155 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL 5000 SONO ULTRASOUND SYSTEM, RELIANT BTL 5000 COMBI
FDA 510(k)
FDA Class 2
·Physical Medicine
PROTEGE STENT
FDA Adverse Event
Other
·*·Product code FGE·May 5, 2006
NEOTRACT UROLIFT ATC SYSTEM
FDA Adverse Event
Malfunction
·NEOTRACT, INC.·Product code PEW·May 6, 2022
VITEK® 2 GP TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC·Product code LQL·March 29, 2017
NEOTRACT UROLIFT SYSTEM UL400
FDA Adverse Event
Injury
·NEOTRACT, INC.·Product code PEW·October 3, 2019
NEOTRACT UROLIFT SYSTEM UL400
FDA Adverse Event
Injury
·NEOTRACT, INC.·Product code PEW·August 8, 2019
NEOTRACT UROLIFT SYSTEM UL400
FDA Adverse Event
Injury
·NEOTRACT, INC.·Product code PEW·June 10, 2020
THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·June 4, 2024
COMMANDER DS WITH SAPIEN 3
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·March 30, 2021
HEART LUNG MACHINE
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code KFM·September 6, 2021
NONIN WRISTOX2 PULSE OXIMETER
FDA Adverse Event
Injury
·NONIN MEDICAL INC.·Product code DQA·November 23, 2017
IMPELLA CP
FDA Adverse Event
Injury
·ABIOMED, INC.·Product code OZD·August 6, 2024
HEARTMATE 3 LVAS IMPLANT KIT
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·April 16, 2024
ACCESS® ACCUTNI
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code MMI·July 31, 2013
WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NGV·January 5, 2018
NCP BIPOLAR LEAD
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·October 24, 2003
PRECISION SPECTRA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 1, 2024
NITI-S ESOPHAGEAL COVERED STENT
FDA Adverse Event
Injury
·TAEWOONG MEDICAL CO.,LTD.·Product code ESW·April 13, 2017
RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM
FDA Adverse Event
Injury
·BOLTON MEDICAL, INC.·Product code MIH·November 20, 2024
SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·May 31, 2017