy

Precice™ Max System and Precice™ Ankle Salvage System

NuVasive Specialized Orthopedics

Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily

Yung Sheng Optical Co., Ltd.

Disposable Percutaneous Nephrostomy Dilatation Kit

Shenzhen Trious Medical Technology Co., Ltd.

Osteoboost Belt

Bone Health Technologies, Inc.

inspired™ VHB20 Heated Humidifier

Vincent Healthcare Products Limited

Fibercure

Lumendo AG

Cemented Plus Abutment

Unidental Co., Ltd.

Surgical Gown, Reinforced Surgical Gown

Wuhan Zonsen Medical Products Co., Ltd.

3Dicom MD

Singular Health Pty, Ltd.

visio.lign color, visio.lign shield

Bredent GmbH & Co. KG

HVT 2.0

Vapotherm, Inc.

The Acumed Wrist Fixation System - 2.4mm Screws

Acumed, LLC

Pastelle

Wontech Co., Ltd.

Cerebral Autoregulation Index (CAI) Algorithm

Edwards Lifesciences

Meduloc Intramedullary Fracture Fixation (IFF) System

Meduloc, LLC

CardioPhase® hsCRP

Siemens Healthcare Diagnostic Products GmbH

MIST IC

Imagine Milling Technologies, LLC

Dynamo™ Spinal Cement; Salvo® Spine System

Spine Wave, Inc.

Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Strea

Medtronic, Inc.

da Vinci SP Surgical System (SP1098)

Intuitive Surgical, Inc.

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