10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Dental Lithium Disilicate Glass-Ceramic
FDA 510(k)
FDA Class 2
·Dental
Bernafon
FDA UDI
Sbo Hearing A/S·05714464028887·AO9 MNR T SABE/MAC ALIGO 9 DEMO
PERKINS RETRACTOR
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896026711·PERKINS RETRACTOR RIGHT BLADE
FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
R 72
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 20, 2025
PULSE GEN MODEL UNK
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·August 12, 2011
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 16, 2013
LCS TEX ROT PLAT TIB PLAT STD+
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code NJL·January 17, 2008
CODMAN Disposable Perforator, 14mm. Cranial perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025