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

NPR 2018-01-12

cobas Factor II and Factor V Test

Applicant Roche Molecular Systems, Inc.

K-Number K172913

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LLZ 2018-01-12

Illumeo System

Applicant Philips Medical Systems Technologies , Ltd.

K-Number K173588

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KMF 2018-01-12

Aleo BME Liquid Bandage

Applicant Aleo Bme, Inc.

K-Number K171148

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LNH 2018-01-11

ECHELON OVAL V6.0A MRI System

Applicant Hitachi Healthcare Americas Corporation

K-Number K172110

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MRG 2018-01-11

Diazyme EZ Vitamin D Assay

Applicant Diazyme Laboratories

K-Number K172992

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PHX 2018-01-11

GLOBAL UNITE Platform Shoulder System

Applicant Depuy Ireland UC

K-Number K170748

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PNN 2018-01-11

CEREC Ortho Software

Applicant Dentsply Sirona

K-Number K171122

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NHA 2018-01-11

Dentium Ti-Base

Applicant Dentium Co., Ltd.

K-Number K171622

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ODG 2018-01-11

FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M

Applicant Fujifilm Medical Systems U.S.A, Inc.

K-Number K171207

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JDR 2018-01-11

ExoToe Staple

Applicant Exotoe, LLC

K-Number K172205

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JOM 2018-01-11

Automated ankle brachial pressure index measuring device

Applicant Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.

K-Number K172655

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NHA 2018-01-11

ET Hybrid Abutment

Applicant Hiossen, Inc.

K-Number K170421

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