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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

RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large

Smith and Nephew Medical Limited

NeuroMatch

LVIS Corporation

MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs

Mentor Worldwide, LLC

Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation

Boston Scientific Neuromodulation

FreedomFlow™ Orbital Circumferential Atherectomy System

Cardio Flow Inc.,

INOSS System

Inosys, Inc.

Merlin Aspiration System

Mivi Neurovascular, Inc.

Alma TED+ System

Alma Lasers, Inc.

BreathID Hp Lab System, BreathID Smart System

Meridian Bioscience Israel , Ltd.

Access anti-HAV IgM

Beckman Coulter, Inc.

Chromix

Termosalud S.L.

DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL

Wrp Asia Pacific Sdn. Bhd.

STA- NeoPTimal

Diagnostica Stago S.A.S

Wearable Breast Pump (Model S21)

Shenzhen TPH Technology Co., Ltd.

POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP™

Boston Scientific Corporation

Bloomlife MFM-Pro

Bloom Technologies NV

PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove

Ineo Tech Sdn Bhd

NeuroQuant PET

Cortechs Labs, Inc.

InfuLife

First Medical Source, LLC

Mg OSTEOINJECT

Bone Solutions, Inc.

Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set

Perfuze, Ltd.

Leforte MMF System

Jeil Medical Corporation

ReneuRx™ (Neural Ice)

Brixton Biosciences

TROJAN SIS Synthetic Latex Condom with Silicone Lubricant

Church & Dwight Co., Inc.

Vathin® Video Bronchoscope System

Hunan Vathin Medical Instrument Co., Ltd.

The SensiTox B. anthracis Toxin Test

First Light Diagnostics, Inc.

DELPHI System

CnS Medical Co., Ltd.

Non Sterile Nitrile Powder Free Examination Gloves – Blue, Green and Black color

Mexpo International, Inc.

Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)

Shenzhen Greatro Electronic Technology Co., Ltd.

Terragene® Bionova® BT20 Biological Indicator

Terragene

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