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

Disposable Medical Nitrile Examination Gloves (Non-sterile)

Suqian Linglian Medical Technology Co., Ltd.

Medical Surgical Mask (Planar type)

Hunan Chopard Medical Devices Co., Ltd.

FIREFLY® Pedicle Screw Navigation Guide

Mighty Oak Medical

Voluson SWIFT; Voluson SWIFT+

Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC

OncoMate MSI Dx Analysis System

Promega Corporation

Altus Spine Navigation System

Altus Partners, LLC

BENCOX Mirabo Z Cup Cortinium

Corentec Co., Ltd.

FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM™ & BALTEUM-ONE™ Lumbar Plate

K&J Consulting Corp.

3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M™ Attest™ Auto-reader (490); 3M™

3M Company

Altaviz Intravitreal Syringe

Altaviz, LLC

Multi-Functional Electrosurgical Knife

Anrei Medical (Hangzhou) Co., Ltd.

Rapid Neuro3D

Ischemaview, Inc.

Premier Resolution System

Trinity Biotech (Primus Corporation, Dba Trinity Biotech)

TeleRehab Aermos Cardiopulmonary Rehabilitation

The ScottCare Corporation

LimFlow Vector

LimFlow, Inc.

UltraCor™ Twirl™ Breast Tissue Marker

Bard Peripheral Vascular, Inc.

PMW01 Procedure Mask Level 1

Defender Safety, Inc.

Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)

Iq Endoscopes Limited

Copra Supreme

Whitepeaks Dental Solutions GmbH

PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)

Primus Sterilizer Company, LLC

Facet 28G Universal Lancet

Facet Technologies, LLC

Lancing device (HH-XV-T)

Tianjin Huahong Technology Co., Ltd.

Q Pedicle Instruments

K2m, Inc.

Disposable Medical Mask

Guangzhou Fuzelong Hygiene Material Co., Ltd.

Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30

Oxoid Limited (Part of Thermo Fisher Scientific)

Idys® LIF

Clariance

MonoStereo

Medicaltek Co., Ltd.

Eyer 2

Phelcom Technologies

Esthetic Colorant

Kuraray Noritake Dental, Inc.

Access anti-HAV IgM

Beckman Coulter, Inc.

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