21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNERMED MAGNESIUM REAGENT KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE
FDA 510(k)
FDA Class 2
·Cardiovascular
MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025
FDA 510(k)
FDA Class 2
·Microbiology
HLM TUBING SET
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·April 1, 2015
VKMO 70000 #QUADROX-I HMO 70000+VHK71
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTN·February 23, 2015
BO-HQV 70600#ADULT PACK
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTN·February 19, 2015
BO-HQV #70600ADULT PACK
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTN·March 4, 2015
BO-HQV 70600#ADULT PACK
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DWE·March 27, 2015
BO-HQV 70600#ADULT PACK
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DWE·April 9, 2015
VKMO 11000
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·February 24, 2015
BO-HQV 70600 ADULT PACK
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTN·July 15, 2015
RESERVOIR VHK
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTN·July 28, 2015
VENOUS HARDSHELL CARDIOTOMY RESERVOIR
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTM·September 13, 2016
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·June 30, 2014
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·October 26, 2007
ITOTAL G2
FDA Adverse Event
Malfunction
·CONFORMIS·Product code JWH·November 29, 2012
VENOUS HARDSHELL CARDIOTOMY RESERVOIR
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTM·September 13, 2016
VKMO 78000
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTM·May 6, 2016
VKMO 30000 # QUADROX - I PAD. MIT RESERVOIR
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTM·July 17, 2015
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024