50 results
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24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ELEVATE Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
ELEVATE SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code MAX·July 8, 2020
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
FDA 510(k)
FDA Class 1
·General Hospital
GEM-TWIN TENS/ MODELS GM3XY/Z
FDA 510(k)
FDA Class 2
·Neurology
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970072·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970102·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970089·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970119·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970096·
DIREXION? HI-FLO?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·August 11, 2025
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970812·
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