19 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EIGR SURGICAL ILLUMINATION SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TORQTECH
FDA 510(k)
FDA Class 1
·Dental
TIGER SYRINGES AND NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
CHARGER?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·November 17, 2025
CHARGER?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·November 21, 2025
CHARGER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·June 2, 2025
CHARGER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·March 27, 2025
CHARGER?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 10, 2025
CHARGER?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·November 17, 2025
CHARGER?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·August 6, 2025
CHARGER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·March 25, 2025
FOUNDATION HIP
FDA Adverse Event
ENCORE MEDICAL, L.P.·Product code KWA·May 15, 2013
MAQUET HCU30 DEVICE
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DWC·September 17, 2014
EON C 16-CHANNEL IPG
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 2, 2011
CHARGER?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·August 28, 2025
CHARGER?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·February 2, 2026
CHARGER?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·September 26, 2025
Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;
FDA Enforcement
Class II
·Ongoing·Ventec Life Systems, Inc.·June 30, 2021
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021