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

JKA 2017-02-09

PIVO

Applicant Velano Vascular

K-Number K163508

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KNT 2017-02-09

Low Profile Balloon Feeding Device

Applicant Applied Medical Technology, Inc.

K-Number K161413

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OCC 2017-02-09

Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System

Applicant Cepheid

K-Number K162331

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JAK 2017-02-09

syngo.CT Extended Functionality

Applicant Siemens Medical Solutions USA, Inc.

K-Number K163341

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HWC 2017-02-09

RASL Repair Kit

Applicant Radicle Orthopaedics, Inc.

K-Number K161334

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LSL 2017-02-09

cobas® CT/NG v2.0 Test

Applicant Roche Molecular Systems, Inc.

K-Number K163184

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HRS 2017-02-09

APTUS® Coronoid 2.0

Applicant Medartis AG

K-Number K161861

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LZA 2017-02-08

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)

Applicant Hartalega Sdn Bhd

K-Number K162491

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NFJ 2017-02-08

OptosAdvance 4.0 Software

Applicant Optos Plc.

K-Number K162039

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DXN 2017-02-08

Fully Automatic Electronic Blood Pressure Monitor

Applicant Andon Health Co, Ltd.

K-Number K162915

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KGO 2017-02-08

Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove

Applicant Lucenxia Prescience AG

K-Number K162852

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KDI 2017-02-08

FB-U Hemodialyzer

Applicant Nipro Medical Corporation

K-Number K160444

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