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

DQX 2017-08-21

Approach CTO Microwire Guide

Applicant Cook Incorporated

K-Number K171897

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NKB 2017-08-21

Zenius, lliad and Kora Spinal Fixation Systems

Applicant Medyssey USA, Inc.

K-Number K171526

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FEO 2017-08-21

ShockPulse-SE Lithotripsy System

Applicant Cybersonics, Inc.

K-Number K171024

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NKB 2017-08-21

Threshold V2 Pedicular Fixation System, Threshold Pedicular Fixation System, Fortress Pedicular Fixation System, Palisade Pedicular Fixation System

Applicant Spineology, Inc.

K-Number K172107

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NKG 2017-08-21

INFINITY OCT System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K163375

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KGO 2017-08-21

Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs

Applicant Tg Medical Sdn. Bhd.

K-Number K171276

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DQY 2017-08-21

MAMBA and MAMBA FLEX Microcatheters

Applicant Boston Scientific Corporation

K-Number K171452

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FRO 2017-08-21

Sorbact Wound Dressing-Ribbon Gauze

Applicant Abigo Medical AB

K-Number K171225

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GXY 2017-08-21

Ceribell Instant EEG Headband

Applicant Ceribell, Inc.

K-Number K171459

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PIQ 2017-08-21

RIDA GENE Norovirus GI/GII

Applicant R-Biopharm AG

K-Number K171511

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DXT 2017-08-18

CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip

Applicant Coeur, Inc.

K-Number K170431

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GEX 2017-08-18

StarWalker

Applicant Fotona D.O.O.

K-Number K171227

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