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

PDQ 2018-03-22

SENTIO MMG Pedicle Access Needles

Applicant Medos International SARL

K-Number K173134

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NEU 2018-03-22

Tumark Vision

Applicant Somatex Medical Technologies GmbH

K-Number K180443

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ODC 2018-03-22

Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter

Applicant Cook Incorporated

K-Number K173105

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LQD 2018-03-22

Test of Variables of Attention (T.O.V.A.)

Applicant The Tova Company

K-Number K173915

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GJT 2018-03-22

HemosIL Factor XII Deficient Plasma

Applicant Instrumentation Laboratory CO

K-Number K180486

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PHX 2018-03-22

Arthrex UNIVERS REVERS COATED BASEPLATE

Applicant Arthrex, Inc.

K-Number K172371

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DFC 2018-03-22

Diazyme Lipoprotein (a) Assay

Applicant Diazyme Laboratories, Inc.

K-Number K180074

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DWF 2018-03-22

Bio-Medicus Adult Cannulae Kit

Applicant Medtronic, Inc.

K-Number K180456

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MAX 2018-03-22

Cortina [MAX] Lumbar Cage System

Applicant Neurostructures, Inc.

K-Number K180431

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ODP 2018-03-22

Alamo® C

Applicant Alliance Partners, LLC

K-Number K173128

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PQZ 2018-03-22

Granada Medium

Applicant Hardy Diagnostics

K-Number K173903

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DWF 2018-03-22

Bio-Medicus Adult Cannulae and Introducer

Applicant Medtronic, Inc.

K-Number K180453

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