50 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Bodycad Unicompartmental Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
Mouthpiece, Disposable, 1.045" O.D., 2.625" L
FDA UDI
A-M SYSTEMS, LLC·00817081024111·Mouthpiece, Disposable, 1.045" O.D., 2.625" L
Biomet® Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868310782·
BIOMET HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304256767·
Sklar
FDA UDI
SKLAR CORPORATION·10649111402128·SIMS TC UTER SCISS 9 INCHESSTR SH/BL
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04059993056439·ELVAREX FORTE 3/KNEE HIGH/PROFILE-CLOSED TOE-EL...
SPYGLASS IRRIGATION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ESSENTIAL MRI PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
II Ring Retractor
FDA UDI
Automated Medical Products Corp.·00810118342691·Segmented Oval Ring Medium 10.5" x 19"
DIREXION? HI-FLO?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·August 11, 2025
DIREXION HI-FLO FATHOM-16 SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 13, 2025
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
DIREXION? TRANSEND?-14 SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·December 10, 2025
DIREXION? HI-FLO? FATHOM?-16 SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·April 23, 2025
DIREXION TRANSEND-14 SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·March 31, 2025