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

LNH 2016-07-08

S-scan

Applicant Esaote, S.p.A.

K-Number K161238

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FMF 2016-07-08

BD U-500 INSULIN SYRINGE

Applicant Becton, Dickinson and Company

K-Number K151870

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ILY 2016-07-08

The Time Machine Series Lasers

Applicant Medical Lasers Manufacturer, Inc.

K-Number K152461

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GEI 2016-07-08

PlasmaBlade TnA Tonsil and Adenoid Dissection Device

Applicant Medtronic Advanced Energy

K-Number K152703

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OHT 2016-07-08

sensiLight Mini

Applicant El Global Trade, Ltd.

K-Number K161089

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JGS 2016-07-08

i-STAT Alinity System with i-STAT Sodium test

Applicant Abbott Point of Care, Inc.

K-Number K153357

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OHV 2016-07-08

ULTRASHAPE POWER SYSTEM

Applicant Syneron Medical, Ltd.

K-Number K160896

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NKB 2016-07-08

Savannah-T® Pedicle Screw System

Applicant Amendia, Inc.

K-Number K152920

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LCO 2016-07-08

HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls

Applicant Instrumentation Laboratory CO

K-Number K153137

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FMF 2016-07-08

LITe BIO Delivery System

Applicant Stryker Corporation

K-Number K160978

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OYH 2016-07-08

AcceleDent Aura

Applicant Orthoaccel Technologies, Inc.

K-Number K153048

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OVE 2016-07-08

Alta ACDF System

Applicant Biomet Spine

K-Number K152622

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