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

OBO 2019-02-15

CIRRUS HD-OCT

Applicant Carl Zeiss Meditec, Inc.

K-Number K181534

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KWS 2019-02-15

ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)

Applicant Stryker GmbH

K-Number K183039

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FFX 2019-02-15

EndoFLIP System

Applicant Crospon, Ltd.

K-Number K183072

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MAX 2019-02-15

Reliance Lumbar IBF System

Applicant Reliance Medical Systems, LLC

K-Number K183049

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JWY 2019-02-15

Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mL

Applicant Thermo Fisher Scientific

K-Number K183324

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LNH 2019-02-15

MAGNETOM Aera

Applicant Siemens Medical Solutions USA, Inc.

K-Number K190138

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LNH 2019-02-15

MAGNETOM Terra

Applicant Siemens Medical Solutions USA, Inc.

K-Number K183222

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QBJ 2019-02-14

Dexcom G6 Continuous Glucose Monitoring System

Applicant Dexcom, Inc.

K-Number K183206

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HWC 2019-02-14

DynaNail Mini

Applicant MedShape, Inc.

K-Number K182677

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LNH 2019-02-14

Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems

Applicant Philips Medical Systems Nederland B.V.

K-Number K183063

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OLO 2019-02-14

Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker

Applicant Stryker Corporation

K-Number K183196

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FRO 2019-02-14

Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing

Applicant Winner Medical Co., Ltd.

K-Number K181315

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