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Name Classification Manufacturer Risk Class Country Source
ISOMED Implantable Infusion Pumps (Mod. 8472-20, 8472-35, 8472-60) and SYNCHROMED II (Mod. 8637-20 and 8637-40). Anvisa registration number: 10099430095 (ISOMED) and 10099430103 (SYNCHROMED II). General Hospital and Personal Use Devices Medtronic Inc; Dabasons Imp. Exp. e Comércio Ltda Brazil ANVISA
MEDTRONIC IMPLANTABLE INFUSION PUMP. Models: SYNCHROMED II 8637-20 and 8637-40; SYNCHROMED EL 8626-10, 8626L-10, 8626-18, 8626L-18; SYNCHROMED EL 8627. Anvisa Registries No. 10339190229, 10339190104 and 10339190105. General Hospital and Personal Use Devices Medtronic Comercial Ltda. Brazil ANVISA
Implanted Infusion Pump Medtronic Technical Name: Synchromed II 8637-20 / Synchromed II 8637-40 ANVISA Registration Number: 10339190229 Hazard Class: IV Affected Model: 8637-20 and 8637-40 Serial Numbers Affected: PUMP 8637 -20 SM2 20ML EMAN US JUN BATRY; PUMP 8637-20 SM2 20ML PAP MAN US JUN BAT; PUMP 8637-20 SM2 20ML PAPER MAN USMKT SL; PUMP 8637-20 SM2 20ML PAPR MAN USMKTJUNC PUMP 8637-20 SYNCH II 20ML US MKT SL; PUMP 8637-20 SYNCHMED II 20ML PF; PUMP 8637-20 SYNCHMED II PCKT FILL L105; PUMP 8637-20 SYNCHROMED II L089; PUMP 8637-20 SYNCHROMED II OUS L105; PUMP 8637-40 SYNCHMED II PCKT FILL L105; PUMP 8637-40 SYNCHROMED II L089; PUMP 8637-40 SYNCHROMED II OUS L105. General Hospital and Personal Use Devices Medtronic Inc.; MEDTRONIC COMERCIAL LTDA Brazil ANVISA
implantable synchromed infusion pump General Hospital and Personal Use Devices Medtronic Poland ORMPMDBP
implantable synchromed infusion pumps. General Hospital and Personal Use Devices Medtronic Poland ORMPMDBP
model 8637 of implantable infusion pumps synchromed ii General Hospital and Personal Use Devices Medtronic Poland ORMPMDBP
software card update, model 8870, and synchromed infusion system labeling General Hospital and Personal Use Devices Medtronic Poland ORMPMDBP
SynchroMed EL; SynchroMed II; IsoMed General Hospital and Personal Use Devices Medtronic Poland ORMPMDBP
implantable synchromed® infusion pump General Hospital and Personal Use Devices Medtronic Poland ORMPMDBP
SYNCHROMED II - PROGRAMMABLE PUMP General Hospital and Personal Use Devices MEDTRONIC OF CANADA LTD. Canada HC
SYNCHROMED II - PROGRAMMABLE PUMP General Hospital and Personal Use Devices MEDTRONIC OF CANADA LTD. Canada HC
SYNCHROMED II - PROGRAMMABLE PUMP General Hospital and Personal Use Devices MEDTRONIC OF CANADA LTD. Canada HC
SYNCHROMED EL General Hospital and Personal Use Devices MEDTRONIC OF CANADA LTD. Canada HC
SynchroMed® II and SynchroMed EL Implantable Drug Pumps General Hospital and Personal Use Devices Medtronic Limited Ireland HPRA
SynchroMed® II Programmable Pump General Hospital and Personal Use Devices Medtronic Ireland HPRA
SynchroMed® II Implantable Drug Infusion Pump General Hospital and Personal Use Devices Medtronic Ireland HPRA
SynchroMed® II Implantable Drug Pumps General Hospital and Personal Use Devices Medtronic Ireland Limited Ireland HPRA
SynchroMed Implantable Infusion Pump General Hospital and Personal Use Devices Medtronic Inc. Denmark DMA
SynchroMed II Programmable Pump General Hospital and Personal Use Devices Medtronic Inc. Denmark DMA
SynchroMed II General Hospital and Personal Use Devices Medtronic Belgium AFMPS
Synchromed General Hospital and Personal Use Devices Medtronic Belgium AFMPS
SynchroMed II and SynchroMed EL Implanted Infusion Pump General Hospital and Personal Use Devices Medtronic Australasia Pty Ltd Australia DHTGA
SynchroMed II and SynchroMed EL Implanted Infusion Pump General Hospital and Personal Use Devices Medtronic Australasia Pty Ltd Australia DHTGA
SynchroMed II Implantable Infusion Pump General Hospital and Personal Use Devices Medtronic Australasia Pty Ltd Australia DHTGA
SynchroMed II Model 8637 Implantable Drug Infusion Pump General Hospital and Personal Use Devices Medtronic Australasia Pty Ltd Australia DHTGA