20 results · 25ms · Sources: EU EUDAMED, US FDA

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MODEL T11 FLUIDOTHERAPY UNIT

FDA 510(k)
FDA Class 2 ·Physical Medicine

DeRoyal

FDA UDI
DEROYAL INDUSTRIES, INC.·00749756730938·N/S CVR PREP PACK

PATIENT EXAM GLOVES (MFG. TERANG NUSA)

FDA 510(k)
FDA Class 1 ·General Hospital

OMNI-TRAK (PATIENT MONITOR)

FDA 510(k)
FDA Class 2 ·Anesthesiology

TRUWAVE, VAMP PLUS

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·April 21, 2026

TRUWAVE VAMP PLUS

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES·Product code DXO·April 23, 2025

TRUWAVE VAMP PLUS

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES·Product code DXO·April 23, 2025

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·June 26, 2014

ECHELON*FLEX45

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·November 11, 2010

ASR ACETABULAR IMPLANT 54

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·January 4, 2013

TRUWAVE, VAMP PLUS

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·May 2, 2025

TRUWAVE

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES·Product code DXO·August 8, 2024

TRUWAVE, VAMP PLUS

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES DR·Product code DXO·March 27, 2025

TRUWAVE, VAMP

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·March 20, 2025

TRUWAVE, VAMP

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code KRA·April 18, 2025

TRUWAVE, VAMP PLUS

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·July 26, 2024

TRUWAVE, VAMP PLUS

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code KRA·November 11, 2025

TRUWAVE, VAMP PLUS

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·July 23, 2025

TRUWAVE, VAMP

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·March 20, 2025

TRUWAVE, VAMP PLUS

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·November 26, 2025