45 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PRIMUS STEAM STERILIZER, MODELS PSS5-G-1 AND PSS5-M
FDA 510(k)
FDA Class 2
·General Hospital
HELICAL COMPRESSION ANCHOR SYSTEM, NON-CANNULATED
FDA 510(k)
FDA Class 2
·Orthopedic
SYNETEC
FDA 510(k)
FDA Class 2
·Cardiovascular
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 2, 2021
CUSTOM TUBING - SET INC. OXYGENATOR
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DWE·April 24, 2015
QUADROX COMPLETE PACK
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·November 24, 2014
HLM TUBING SET W/SOFTLINE COATING
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DWF·July 13, 2015
QUADROX-I HMO 70000+VHK70000
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·July 7, 2015
HMO 71000-J#QUADROX-1 ADULT + FILTER
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·March 3, 2015
HLM TUBING SET W/SOFTLINE COATING
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DWF·July 16, 2015
HQC 16602-3#HL-SET, OFFENES SYSTEM
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·December 19, 2014
DESCRIPTION FROM THE CUSTOMER REPORT:
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·August 19, 2016
QUADROX-I ADULT WITH INTEGRATED FILTER
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·August 17, 2016
CUSTOM TUBING - SET INCL. HMO 71000
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DWE·April 14, 2015
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·April 29, 2013
INTERSTIM II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·May 3, 2011
BLANKETROL II
FDA Adverse Event
Malfunction
·CINCINNATI SUB-ZERO PRODUCTS, INC.·Product code DWJ·July 17, 2008
HLM TUBING SET W/SOFTLINE COATING
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·December 22, 2015
HLM TUBING SET W/SOFTLINE COATING
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·July 1, 2015
HLM TUBING SET
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTZ·June 27, 2016