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

NKB 2016-02-12

Adena-Zina System

Applicant Shanghai Sanyou Medical Co, Ltd.

K-Number K152781

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MWI 2016-02-12

Masimo Root Vital Signs Monitoring System and Accessories

Applicant Masimo Corporation

K-Number K151644

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JAK 2016-02-12

Clear Guide SCENERGY

Applicant Clear Guide Medical

K-Number K153004

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DXN 2016-02-12

Microlife Upper Arm Automatic Digital Blood Pressure Monitor

Applicant Microlife Intellectual Property GmbH

K-Number K153077

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DYB 2016-02-12

PTFE Super Sheath Introducer 2.1

Applicant Medcomp (Medical Components, Inc.)

K-Number K153246

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FBK 2016-02-12

Single Use Injector NM600/610

Applicant Olympus Medical Systems Corp.

K-Number K153625

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JKA 2016-02-12

BD Vacutainer UltraTouch Push Button Blood Collection Set

Applicant Becton, Dickinson and Company

K-Number K153309

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GEX 2016-02-12

Spirit Hair Removal laser Family

Applicant Active Optical Systems , Ltd.

K-Number K153718

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LLZ 2016-02-12

CARESTREAM Vue PACS

Applicant Carestream Health, Inc.

K-Number K153103

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MQV 2016-02-12

Vitoss BiModal Bone Graft Substitute Foam Strip

Applicant Orthovita, Inc.

K-Number K153608

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NUH 2016-02-12

Pain Therapy System, Model PTS-II

Applicant Counter Scientific Development (Gz), Ltd.

K-Number K150277

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CDZ 2016-02-11

ARCHITECT SHBG

Applicant Biokit, S.A.

K-Number K152185

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