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

PLP 2016-12-21

Sonablate

Applicant Sonacare Medical, LLC

K-Number K160942

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MCW 2016-12-21

Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled

Applicant Avinger, Inc.

K-Number K163264

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OCC 2016-12-21

Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument

Applicant Alere Scarborough, Inc.

K-Number K163266

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PQH 2016-12-21

ulrich Transfer Set

Applicant Ulrich GmbH & Co. KG

K-Number K161723

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MUD 2016-12-21

Ox-Imager CS

Applicant Modulated Imaging, Inc.

K-Number K153426

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CFF 2016-12-21

CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL

Applicant Sebia

K-Number K161928

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BSK 2016-12-21

TRACOE Cuff Pressure Monitor

Applicant Tracoe Medical GmbH

K-Number K152778

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KCT 2016-12-20

K3PRO SURGICAL TRAY

Applicant Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG

K-Number K160574

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NUH 2016-12-20

CP Relief Wand-OTC

Applicant Mid-America Medical Innovations, LLC

K-Number K162630

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NKB 2016-12-20

CD HORIZON® Spinal System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K163301

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FTM 2016-12-20

Endoform Plastics and Reconstructive Matrix

Applicant Aroa Biosurgery (Formerly Mesynthes Limited)

K-Number K162461

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PML 2016-12-20

CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems

Applicant Medos International Sàrl

K-Number K160879

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