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

NUH 2018-11-21

PlayMakar Sport Muscle Stimulator, Model PRO-500

Applicant Playmakar, Inc.

K-Number K182581

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FMZ 2018-11-21

Isolette 8000 Plus

Applicant Draeger Medical Systems, Inc.

K-Number K182977

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LJS 2018-11-21

Jet Power Injectable PICC

Applicant Jet Medical, Inc.

K-Number K180546

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GCJ 2018-11-21

PINPOINT Endoscopic Fluorescence Imaging System

Applicant Novadaq Technologies Ulc. (Now A Part of Stryker)

K-Number K182606

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LLZ 2018-11-21

ProFuse CAD

Applicant Eigen

K-Number K173744

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DJR 2018-11-21

ARK EDDP Assay

Applicant Ark Diagnostics, Inc.

K-Number K182779

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FDI 2018-11-21

Roth Net Retriever Product Line

Applicant United States Endoscopy Group, Inc.

K-Number K182909

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MNR 2018-11-21

MATRx Plus

Applicant Zephyr Sleep Technologies

K-Number K181996

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LPL 2018-11-21

DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES AquaComfort Plus Multifocal

Applicant Alcon Laboratories, Inc.

K-Number K181454

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NUC 2018-11-21

Wet Organics Personal Lubricant

Applicant Trigg Laboratories Dba Wet International

K-Number K182027

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MUH 2018-11-21

DENTIOIII series (DENTIOIII, DENTIOIII-S)

Applicant Hdx Will Corp.

K-Number K181297

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IYN 2018-11-21

Versana Premier

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K182277

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