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

IYE 2016-09-16

DoseCHECK

Applicant Sun Nuclear Corporation

K-Number K161946

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EIH 2016-09-15

Luminesse Shaded Zirconia SZ

Applicant Talladium, Inc.

K-Number K152023

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EMB 2016-09-15

Provicol QM Plus

Applicant Voco GmbH

K-Number K161630

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DXJ 2016-09-15

CARESCAPE Central Station V2

Applicant GE Healthcare

K-Number K162012

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MAX 2016-09-15

PROW FUSION-L

Applicant Nlt Spine, Ltd.

K-Number K153665

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LYX 2016-09-15

Eusol-C

Applicant Al.Chi.Mi.A. S.R.L

K-Number K162013

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KNT 2016-09-15

CORGRIP NG/NI Tube Retention System

Applicant Corpak Medsystems, Inc. A Division of Haylard Health

K-Number K162110

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NHA 2016-09-15

Dentium Implantium & SuperLine Prosthetics

Applicant Dentium Co., Ltd.

K-Number K160828

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LEJ 2016-09-15

KBL Sunlamp Products (= Device Bundling name)

Applicant Kbl AG

K-Number K151962

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GEI 2016-09-15

PhotonBlade

Applicant Invuity, Inc.

K-Number K162053

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NCX 2016-09-15

TEMPEDY

Applicant Seiratherm GmbH

K-Number K152946

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GEI 2016-09-15

LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated

Applicant Covidien

K-Number K162047

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