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

HWC 2016-04-29

MC-Subtalar(TM) II

Applicant Merete Medical GmbH

K-Number K160548

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LPH 2016-04-29

Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug

Applicant Corentec Co., Ltd.

K-Number K152084

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LEJ 2016-04-29

T-32;T-40;T-44;T-52;T-72;TT-50

Applicant Tanses Technologies, Inc.

K-Number K152412

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FYA 2016-04-28

Blockade Surgical Gown

Applicant Medline Industries, Inc.

K-Number K150598

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ONX 2016-04-28

ARCHITECT ROMA

Applicant Fujirebio Diagnostics,Inc.

K-Number K151502

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EBF 2016-04-28

BRILLIANT EVERGLOW

Applicant Coltene/Whaledent AG

K-Number K152927

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FFX 2016-04-28

ManoScan System

Applicant Given Imaging , Ltd.

K-Number K151086

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GEI 2016-04-28

Endopath Electrosurgery Probe Plus II

Applicant Ethicon Endo-Surgery, LLC

K-Number K160128

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PNN 2016-04-28

3Shape Ortho System

Applicant 3Shape A/S

K-Number K152086

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NUC 2016-04-27

Wet Original Personal Lubricant

Applicant Trigg Laboratories D/B/A Wet International

K-Number K160211

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LZG 2016-04-27

OmniPod Insulin Management System

Applicant Insulet Corporation

K-Number K160252

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KWQ 2016-04-27

Pyrenees Cervical Plate System

Applicant K2m

K-Number K153526

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