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

PIF 2017-03-17

Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector

Applicant Trovrx, Inc. Dba Trovita Health Science

K-Number K163586

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KLE 2017-03-17

RnD TE and RnD SE

Applicant Apex Dental Materials, Inc.

K-Number K161077

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DTN 2017-03-17

Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface

Applicant Medtronic, Inc.

K-Number K170583

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HRS 2017-03-17

Olecranon Plating System

Applicant Miami Device Solutions, LLC

K-Number K162898

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EFA 2017-03-17

SMARTmatic

Applicant Kaltenbach & Voigt GmbH

K-Number K163239

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DWJ 2017-03-17

OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY

Applicant Bcg Medical, LLC

K-Number K162562

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LNH 2017-03-17

Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist

Applicant Ge Medical Systems, LLC

K-Number K163331

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DXN 2017-03-17

Consult Station TS

Applicant H4D Sas

K-Number K153600

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BYI 2017-03-17

Monarch Airway Clearance System

Applicant Hill-Rom Services Pte, Ltd.

K-Number K163378

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LFZ 2017-03-17

Elecsys CMV IgM

Applicant Roche Diagnostics

K-Number K163569

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LLZ 2017-03-17

Exam Vue PACS

Applicant Jpi Healthcare Solutions, Inc.

K-Number K162868

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EBF 2017-03-17

MAZIC Duro

Applicant Vericom Co., Ltd.

K-Number K163346

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