Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

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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MBI 2018-03-21

Ventix Link Knotless Anchor with Inserter

Applicant Cayenne Medical, Inc.

K-Number K180274

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LLZ 2018-03-21

Mimics inPrint

Applicant Materialise NV

K-Number K173619

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JAQ 2018-03-21

Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Sets, odd lengths and even lengths, Universal Titanium Cervix Probe Sets, odd lengths and even lengths

Applicant Varian Medical Systems, Inc.

K-Number K172611

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JAK 2018-03-21

SOMATOM Edge Plus

Applicant Siemens Medical Solutions USA, Inc.

K-Number K173607

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MOS 2018-03-21

P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil

Applicant Rapid Biomedical GmbH

K-Number K163661

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GXY 2018-03-21

Element System with IBT Electrodes

Applicant Infinite Biomedical Technologies, LLC

K-Number K173571

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