49 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EzRay Air W
FDA 510(k)
FDA Class 2
·Dental
Biomet® Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868310836·
BIOMET HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304256835·
Sklar
FDA UDI
SKLAR CORPORATION·10649111402173·SIMS TC UTER SCISS 9 INCHES CV SH/SH
LOW PROFILE SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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
DIREXION? FATHOM?-16 SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·July 8, 2025
DIREXION? HI-FLO? TRANSEND?-18 SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·May 14, 2026
DIREXION? TRANSEND?-14 SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·March 4, 2026