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

PHX 2017-02-21

SMR TT Metal Back Glenoid, Bone Graft instruments

Applicant Lima Corporate S.P.A.

K-Number K161120

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EBW 2017-02-21

ELECTROmatic

Applicant Kaltenbach & Voigt Gmgh

K-Number K163317

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HRS 2017-02-21

AlignMATE Lapidus Arthrodesis System

Applicant Arthrosurface, Inc.

K-Number K162391

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PCU 2017-02-18

AXIOS Stent and Electrocautery Enhanced Delivery System

Applicant Boston Scientific Corporation

K-Number K163272

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DQY 2017-02-18

VIA 17 Microcatheter

Applicant Sequent Medical, Inc.

K-Number K162565

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BWC 2017-02-17

Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set

Applicant Cook Incorporated

K-Number K160200

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LTF 2017-02-17

GenNarino

Applicant Saliwell , Ltd.

K-Number K160799

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LCP 2017-02-17

CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)

Applicant Sebia

K-Number K162281

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HRX 2017-02-17

Intra medullary endo-transilluminating device (iMET device)

Applicant WeMED Bio-Tech, Inc.

K-Number K163037

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GAT 2017-02-17

ExpressBraid Graft Manipulation

Applicant Biomet Manufacturing Corp

K-Number K163651

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PRK 2017-02-17

ReDe Mask

Applicant Tereopneuma

K-Number K161953

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MOD 2017-02-17

Care Cycle Connect Application

Applicant Respironics, Inc.

K-Number K161411

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