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

OWB 2016-02-10

Cios Select

Applicant Siemens Medical Solutions USA, Inc.

K-Number K153232

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FGA 2016-02-09

Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set

Applicant Schoelly Fiberoptic GmbH

K-Number K151308

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GEX 2016-02-09

DIODE LASER THERAPY SYSTEMS

Applicant Beijing Sincoheren Science and Tech. Development Co., Ltd.

K-Number K152898

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MPN 2016-02-09

Exofin High Viscosity Tissue Adhesive

Applicant Chemence Medical Products, Inc.

K-Number K152476

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GBM 2016-02-09

Actreen Mini Intermittent Urinary Catheters

Applicant B.Braun Medical, Inc.

K-Number K151772

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NEZ 2016-02-09

CapsoCam (SV-1)

Applicant CapsoVision, Inc.

K-Number K151635

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MWI 2016-02-09

Dictum Health

Applicant Dictum Health, Inc.

K-Number K152645

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LZA 2016-02-09

Powder Free Nitrile Patient Examination Gloves, Black color

Applicant Suqian Xingye Glove Co,Ltd

K-Number K152271

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OCX 2016-02-09

ENDOFLOW II - Irrigation, Warming and Suction System

Applicant Promepla Sam

K-Number K152278

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FLL 2016-02-09

Electronic Thermometer

Applicant Guangdong Biolight Meditech Co., Ltd.

K-Number K152739

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OAT 2016-02-09

OBS Anchorage Screw

Applicant Bomei Co, Ltd.

K-Number K152297

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PIO 2016-02-09

Nutrisafe 2- ENFit Adaptor

Applicant Vygon

K-Number K151237

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