Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

OBT 2018-05-15

Guided Growth Plate System Plus

Applicant Orthofix Srl

K-Number K180624

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QEW 2018-05-15

Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister

Applicant Penumbra, Inc.

K-Number K180412

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EMA 2018-05-15

Metacem

Applicant Meta Biomed Co., Ltd.

K-Number K171449

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OHS 2018-05-15

reVive Light Therapy LED Ultrasonic Wrinkle System

Applicant Led Technologies, Inc.

K-Number K180445

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MQB 2018-05-15

VIVIX-S 1717V

Applicant Vieworks Co., Ltd.

K-Number K181003

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LZC 2018-05-15

Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs

Applicant Comfort Rubber Gloves Industries Sdn. Bhd.

K-Number K180476

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OCX 2018-05-14

Disposable Biopsy Valve

Applicant Zhejiang Chuangxiang Medical Technology Co., Ltd.

K-Number K173758

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IYN 2018-05-14

Clarius Ultrasound Scanner

Applicant Clarius Mobile Health Corp.

K-Number K180799

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NHA 2018-05-14

Dentium Implantium & SuperLine Prosthetics

Applicant Dentium Co., Ltd.

K-Number K172640

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FMI 2018-05-14

RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder

Applicant Myco Medical Supplies, Inc.

K-Number K173279

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MUE 2018-05-14

Pristina Serena

Applicant GE Healthcare

K-Number K173576

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IYN 2018-05-14

Ventripoint Medical System Plus (VMS+)

Applicant Ventripoint Diagnostics , Ltd.

K-Number K173810

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