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

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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CDZ 2016-02-11

Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K151529

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LPL 2016-02-11

Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist

Applicant Bausch & Lomb, Incorporated

K-Number K151918

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PMS 2016-02-11

ivWatch Model 400

Applicant Ivwatch, LLC

K-Number K153605

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