35 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SmoothCool HR System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE DIGITAL IMAGING SYSTEM, NIOBE ELECTROPHYSIOLOGY MAPPING CATH
FDA 510(k)
FDA Class 2
·Cardiovascular
SAVIEW-COLORS 42 UV (HEFILCON A) ,TORIC (HEFILCON A), MULTIFOCAL (HEFILCON A)SOFT (HYDROPHILIC) CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
GLP TRACK END
FDA Adverse Event
Malfunction
·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·May 18, 2026
DEFIBRILLATOR/PACEMAKER
FDA Adverse Event
Death
·ZOLL MEDICAL CORP·Product code LDD·October 29, 2008
ULTRAFLEX¿ TRACHEOBRONCHIAL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code JCT·August 16, 2011
URETEX SUP URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTN·April 9, 2013
ENSITE CLASSIC SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code DQK·February 9, 2010
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·December 18, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·December 16, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·May 20, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·June 10, 2024
GLP CENTRIFUGE MODULE
FDA Adverse Event
Malfunction
·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·July 10, 2025
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·December 13, 2024
GLP CENTRIFUGE MODULE
FDA Adverse Event
Malfunction
·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·December 27, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·November 11, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·November 11, 2024
GLP CENTRIFUGE MODULE
FDA Adverse Event
Malfunction
·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·April 28, 2025
GLP ALIQUOT MODULE
FDA Adverse Event
Malfunction
·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·August 1, 2025
GLP TRACK END
FDA Adverse Event
Malfunction
·ABBOTT AUTOMATION SOLUTIONS GMBH·Product code JQP·April 1, 2026