67 results · 25ms · Sources: EU EUDAMED, 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