13 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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N-HYBRIDE-COMPOSITE LC FLOW
FDA 510(k)
FDA Class 2
·Dental
ISOBAR SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MIRAGE MICRO
FDA 510(k)
FDA Class 2
·Anesthesiology
PAGEWRITER TC 20 CARDIOGRAPH
FDA Adverse Event
Malfunction
·PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC·Product code DPS·May 17, 2021
LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTT·October 19, 2012
LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTT·October 19, 2012
LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTT·October 19, 2012
LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTT·October 19, 2012
CUP: VERSAFITCUP ACETABULAR SHELL Ø 46
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·December 7, 2018
PENROSE
FDA Adverse Event
Malfunction
·BARD MEDICAL·Product code GCY·April 29, 2013
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014
NEXGEN STEMMED TIBIAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER·Product code JWH·May 31, 2011
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021