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

NKB 2016-06-10

Arsenal Spinal Fixation System

Applicant Alphatec Spine, Inc.

K-Number K161363

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JWH 2016-06-10

ATTUNE Revision Knee System

Applicant Depuy(Ireland)

K-Number K160700

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CCL 2016-06-10

MaxO2ME

Applicant Maxtec, LLC

K-Number K153659

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KWS 2016-06-10

Aequalis PerFORM+ Shoulder System

Applicant Tornier, Inc.

K-Number K160975

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KWS 2016-06-10

BLUEPRINT Patient Specific Instrumentation

Applicant Tornier S.A.S.

K-Number K160555

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OBP 2016-06-10

NeuroStar TMS Therapy System

Applicant Neuronetics, Inc.

K-Number K160703

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NHV 2016-06-10

Pall-Aquasafe Water Filter

Applicant Pall International Sarl

K-Number K153434

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ERL 2016-06-10

DIEGO ELITE DRILL

Applicant Gyrus Acmi, Inc.

K-Number K152744

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FRO 2016-06-10

Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23oz

Applicant Simple Science, LLC

K-Number K160095

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CBI 2016-06-10

Endobronchial Tube

Applicant Henan Tuoren Medical Device Co., Ltd.

K-Number K152251

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FRC 2016-06-09

3M Attest Rapid Readout Biological Indicator

Applicant 3M Company

K-Number K160546

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MBI 2016-06-09

MILAGRO ADVANCE PEEK Interference Screw

Applicant Medos International SARL

K-Number K161001

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