6 results
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43ms
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Sources: EU EUDAMED, US FDA
THEMA USA LLC
FDA registration
THEMA USA LLC·2 products·🇺🇸 United States
VOLISTA 600 SF
FDA Adverse Event
Malfunction
·MAQUET SAS·Product code FSY·March 13, 2019
S-Series Long Range Headpiece Model Number AB-5301-00 (beige) and AB-5301-10 (brown) ADVANCED BIONICS LLC 12740 San Fernando Rd. Sylmar, CA 91342 USA. The headpiece is used in conjunction with speech processors manufactured by Advanced Bionics.
FDA Recall
Terminated
·Advanced Bionics LLC·Product code MCM·July 24, 2008
S-Series Short Range Headpiece Model Number MMT-5300-00 (beige) and MMT-5300-10 (brown) ADVANCED BIONICS LLC 12740 San Fernando Rd. Sylmar, CA 91342 USA. The headpiece is used in conjunction with speech processors manufactured by Advanced Bionics.
FDA Recall
Terminated
·Advanced Bionics LLC·Product code MCM·July 24, 2008
HR90K Platinum Series Headpiece Model Number AB-7300-001 ADVANCED BIONICS LLC 12740 San Fernando Rd. Sylmar, CA 91342 USA. The HiRes90K headpiece is used in conjunction with speech processors manufactured by Advanced Bionics. The Harmony HiResolution Bionic Ear System and Clarion Multi-Strategy Cochlear Implant are cochlear implant systems designed to provide useful hearing to individuals with severe-to-profound sensorineural hearing loss.
FDA Recall
Terminated
·Advanced Bionics LLC·Product code MCM·July 24, 2008
CMC Medical Devices & Drugs SL
Authorized representative
🇪🇸 Spain·698 Manufacturers·11260 Devices