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

FED 2016-03-31

Proxis Ureteral Access Sheath

Applicant C.R. Bard, Inc.

K-Number K160861

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PLB 2016-03-31

T3 Software

Applicant Etiometry, Inc.

K-Number K152258

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DKZ 2016-03-31

AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)

Applicant Assure Tech. (Hangzhou) Co, Ltd.

K-Number K153465

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NGX 2016-03-31

Revitive Medic; Revitive MV; Revitive LV

Applicant Actegy , Ltd.

K-Number K152480

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FLL 2016-03-31

Infrared Ear Thermometer

Applicant Sejoy Electronics & Instruments Co., Ltd.

K-Number K153146

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KGO 2016-03-31

SensiCare PI Surgical Gloves

Applicant Medline Industries, Inc.

K-Number K152428

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MEH 2016-03-31

Corin TriFit TS Hip

Applicant Corin U.S.A. Limited

K-Number K153772

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HAW 2016-03-30

BrightMatter Guide with Surface Trace Registration

Applicant Synaptive Medical, Inc.

K-Number K153281

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NAY 2016-03-30

da Vinci Surgical System, Model IS4000

Applicant Intuitive Surgical, Inc.

K-Number K152578

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ILY 2016-03-30

Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)

Applicant In Light Wellness Systems, Inc.

K-Number K153389

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MHX 2016-03-30

AVIVO Mobile Patient Management (MPM) System

Applicant Medtronic, Inc.

K-Number K153160

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FDI 2016-03-30

Rotatable Snares

Applicant Boston Scientific Corporation

K-Number K160637

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