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

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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FED 2016-03-31

Proxis Ureteral Access Sheath

Applicant C.R. Bard, Inc.

K-Number K160861

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PLB 2016-03-31

T3 Software

Applicant Etiometry, Inc.

K-Number K152258

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DKZ 2016-03-31

AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)

Applicant Assure Tech. (Hangzhou) Co, Ltd.

K-Number K153465

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NGX 2016-03-31

Revitive Medic; Revitive MV; Revitive LV

Applicant Actegy , Ltd.

K-Number K152480

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FLL 2016-03-31

Infrared Ear Thermometer

Applicant Sejoy Electronics & Instruments Co., Ltd.

K-Number K153146

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KGO 2016-03-31

SensiCare PI Surgical Gloves

Applicant Medline Industries, Inc.

K-Number K152428

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