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

LYZ 2018-06-12

Powder Free Vinyl Patient Examination Gloves (Yellow, White)

Applicant Shanxi Hongjin Plastic Technology Co., Ltd.

K-Number K180260

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KPS 2018-06-12

HeartSee Cardiac P.E.T. Processing Software

Applicant Bracco Diagnostics, Inc.

K-Number K181343

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QCC 2018-06-12

DreaMed Advisor Pro

Applicant DreaMed Diabetes, Ltd.

K-Number DEN170043

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NRY 2018-06-11

SOFIA Plus Aspiration Catheter

Applicant MicroVention, Inc.

K-Number K173200

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HRX 2018-06-11

Endiscope, Endiscope Cervical

Applicant Elliquence, LLC

K-Number K180766

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DQY 2018-06-11

Phenom 27 Catheter

Applicant Cathera, Inc.

K-Number K180959

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LZA 2018-06-11

Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color

Applicant Ever Global (Vietnam) Enterprise Corp

K-Number K171422

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FMI 2018-06-11

Omnican fine

Applicant B.Braun Medical, Inc.

K-Number K173803

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DZE 2018-06-11

Ti-one 101 TS Dental Implant System

Applicant Hung Chun Bio-S Co., Ltd.

K-Number K172821

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GEI 2018-06-11

Pollogen Legend System

Applicant Pollogen, Ltd.

K-Number K173503

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LYZ 2018-06-11

Vinyl Examination Glove (Clear, Non-Colored)

Applicant Huifu Trading Co., Ltd.

K-Number K180849

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HIF 2018-06-11

GRI-Alleset Veress Needle

Applicant Gri Medical and Electronic Technology Co., Ltd.

K-Number K172835

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