150 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REDONDO-L
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814800·GENUMEDI EXTRA WIDE SILVER SIZE VII
Bernafon
FDA UDI
Bernafon AG·05711584003596·MD1 CP, VC PS BE MONDO 1
Allen Stifle Retractor
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896111363·Allen Stifle Retractor With Speed Lock
AIRCAST, MODEL #3011
FDA 510(k)
FDA Class 2
·Cardiovascular
MAMMOTOME HAND HELD PROBE, MODEL MHH8
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·February 25, 2020
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTL.·Product code MNI·October 14, 2011
RESUS BAG ADULT MANUAL 6/CS
FDA Adverse Event
Death
·CAREFUSION·Product code BTM·May 9, 2013
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 19, 2014
BAXTER STERILE WATER FOR IRRIGATION
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code LWD·May 20, 2011
KYPHON XPEDE BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·November 6, 2019
KYPHON XPEDE BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·July 30, 2019
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·April 2, 2019
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·April 2, 2019
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·January 9, 2020
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code MNI·November 11, 2011
ACTIVOS¿ BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·October 22, 2024
KYPHON XPEDE BONE CEMENT
FDA Adverse Event
Malfunction
·CARDIAC SURGERY MFG KERKRADE·Product code NDN·November 10, 2025
KYPHON XPEDE BONE CEMENT
FDA Adverse Event
Malfunction
·CARDIAC SURGERY MFG KERKRADE·Product code NDN·November 10, 2025