Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

LZA 2018-04-26

Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue

Applicant Top Glove Sdn. Bhd.

K-Number K172923

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NFO 2018-04-26

2 Face / Face Evolution

Applicant Heat IN A Click

K-Number K171821

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FCG 2018-04-26

Beacon EUS Access System

Applicant Covidien, LLC

K-Number K180037

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NAY 2018-04-26

Intuitive Surgical EndoWrist Vessel Sealer Extend

Applicant Intuitive Surgical, Inc.

K-Number K173337

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LJS 2018-04-26

3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology

Applicant C.R. Bard, Inc (Bard Has Joined Bd)

K-Number K180548

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GEI 2018-04-26

ESG-300, APU-300, Pressure Reducer, MAPC Probes

Applicant Olympus Winter & Ibe GmbH

K-Number K180200

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EOQ 2018-04-26

LungVision Tool

Applicant Bodyvision Medical , Ltd.

K-Number K172955

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OUR 2018-04-26

UNITY Sacroiliac Joint Fixation System

Applicant Huvexel Co. , Ltd.

K-Number K173201

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NKB 2018-04-26

ENNOVATE®

Applicant Aesculap Implant Systems, LLC

K-Number K180433

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CBK 2018-04-26

Astral 100/150

Applicant Resmed, Ltd.

K-Number K172875

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HQD 2018-04-25

OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens

Applicant Contamac, Ltd.

K-Number K180616

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KPS 2018-04-25

VERITON NM

Applicant Spectrum Dynamics Medical, Ltd.

K-Number K180514

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