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

PGW 2016-02-18

Fusion Compact Navigation System

Applicant Medtronic Navigation, Inc.

K-Number K153247

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NHN 2016-02-18

Erchonia EVRL

Applicant Erchonia Corporation

K-Number K152196

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KGE 2016-02-18

Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)

Applicant Fujifilm Medical System U.S.A., Inc.

K-Number K151474

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MMX 2016-02-18

Recovery Cone Removal System

Applicant C.R. Bard, Inc.

K-Number K152136

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LLZ 2016-02-17

CliniscanSM MRI

Applicant Picofemto, LLC

K-Number K153593

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CEC 2016-02-17

FREND™ Free T4 Test System

Applicant Nanoentek USA, Inc.

K-Number K152422

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MTJ 2016-02-17

ROP Resorbable Hemostasis Material

Applicant Resorbable Orthopedic Products, LLC

K-Number K153095

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GAR 2016-02-17

Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture

Applicant Aesculap, Inc.

K-Number K151165

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JIT 2016-02-17

ST AIA-PACK hsE2 Calibrator Set

Applicant Tosoh Bioscience, Inc.

K-Number K160113

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IPF 2016-02-17

VitalStim(R) Plus Electrotherapy System

Applicant Djo, LLC

K-Number K153224

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JFM 2016-02-16

Direct Bilirubin

Applicant Randox Laboratories Limited

K-Number K152343

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KTT 2016-02-16

D.N.E. External Fixation System

Applicant Dne, LLC

K-Number K151580

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