9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COZUMEL DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981505·anteriors; shade BL3; mould IM6
THERAGEM PROFESSIONAL T1002
FDA 510(k)
FDA Class 2
·Physical Medicine
V.A.C. DERMATAC Drape
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYNCHRON® ALT REAGENT, 2 X 200 TEST
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code CKA·July 26, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·February 27, 2013
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·August 5, 2014
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·January 12, 2011
SINGLE FUNCTION ABC PENCIL, HAND CONTROL HANDPIECE
FDA Adverse Event
Malfunction
·CONMED ELECTROSURGERY·Product code HAM·September 11, 2015