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

NFO 2016-03-23

RejuvatoneMD

Applicant Trophy Skin, Inc.

K-Number K152199

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GEI 2016-03-23

Vesalius

Applicant Telea Electronic Engineering Srl

K-Number K152933

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OOK 2016-03-23

ZELTIQ CoolSculpting System

Applicant Zeltiq Aesthetics, Inc.

K-Number K160259

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DZE 2016-03-23

Straumann Bone Level Tapered Implants

Applicant Institut Straumann AG

K-Number K153758

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HRY 2016-03-23

MPO Total Knee Systems MR Labeling

Applicant Microport Orthopedics, Inc.

K-Number K152631

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FLL 2016-03-23

VDT985US Vicks SmartTemp Thermometer

Applicant Kaz USA, Inc., A Helen of Troy Company

K-Number K152975

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PNE 2016-03-23

Reprocessed Steerable Introducer

Applicant Sterilmed, Inc.

K-Number K152090

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PGW 2016-03-23

PointerShell Universal, PointerShell LS

Applicant Fiagon GmbH

K-Number K160479

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PCH 2016-03-22

Great Basin Shiga Toxin Direct Test

Applicant Great Basin Scientific, Inc.

K-Number K152955

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FCG 2016-03-22

Single Use Aspiration Needle NA-U401SX

Applicant Olympus Medical Systems Corp.

K-Number K160098

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LQD 2016-03-22

QbCheck

Applicant Qbtech AB

K-Number K143468

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GEH 2016-03-22

cryoFORM cryoICE cryoablation probe

Applicant AtriCure, Inc.

K-Number K152337

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