PFO

Product Code: PFO


Products Classified as PFO

1637Active Implantable Bone Conduction Hearing System

Total Product Life Cycle (TPLC) Devices

1637Active Implantable Bone Conduction Hearing System

Pre-market Notifications for PFO

K220922Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI KitCochlear Americas
K201983BCI 602 Lifts (1 Mm), BCI Lifts (1 Mm), BCI Lifts (2 Mm & 3 Mm), BCI Lifts (4 Mm)Med-El Elektromedizinische Geraete GmbH
K200504BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 RemoteMED-EL Elektromedizinische Geraete GmbH
K191921Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical InstrumentsCochlear Americas
K191457BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)MED-EL Elektromedizinische Geraete GmbH
K190589Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical InstrumentsCochlear Americas
K183373BonebridgeMED-EL Elektromedizinische Geraete GmbH

Global Unique Device Identification Database

09008738521805Active Implantable Bone Conduction Hearing System
09008737524852Active Implantable Bone Conduction Hearing System
09008737524845Active Implantable Bone Conduction Hearing System
09008737524838Active Implantable Bone Conduction Hearing System
09008737522605Active Implantable Bone Conduction Hearing System
09321502046626Active implantable bone conduction hearing system
09321502046619Active implantable bone conduction hearing system
09321502046602Active implantable bone conduction hearing system
09321502046596Active implantable bone conduction hearing system
09321502046589Active implantable bone conduction hearing system
09321502045148Active implantable bone conduction hearing system
09321502045131Active implantable bone conduction hearing system
09321502045124Active implantable bone conduction hearing system
09321502044967Active implantable bone conduction hearing system
09008737531065Active Implantable Bone Conduction Hearing System

Maude Adverse Events

COCHLEAR OSIA OSI200 IMPLANTCOCHLEAR LTD2020-03-26
COCHLEAR OSIA OSI200 IMPLANTCOCHLEAR LTD2020-03-26
COCHLEAR OSIA OSI100 IMPLANTCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-11
COCHLEAR OSIA OSI100 IMPLANTCOCHLEAR BONE ANCHORED SOLUTIONS AB2020-03-11
COCHLEAR OSIA OSI200 IMPLANTCOCHLEAR LTD2020-02-10
COCHLEAR OSIA OSI200 IMPLANTCOCHLEAR LTD2020-02-09
BONEBRIDGEMED-EL ELEKTROMEDIZINISCHE GERAETE GMBH2020-02-06
COCHLEAR OSIA OS2100 IMPLANTCOCHLEAR LTD2020-02-04
COCHLEAR OSIA OS2100 IMPLANTCOCHLEAR LTD2020-02-04
BONEBRIDGEMED-EL ELEKTROMEDIZINISCHE GERAETE GMBH2020-02-03
BONEBRIDGEMED-EL ELEKTROMEDIZINISCHE GERAETE GMBH2020-01-16
COCHLEAR OSIA OSI100 IMPLANTCOCHLEAR BONE ANCHORED SOLUTIONS AB2019-11-14
OSI 100 IMPLANTCOCHLEAR LTD2019-10-21
BONEBRIDGEMED-EL ELEKTROMEDIZINISCHE GERAETE GMBH2019-09-04
OSI100 IMPLANTCOCHLEAR LTD2019-08-20
BONEBRIDGEMED-EL ELEKTROMEDIZINISCHE GERAETE GMBH2019-08-19
BONEBRIDGEMED-EL ELEKTROMEDIZINISCHE GERAETE GMBH2019-08-13
BONEBRIDGEMED-EL ELEKTROMEDIZINISCHE GERAETE GMBH2019-08-06
BONEBRIDGEMED-EL ELEKTROMEDIZINISCHE GERAETE GMBH2019-07-24
BONEBRIDGEMED-EL ELEKTROMEDIZINISCHE GERAETE GMBH2019-07-17
BONEBRIDGEMED-EL ELEKTROMEDIZINISCHE GERAETE GMBH2019-07-05
BONEBRIDGEMED-EL ELEKTROMEDIZINISCHE GERAETE GMBH2019-05-21
BONEBRIDGEMED-EL ELEKTROMEDIZINISCHE GERAETE GMBH2019-04-29
BONEBRIDGEMED-EL ELEKTROMEDIZINISCHE GERAETE GMBH2019-03-01
BONEBRIDGEMED-EL ELEKTROMEDIZINISCHE GERAETE GMBH2019-02-22
BONEBRIDGEMED-EL ELEKTROMEDIZINISCHE GERAETE GMBH2019-02-20
BONEBRIDGEMED-EL ELEKTROMEDIZINISCHE GERAETE GMBH2019-02-18
BONEBRIDGEMED-EL ELEKTROMEDIZINISCHE GERAETE GMBH2019-02-18
BONEBRIDGEMED-EL ELEKTROMEDIZINISCHE GERAETE GMBH2019-02-05
BONEBRIDGEMED-EL ELEKTROMEDIZINISCHE GERAETE GMBH2019-01-31
BONEBRIDGEMED-EL ELEKTROMEDIZINISCHE GERAETE GMBH2019-01-31
BONEBRIDGEMED-EL ELEKTROMEDIZINISCHE GERAETE GMBH2018-12-05
BONEBRIDGEMED-EL ELEKTROMEDIZINISCHE GERAETE GMBH2018-10-29
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