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

MBI 2016-08-03

AFX™ Femoral Implant With Inserter

Applicant Cayenne Medical, Inc.

K-Number K161033

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FRO 2016-08-03

DURAFIBER Ag

Applicant Smith & Nephew Medical Limited

K-Number K161289

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LLZ 2016-08-03

JointPoint

Applicant Jointpoint, Inc.

K-Number K160284

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KNW 2016-08-03

CASSI II Rotational Core Biopsy System

Applicant Scion Medical Technologies, LLC

K-Number K161234

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BWF 2016-08-03

iPEP System and vPEP

Applicant D R Burton Healthcare, LLC

K-Number K160636

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EMA 2016-08-03

IonoStar Plus

Applicant Voco GmbH

K-Number K160774

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DXT 2016-08-03

DyeVert NG Contrast Modulation System

Applicant Osprey Medical, Inc.

K-Number K161505

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DZE 2016-08-03

IMMEDIATELOAD Dental Implant System

Applicant Immediateload S.A.

K-Number K151757

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HRS 2016-08-02

ARIX Foot System

Applicant Jeil Medical Corporation

K-Number K161864

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LZA 2016-08-02

Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim

Applicant Kossan International Sdn Bhd

K-Number K160467

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KNW 2016-08-02

M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem

Applicant Mermaid Medical A/S

K-Number K161409

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HRS 2016-08-02

Biomet Microfixation Sternal Closure System

Applicant Biomet Microfixation

K-Number K161896

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