149 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM; AMSCO V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
JOBST Bella Strong
FDA UDI
BSN MEDICAL, INC.·00035664010386·BELLA STRONG 30-40 MM HG ARMSLEEVE DOT BAND SIZ...
JMS APHERESIS NEEDLE SET ACCORDION TYPE
FDA 510(k)
FDA Class 2
·General Hospital
ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINE
FDA 510(k)
FDA Class 2
·Anesthesiology
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·February 25, 2020
VERCISE CARTESIA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·May 24, 2023
RESTORE
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 9, 2013
SYMBIQ SCHANNEL 3.01
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·August 27, 2014
PULSE GEN MODEL 104
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·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
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
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
KYPHON® ACTIVOS¿ BONE CEMENT WITH HYDROXYAPATITE
FDA Adverse Event
Malfunction
·CARDIAC SURGERY MFG KERKRADE·Product code NDN·November 29, 2024
KYPHON® ACTIVOS¿ BONE CEMENT WITH HYDROXYAPATITE
FDA Adverse Event
Malfunction
·CARDIAC SURGERY MFG KERKRADE·Product code NDN·April 29, 2025