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

SILKRO

Hironic Co., Ltd.

K-ASSAY CRP (Ver.2)

Kamiya Biomedical Company, LLC

Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug)

Inner Mongolia Cureguard Medical Technology Co., Ltd.

Konig Mogen Clamp

Medline Industries, Inc.

Hearing Aid Feature (HAF)

Apple, Inc.

Fastplex™ BCR-ABL (p210) %IS digital PCR Kit

Suzhou Precigenome, Ltd. Co;

MAGNETOM Viato.Mobile

Siemens Medical Solutions USA, Inc.

TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System

Smith & Nephew, Inc.

VYBE RF Electrosurgical System

ShenB Co., Ltd.

Hi bebe super (BT-150B)

Bistos Co., Ltd.

EveryWare

Breas Medical AB

Arthrex FiberTak Suture Anchor

Arthrex, Inc.

ViewFlex™ X ICE Catheter, Sensor Enabled™

ABBOTT MEDICAL

AMT G-Tube Balloon Gastrostomy Feeding Device

Applied Medical Technology, Inc.

EdgePro

Biolase, Inc.

VM-2000

Ventis Medical, Inc.

Surgical Face Mask (Non-sterile)

Hubei Kimsoul Industrial Co., Ltd.

Pentax Medical Valve Set

Yangzhou Fartley Medical Instrument Technology Co., Ltd.

contact forte Alpha

Bhm-Tech Produktionsgesellschaft Mbh

powder free nitrile examination glove - white, non-sterile

Hong Seng Gloves Sdn Bhd

UL UHD-Clear View 4K Camera System (UL-3Chip 4K)

Univlabs Technologies Private Limited

Philips IntelliSite Pathology Solution 5.1

Philips Medical Systems Nederland B.V.

ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter

Siemens Medical Solutions USA, Inc.

Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exc

Zoll Circulation, Inc.

Kinos Total Ankle System

Restor3D

Enivo™

Aroa Biosurgery , Ltd.

Sonosite LX Ultrasound System

FUJIFILM Sonosite, Inc.

Double Tube Herbst Appliance

The Tmj Clinic PC

Saige-Dx

DeepHealth, Inc.

Maxiocel Chitosan Wound Dressing

Advamedica, Inc.

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