13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102435·NAGAHARA PHACO CHOPPER
NIVATOPIC PLUS
FDA 510(k)
FDA Unclassified
·Unknown
SA 9900 PLUS DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
IMP,TSV,4.1MM,SBM,11.5
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·March 7, 2022
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·March 7, 2022
CADD MEDICATION CASSETTES
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FPA·July 11, 2022
CADD MEDICATION CASSETTES
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FPA·July 11, 2022
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·October 23, 2014
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDIC INC, 1818910·Product code KWA·August 18, 2011
QUANTA SYSTEM S.P.A.
FDA Adverse Event
Malfunction
·QUANTA SYSTEM, S.P.A.·Product code GEX·December 21, 2012
NAGAHARA PHACO CHOPPER
FDA Adverse Event
Malfunction
·KATENA PRODUCTS INC.·Product code HND·September 19, 2022
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025