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

LZA 2016-03-31

Halyard Black-Orange Powder-Free Nitrile Exam Glove

Applicant Halyard Health

K-Number K153708

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HRX 2016-03-31

Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing

Applicant Stryker Corporation

K-Number K151932

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LZA 2016-03-31

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU)

Applicant Hartalega NGC Sdn. Bhd.

K-Number K151997

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OAS 2016-03-31

NewTom VGi evo

Applicant Qr S.R.L.

K-Number K151612

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NHA 2016-03-31

Abutment for Bridges

Applicant Altatec GmbH

K-Number K153779

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LNH 2016-03-31

ECHELON Oval V 5.1 MRI System

Applicant Hitachi Medical Systems America, Inc.

K-Number K153547

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MAX 2016-03-31

Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System

Applicant Ldr Spine USA

K-Number K153495

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OWI 2016-03-31

JAZZ LOCK

Applicant Implanet, S.A.

K-Number K153348

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LNH 2016-03-31

MAGNETOM Spectra

Applicant Siemens Medical Solutions USA, Inc.

K-Number K153447

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IOR 2016-03-31

Pure Tilt

Applicant Proactive Comfort, LLC

K-Number K152021

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JWY 2016-03-31

Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL

Applicant Liofilchem s.r.l.

K-Number K153687

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KCT 2016-03-31

ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAY

Applicant Conmed Corporation

K-Number K152969

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