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

OZE 2019-04-22

FluChip-8G Influenza A+B Assay

Applicant Indevr, Inc.

K-Number K182513

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PKC 2019-04-22

Comprehensive Nano Stemless Shoulder

Applicant Biomet Manufacturing Corp

K-Number K182516

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EBF 2019-04-22

LC GLOSSFILL XR

Applicant S&C Polymer Silicon- Und Composite Spezialitaeten GmbH

K-Number K182778

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DSY 2019-04-22

exGraft, exGraft Carbon

Applicant Peca Labs

K-Number K183613

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HRS 2019-04-19

ATLAS Plating System

Applicant MiRus, LLC

K-Number K190415

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PMN 2019-04-19

Cepheid Xpert C. difficile/Epi Control Panel

Applicant Microbiologics, Inc.

K-Number K190463

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QFC 2019-04-19

PREVENA 125 and PREVENA PLUS 125 Therapy Units

Applicant Kci USA, Inc.

K-Number DEN180013

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QGL 2019-04-19

Monarch eTNS System

Applicant Neurosigma, Inc.

K-Number DEN180041

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EBZ 2019-04-19

FUSION Plus Curing Light

Applicant Dentlight, Inc.

K-Number K180065

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NEZ 2019-04-19

CapsoCam Plus (SV-3)

Applicant CapsoVision, Inc.

K-Number K183192

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QGK 2019-04-19

Relieva Tract Balloon Dilation System

Applicant Acclarent, Inc.

K-Number K183090

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PLC 2019-04-19

OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor

Applicant Mark Abramson, D.D.S., Inc.

K-Number K181571

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