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

NZT 2017-06-01

OARtrac System with Patient Specific Reusable Universal PSD Sensors

Applicant Radiadyne, LLC

K-Number K162954

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KHS 2017-06-01

Carbon Dioxide Reagent Set

Applicant Teco Diagnostics, Inc.

K-Number K170200

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PRI 2017-06-01

ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls

Applicant Fisher Diagnostics

K-Number K170652

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GCJ 2017-06-01

Xenocor Xenoscope Laparoscopic System

Applicant Xenocor, Inc.

K-Number K171344

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DRE 2017-06-01

Medcomp Vessel Dilator

Applicant Medcomp ( Medical Components)

K-Number K162389

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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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