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

ITX 2017-06-01

GTK Disposable Needle Guides

Applicant Geotek Medikal Ltd Sti

K-Number K170741

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KPS 2017-06-01

Biograph Horizon PET/CT

Applicant Siemens Medical Solutions USA, Inc.

K-Number K170904

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KPS 2017-06-01

Celesteion, PCA-9000A/3

Applicant Toshibamedical Systems Corporation

K-Number K170490

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JAQ 2017-06-01

System, Applicator, Radionuclide, Remote Controlled

Applicant Kobold, LLC

K-Number K170203

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JXI 2017-06-01

Reinforced Flexible Collagen Nerve Cuff

Applicant Collagen Matrix, Inc.

K-Number K170656

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LLZ 2017-06-01

syngo Dynamics Version VA30

Applicant Siemens Healthcare GmbH

K-Number K171053

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PHX 2017-06-01

ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System

Applicant Zimmer GmbH

K-Number K170711

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NHV 2017-06-01

Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)

Applicant Pall International Sarl

K-Number K163609

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IPF 2017-05-31

EMS100 Tri-Wave Combination Stimulator

Applicant Elite Medical Supply of New York, LLC

K-Number K171387

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HQD 2017-05-31

Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens

Applicant Acuity Polymers, Inc.

K-Number K170007

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GDW 2017-05-31

OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 Fasteners

Applicant C.R. Bard, Inc.

K-Number K170278

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GEX 2017-05-31

Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece

Applicant Alma Lasers, Inc.

K-Number K170626

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