136 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AcuityUDR
FDA 510(k)
FDA Class 2
·Radiology
COMPREHENSIVE NEUROMUSCULAR PROFILER
FDA 510(k)
FDA Class 2
·Physical Medicine
CUBEScan BioCon-1100
FDA 510(k)
FDA Class 2
·Radiology
HILL-ROM
FDA Adverse Event
Other
·HILL-ROM·Product code FNL·February 2, 1998
REFLEX
FDA Adverse Event
Death
·TELECTRONICS PACING SYSTEMS INC·Product code DXY·February 6, 1998
INNER SHEATH, FOR 26 FR. OUTER SHEATH
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·August 6, 2024
ARROW INTERVENTIONAL PSI SET
FDA Adverse Event
Injury
·ARROW INTL., INC.·Product code DYB·May 12, 1998
UNK
FDA Adverse Event
Injury
·UNK·Product code CAZ·December 19, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JQX·September 1, 2011
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 4, 2014
CONMED 5MM AUTOMATIC CLIP APPLIER
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code FZP·July 15, 2013
INNER SHEATH, FOR 26 FR. OUTER SHEATH
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·February 15, 2023
INNER SHEATH, FOR 26 FR. OUTER SHEATH
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·March 14, 2023
GEL FILLED MAMMARY IMPLANT
FDA Adverse Event
Injury
·DOW CORNING CORP·Product code FTR·October 16, 1996
PADGETT ELECTRO-DERMATOME MODEL B 110 V
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES CORPORATION·Product code GFD·January 19, 2006
INNER SHEATH, FOR 26 FR. OUTER SHEATH
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·August 18, 2025
RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·October 19, 2025
RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·October 19, 2025
RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·October 19, 2025
RESECTION SHEATH, 24 FR.
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·October 27, 2025