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

EMA 2019-04-25

PANAVIA SA Cement Universal

Applicant Kuraray Noritake Dental, Inc.

K-Number K183537

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NUC 2019-04-25

Smile Makers Personal Lubricant

Applicant Lfbeauty (Thailand) Limited

K-Number K182100

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PIF 2019-04-25

Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes

Applicant Cedic S.R.L.

K-Number K181787

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MBI 2019-04-24

Parcus ATLAS

Applicant Parcus Medical, LLC

K-Number K190375

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GEX 2019-04-24

V-Laser

Applicant Wontech Co., Ltd.

K-Number K183156

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HIH 2019-04-24

Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags

Applicant Corinth Medtech, Inc.

K-Number K190113

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MJN 2019-04-24

Occlusion Balloon Catheter

Applicant Qxmedical, LLC

K-Number K183679

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EBI 2019-04-24

Halley resin

Applicant Dentsply Sirona

K-Number K190043

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PUU 2019-04-24

Comaneci, Comaneci Petit, Comaneci 17

Applicant Rapid-Medical , Ltd.

K-Number DEN170064

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FYA 2019-04-24

Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora)

Applicant Medline Industries, Inc.

K-Number K182172

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OAS 2019-04-24

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS

Applicant Cefla S.C.

K-Number K190496

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JCX 2019-04-24

IntelliCartTM System

Applicant Dornoch Medical Systems

K-Number K190789

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