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

JFY 2016-03-07

URITEK TC-201 URINE CHEMISTRY TEST SYSTEM

Applicant Teco Diagnostics, Inc.

K-Number K152835

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OWB 2016-03-07

Cios Fusion

Applicant Siemens Medical Solutions USA, Inc.

K-Number K153244

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BSO 2016-03-07

Medline Epidural Catheter

Applicant Medline Industries, Inc.

K-Number K150731

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JWH 2016-03-07

iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System

Applicant Conformis, Inc.

K-Number K160025

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GGN 2016-03-06

VisuCon-F Low Fibrinogen Control Plasma

Applicant Affinity Biologicals, Inc.

K-Number K150144

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DWF 2016-03-04

PROTEK Duo 31 Fr. Veno-Venous Cannula Set

Applicant Cardiacassist, Inc.

K-Number K160257

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NHA 2016-03-04

Straumann RN Gold Abutment for Bridge

Applicant Straumann USA, LLC

K-Number K151590

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ITX 2016-03-04

Sheathes Ultrasound Probe Covers

Applicant Sheathing Technologies, Inc.

K-Number K153212

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LPL 2016-03-04

SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens

Applicant Smart Performer Corp. , Ltd.

K-Number K151847

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LFL 2016-03-04

HARMONIC HOOK

Applicant Ethicon Endo-Surgery, LLC

K-Number K151136

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ELW 2016-03-04

Aquasil Ultra + Smart Wetting Impression Material

Applicant Dentply International, Inc.

K-Number K152861

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PLZ 2016-03-04

SENSIMED TRIGGERFISH

Applicant Sensimed AG

K-Number DEN140017

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