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

NKB 2016-02-18

CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE Systems

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K153442

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JDI 2016-02-18

Alpine Cemented Hip System

Applicant Ortho Development Corporation

K-Number K153216

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OVD 2016-02-18

Optimus ALIF System

Applicant Amendia, Inc.

K-Number K160291

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MHX 2016-02-18

Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K152902

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JDR 2016-02-18

OS2-C Compression Staple

Applicant In2bones Sas

K-Number K153395

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GEI 2016-02-18

ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO)

Applicant Ent Biotech Solutions

K-Number K152702

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NGZ 2016-02-18

VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL

Applicant bioMerieux, Inc.

K-Number K151817

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EIE 2016-02-18

Triumph Resin Dam

Applicant Denali Corporation

K-Number K151945

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LLZ 2016-02-18

DBSWIN and VistaEasy Imaging Software

Applicant Durr Dental AG

K-Number K143290

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PGW 2016-02-18

Fusion Compact Navigation System

Applicant Medtronic Navigation, Inc.

K-Number K153247

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NHN 2016-02-18

Erchonia EVRL

Applicant Erchonia Corporation

K-Number K152196

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KGE 2016-02-18

Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)

Applicant Fujifilm Medical System U.S.A., Inc.

K-Number K151474

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