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

ISA 2018-04-13

D-Actor 200 Vibration Massage System

Applicant Storz Medical AG

K-Number K173692

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ELW 2018-04-13

Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono

Applicant Dreve Dentamid GmbH

K-Number K171562

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PKA 2018-04-13

Reza Band, Reflux Band

Applicant Somna Therapeutics, LLC

K-Number K173934

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DQX 2018-04-12

JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire

Applicant Boston Scientific

K-Number K180795

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CGN 2018-04-12

Atellica IM Folate Assay

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K172201

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LJS 2018-04-12

C3 Wave System

Applicant Medical Components, Inc. (dba MedComp)

K-Number K180567

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QSY 2018-04-12

StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing

Applicant Statguard, LLC

K-Number K172155

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MCW 2018-04-12

Straub Endovascular System

Applicant Straub Medical AG

K-Number K172315

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LLZ 2018-04-12

ZED Link

Applicant Zed Technologies

K-Number K180549

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JAA 2018-04-12

Uroview FD II

Applicant Pausch Medical GmbH

K-Number K180651

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MOS 2018-04-12

48CH Head Coil

Applicant Ge Healthcare Coils (Usa Instruments, Inc.)

K-Number K180666

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PKL 2018-04-12

Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device

Applicant STERIS Corporation

K-Number K180689

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