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

FMI 2016-03-07

MEDT PEN NEEDLE

Applicant Shandong Caremed Medical Products Co., Ltd.

K-Number K152824

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MAX 2016-03-07

PERIMETER Interbody Fusion Device

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K160418

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KRD 2016-03-07

Bead Block

Applicant Biocompatibles UK , Ltd.

K-Number K150876

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GEI 2016-03-07

Cobbra RF Tissue Dissector

Applicant Elliquence, LLC

K-Number K160041

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DYB 2016-03-07

Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select

Applicant Cook Incorporated

K-Number K153430

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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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