7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ZOLL X SERIES
FDA 510(k)
FDA Class 3
·Cardiovascular
MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4)
FDA 510(k)
FDA Class 1
·Ophthalmic
IUR RECIPROCATING MORCELLATOR MODEL # 7210517
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
LEVEEN NEEDLE ELECTRODE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code GEI·June 27, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 4, 2014
Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, Item # RBA203. Sterile EO. Microtek Medical, Inc., Columbus, MS 39702.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 14, 2016