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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

Disposable Medical Surgical Mask

Jiangxi Bestgrand Health Technology Co., Ltd.

J-Temp

Ultradent Products, Inc.

MDx-Chex for BC-GN

Streck

IPL Hair Removal

Shenzhen Qiaochengli Technology Co., Ltd.

SACS PRO

Elastimed , Ltd.

HydraDose Vaginal Suppositories

MD Labs, LLC

Electric Scooter (M2085, S2091)

Guangdong Prestige Technology Co., Ltd.

I.V. Administration Set

Bq Plus Medical Co., Ltd.

SafePort(TM) Manifold (or Stopcock)

Elcam Medical Acal

angiOCCLUDE Ligating Clips

A2 Medical Systems, LLC

Warantec Custom Abutment

Warantec Co., Ltd.

FAMA Male Latex Condoms

Shanghai Personage Hygiene Products Co., Ltd.

Fogg System Patient Monitoring Cables

Fogg System Company, Inc.

FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000

Fresenius Medical Care Renal Therapies Group, LLC

Vecttor VT-300

Artaflex, Inc.

LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)

Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.

myAir

Resmed Corp

Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and F

Central Medicare Sdn Bhd

OviTex PRS

TELA Bio, Inc.

Ventripoint Medical System Plus (VMS+) 4.0

Ventripoint Diagnostics , Ltd.

Synchfix EVT

Wright Medical Technology, Inc. (Stryker Corporation)

Mjolnir Pro. (Multi–electrode plasma)

Shenzhen Leaflife Technology Co., Ltd.

Zeta Cranial Navigation System

Zeta Surgical

EKGenius Smart System

Ekgenius, LLC

ADSEAL Plus

Meta Biomed Co., Ltd.

Diode laser device (BM091)

Hebei Newangie Technology Co., Ltd.

United Orthopedic Knee Patient Specific Instrumentation

Enhatch, Inc.

Annalise Enterprise CTB Triage-OH

Annalise-Ai Pty , Ltd.

Persona® Personalized Knee System

Zimmer Switzerland Manufacturing GmbH

Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1);

Surgify Medical OY

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