5 results
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36ms
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Sources: EU EUDAMED, US FDA
PERCDLE DEVICE CONVENIENCE PACK
FDA Adverse Event
Other
·ARTHROCARE CORP.·Product code GEI·June 17, 2011
BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: BrightMatter Guide can navigate a third-party port (NICO BrainPath device) by attaching Synaptive s custom Tracking Array to the port directly. As the BrainPath is navigable in two configurations (sheath only / sheath and obturator), the tip of the obturator is represented in the software with a tip extension beyond the bottom of the sheath. Note sheath and cannula are used interchangeably in this document.
FDA Recall
Terminated
·Synaptive Medical Inc·Product code HAW·October 9, 2018
BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: BrightMatter Guide can navigate a third-party port (NICO BrainPath device) by attaching Synaptive s custom Tracking Array to the port directly. As the BrainPath is navigable in two configurations (sheath only / sheath and obturator), the tip of the obturator is represented in the software with a tip extension beyond the bottom of the sheath. Note sheath and cannula are used interchangeably in this document.
FDA Enforcement
Class I
·Terminated·Synaptive Medical Inc·December 5, 2018
Beryl Med Poland Spółka z ograniczoną odpowiedzialnością
Importer
🇵🇱 Poland·12 Manufacturers
MDSS GmbH
Authorized representative
🇩🇪 Germany·388 Manufacturers·16562 Devices