20 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Pinnacle Duofix HA Acetabular Cup Prosthesis
FDA 510(k)
FDA Class 2
·Orthopedic
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
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 2014
CAPIO SUTURE BON GN BR TC-43 2N 48"
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code GCJ·July 22, 2011
CERVIOS WEDGE-SHAPED SIZ 7 PEEK
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code JDQ·June 27, 2013
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
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·April 27, 2016