26 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·November 7, 2025
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·May 23, 2025
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·March 25, 2026
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·October 28, 2025
LYNX ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·December 12, 2025
LYNX ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·September 4, 2025
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·April 15, 2026
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526780750·LEVAMED ACTIVE ANKLE SUP SLVR L III
Comprehensive® SRS
FDA UDI
Biomet Orthopedics, LLC·00880304540828·
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551112341·HALO, 1203-5 VEST MEDIUM, LAMBSWOOL LINER, 1211...
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0112230·Tap, 5.50mm, Cannulated, Fixed Sleeve
QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
AMSCO CHIMERON SMALL STEAM STERILIZER
FDA 510(k)
FDA Class 2
·General Hospital
GORE TAG THORACIC ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·August 3, 2011
2250051-2008-00345
FDA Adverse Event
Malfunction
·Product code JTC·July 30, 2008
EDWARDS ASCENDRA INTRODUCER SHEAT SET
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code NPT·July 8, 2013
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·May 15, 2023