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

PNZ 2016-09-16

Acclarent Aera Eustachian Tube Balloon Dilation System

Applicant Acclarent, Inc.

K-Number DEN150056

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LLZ 2016-09-16

JiveX

Applicant Visus Technology Transfer GmbH

K-Number K162008

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CAC 2016-09-16

CATSmart

Applicant Fresenius Kabi AG

K-Number K160735

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NHA 2016-09-16

Neodent Implant System - Titanium Base for CEREC

Applicant Jjgc Industria E Comercio DE Materiais Dentarios S.A.

K-Number K160964

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MOS 2016-09-16

TRILLIUM Oval Head Coil 32

Applicant Hitachi Medical Systems America, Inc.

K-Number K162079

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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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