6 results
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70ms
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Sources: EU EUDAMED, US FDA
Spectre Wireless Footswitch/Handswitch system Model 98/99, Model FDS, Model FDB. The Spectre Wireless Encrypted Footswitch/Hand Switch System is a prescription use system and intended only for use with the system indicated in the model number
FDA Recall
Terminated
·Trans American Medical, Inc.·Product code IZL·August 22, 2013
TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·May 31, 2021
Spectre Wireless Footswitch/Handswitch system Model 98/99, Model FDS, Model FDB. The Spectre Wireless Encrypted Footswitch/Hand Switch System is a prescription use system and intended only for use with the system indicated in the model number
FDA Enforcement
Class II
·Terminated·Trans American Medical, Inc.·January 15, 2014
mdi Europa GmbH
Authorized representative
🇩🇪 Germany·132 Manufacturers·4741 Devices
PRIM, S.A.
Importer
🇪🇸 Spain·64 Manufacturers
MedPath GmbH
Authorized representative
🇩🇪 Germany·537 Manufacturers·13464 Devices