67 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GammaBeam 100
FDA 510(k)
FDA Class 2
·Radiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550131·GENUMEDI PT KNEE SUP SILVER L EW IV
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550148·GENUMEDI PT KNEE SUP SILVER L EW V
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550124·GENUMEDI PT KNEE SUP SILVER L EW III
TAPAS CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SOCORRO SMI TUNNEL RELEASE DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DIREXION? HI-FLO?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·August 11, 2025
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523136667·Ti-6Al-4V ALIF Implant 42 X 32, 19mm Height 17°...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523163670·PEEK ALIF Implant 42 X 32, 19mm Height, 17° Lor...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523157426·Tesera-k ALIF, 42W X 32D, 19mm, 12° Broach
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523152247·Tesera-k SA, 42mm X 32mm X 19mm, 12° Lordosis, T3
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523156672·Tesera-k ALIF, 42W X 32D, 19mm, 12° Trial
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523137770·Trial, 42 X 32, 19mm Height 17° Hyperlordotic
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138678·Broach, 42 X 32, 19mm Height 17° Hyperlordotic
DIREXION?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·August 19, 2025
DIREXION? TRANSEND?-14 SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·January 26, 2026
DIREXION?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·May 2, 2025
DIREXION?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·December 16, 2025
DIREXION?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·April 21, 2025
DIREXION? HI-FLO?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 24, 2026