51 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01
FDA 510(k)
FDA Class 2
·Immunology
Waterpik Densco Condensaire Amalgam Condenser
FDA UDI
WATER PIK, INC.·D6860831170005·Complete kit - includes instrument, tips, and t...
PRIMAGARD SURGICAL GOWNS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RESECTION ABLATOR
FDA 510(k)
FDA Class 2
·Orthopedic
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
LUMAX 540 HF-T
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NIK·April 29, 2013
DEXTRUS 4136
FDA Adverse Event
Other
·BIOTRONIK SE & CO. KG·Product code NVZ·April 29, 2011
HIRES 90K
FDA Adverse Event
Malfunction
·ADVANCED BIONICS LLC·Product code MCM·July 24, 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
BD¿ 5ML SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·November 15, 2017