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

HSD 2016-11-21

Arthrex Univers Revers Shoulder Prosthesis System

Applicant Arthrex, Inc.

K-Number K161782

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NUH 2016-11-21

Electronic Pulse Stimulator

Applicant Beijing Choice Electronic Technololgy Co., Ltd.

K-Number K160508

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KLE 2016-11-21

HC Primer

Applicant Shofu Dental Corporation

K-Number K161891

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DXR 2016-11-21

CorSens

Applicant Corsens Medical , Ltd.

K-Number K160656

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LZA 2016-11-21

Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs

Applicant Shandong Baisheng Medical Products Co., Ltd.

K-Number K161944

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IYE 2016-11-18

Dosimetry Check Version 5 Release 1

Applicant Math Resolutions, LLC

K-Number K162577

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IYX 2016-11-18

Discovery NM 750b Bopsy

Applicant GE Healthcare

K-Number K160933

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OAP 2016-11-18

Capillus302, Capillus312, Capillus352

Applicant Capillus, LLC

K-Number K162994

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LNH 2016-11-18

HyperBand

Applicant Ge Medical Systems, LLC

K-Number K162403

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LZU 2016-11-18

LacriPro Punctum Plug

Applicant Lacrimedics, Inc.

K-Number K161673

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KDI 2016-11-18

RAPIDO HOLLOW-FIBRE DIALYZERS

Applicant Bellco Srl

K-Number K160558

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FRG 2016-11-18

PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator

Applicant Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti

K-Number K160595

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