14 results
·
36ms
·
Sources: EU EUDAMED, US FDA
DANNINGER TRIMCHECK(TM) PORTABLE & DESK TOP MODELS
FDA 510(k)
FDA Class 2
·Cardiovascular
CARDIOHELP
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code DTQ·April 8, 2024
CARDIOHELP
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code DTQ·April 4, 2024
AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
BAR, DISTRACTION
FDA 510(k)
FDA Class 2
·Orthopedic
CARDIOHELP
FDA Adverse Event
Malfunction
·JULIA KAPFENBERGER·Product code DTQ·May 15, 2024
THREADED INSERTER
FDA Adverse Event
Malfunction
·MSD BARTLETT MFG·Product code MAX·June 18, 2014
POLYURETHANE CONTRAST INJECTION LINE
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DXJ·October 8, 2010
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON INC·Product code OTN·December 20, 2012
CARDIOHELP
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code DTQ·March 5, 2024
THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·July 31, 2017
CARDIOHELP
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code DTQ·February 26, 2024
CARDIOHELP
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code DTQ·November 13, 2023
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024