9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SpaceFlex Acetabular Cup
FDA 510(k)
FDA Class 2
·Orthopedic
STRYKER CROSSFLOW ARTHROSCOPY PUMP
FDA 510(k)
FDA Class 2
·Orthopedic
PHILIPS MULTIDIAGNOST ELEVA
FDA 510(k)
FDA Class 2
·Radiology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 4, 2014
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·June 17, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 12, 2013
ZERO-P VA CAGE LORDOTIC H8 PEEK
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code OVE·July 16, 2020
ZERO-P VA CAGE LORDOTIC H8 PEEK
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code OVE·July 16, 2020
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026