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

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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FMI 2018-03-21

DROPLET PEN NEEDLE

Applicant Htl-Strefa S.A

K-Number K171982

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GEH 2018-03-21

Freezpoint

Applicant Bovie Medical Corp.

K-Number K180211

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LLZ 2018-03-21

Emprint Ablation Visualization Application

Applicant Covidien, LLC

K-Number K180192

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LLZ 2018-03-21

WillCeph

Applicant Hdx Will Corp.

K-Number K172168

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OAP 2018-03-21

DermaScalp Laser Cap

Applicant Dermascalp, LLC

K-Number K173846

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MUE 2018-03-21

Mammomat Revelation

Applicant Siemens Medi Cal Solutions, Inc.

K-Number K173408

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