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

CBK 2019-07-26

Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented

Applicant Sleepnet Corporation

K-Number K190533

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MQL 2019-07-26

RapidVit Oocyte, RapidWarm Oocyte

Applicant Vitrolife Sweden AB

K-Number K183486

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FLL 2019-07-26

Infrared Ear/Forehead Thermometer

Applicant Joytech Healthcare Co. , Ltd.

K-Number K190873

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JAK 2019-07-26

AI-Rad Companion (Pulmonary)

Applicant Siemens Medical Solutions USA, Inc.

K-Number K183271

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PPT 2019-07-26

KLS Martin Individual Patient Solutions (IPS) Planning System

Applicant KLS-Martin L.P.

K-Number K182889

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JWH 2019-07-25

Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer

Applicant Osteoremedies, LLC

K-Number K183017

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DWM 2019-07-25

Passio Pump Drainage System

Applicant Bearpac Medical

K-Number K190292

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MXK 2019-07-25

Galilei G6 Lens Professional

Applicant Sis Ag, Surgical Instrument Systems

K-Number K182659

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KDI 2019-07-25

PrisMax System Version 2

Applicant Baxter Healthcare Corp

K-Number K190910

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LQR 2019-07-25

Stonetome Stone Removal Device

Applicant Boston Scientific Corporation

K-Number K191789

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NTE 2019-07-25

Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires

Applicant Abbott Vascular

K-Number K191173

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MBI 2019-07-25

RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant

Applicant Medos International SARL

K-Number K190774

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