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

GEX 2019-08-30

LightWalker Laser System Family

Applicant Fotona D.O.O.

K-Number K191554

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QHE 2019-08-30

Signature ONE System

Applicant Orthosoft Inc (D/B/A Zimmer Cas)

K-Number K192074

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MAX 2019-08-30

Triton Cage

Applicant Medyssey USA, Inc.

K-Number K183407

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FET 2019-08-30

Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head

Applicant Olympus Medical Systems Corp.

K-Number K190449

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GZJ 2019-08-30

ReliefBand

Applicant Reliefband Technologies, LLC

K-Number K191547

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CEW 2019-08-30

Lumipulse G whole PTH

Applicant Fujirebio Diagnostics,Inc.

K-Number K190702

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KWQ 2019-08-30

Cyclops Anterior Cervical Plate System

Applicant Degen Medical, Inc.

K-Number K191786

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LPH 2019-08-30

iNSitu Total Hip System

Applicant Theken Companies, LLC

K-Number K192071

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HGX 2019-08-30

OPERA, OPERA eco

Applicant Unimom.Co

K-Number K190810

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DQY 2019-08-30

SelectFlex 072 Neurovascular Access System

Applicant Q'Apel Medical

K-Number K191664

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DSH 2019-08-30

Carnation Ambulatory Monitor

Applicant Bardy Diagnostics, Inc.

K-Number K191471

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DXN 2019-08-30

EV1000 Clinical Platform NI, EV1000 Clinical Platform

Applicant Edwards Lifesciences, LLC

K-Number K192058

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