20 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION
FDA 510(k)
FDA Class 2
·Cardiovascular
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
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
DERMATEC+PLUS(TM)& AMBIDERM(TM) LATEX EXAM GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
HSV-CHECK(TM) TEST KIT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
REALSEAL SE
FDA Adverse Event
Injury
·SYBRONENDO·Product code KIF·June 26, 2014
CXD II
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - LARGO·Product code KDJ·November 11, 2010
HERMETIC PLUS EVD SYSTEM W/O REFLUX VALVE
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES PR·Product code JXG·December 28, 2012
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024