8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDART 455 SCANNER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Polystar HK
FDA UDI
Merz Dental GmbH·D7091984339·anteriors; shade B3; mould Q 84
TORAY FILTRYZER DIALYZERS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DENTOMAT 3 AMALGAMATORS
FDA 510(k)
FDA Class 1
·Dental
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 28, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·August 6, 2014
U0109 ACCURA SYSTEM DISP SET
FDA Adverse Event
Malfunction
·HAEMOTRONIC·Product code KDI·February 10, 2011
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024