63 results · 26ms · Sources: EU EUDAMED, US FDA

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Applied BioPhotonics Phototherapy System ABPT1003

FDA 510(k)
FDA Class 2 ·Physical Medicine

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526550155·GENUMEDI PT KNEE SUP SILVER L EW VI

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814237·GENUMEDI PT SILVER L VI

Vilex Power Accessory

FDA UDI
VILEX IN TENNESSEE, INC.·00841731122247·KWire .054x9" (1.4x225mm)

GE LOGIQ I/E & VIVID E COMPACT DIAGNOSTIC ULTRASOUND

FDA 510(k)
FDA Class 2 ·Radiology

IR HEAT LAMP SYSTEMS: ICL 15 HFPL SYSTEM, ICL 60 PLUS HFPL SYSTEM (MODELS 40, 100 AND 250), ICL 100 ACTIVO SCANNER SYSTE

FDA 510(k)
FDA Class 2 ·Physical Medicine

DIREXION? HI-FLO?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·August 11, 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

DIREXION? FATHOM?-16 SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 9, 2026