417 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
SPECTRANETICS QUICK-CROSS SUPPORT CATHETER
FDA Adverse Event
Injury
·THE SPECTRANETICS CORPORATION·Product code DQY·March 6, 2019
Accent Buccal Tube
FDA UDI
ORMCO CORPORATION·00889989053999·ACCENT B/T 5SGL F/S WDX 0TX22 UL/LR
Misc
FDA UDI
ORMCO CORPORATION·00889989054996·LINGUAL CUSP BICUSP SEAT LUG EACH
Kirwan
FDA UDI
KIRWAN SURGICAL PRODUCTS LLC·00841019112113·Reusable Bipolar Forceps 10" (25.4cm) Hardy Bay...
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120571·Guidewire 2.0x150mm Sgl Trocar
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120564·Guidewire 2.0x150mm Dbl Trocar
Prelude®
FDA UDI
Merit Medical Systems, Inc.·10884450199333·
AEU-14CF EXPENDITION
FDA 510(k)
FDA Class 1
·Dental
EXPLOR RADIAL HEAD PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code PCU·July 2, 2025
AXIOS?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·August 14, 2025
TECNIS CL
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQL·July 6, 2011
PAINSMART IOD
FDA Adverse Event
Malfunction
·MOOG DRIVE GROUP·Product code FRN·May 28, 2013
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·Product code OZO·October 7, 2014
SOLYX SIS SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code PAH·September 10, 2024
SOLYX SIS SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code PAH·July 1, 2024
AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code PCU·January 6, 2026
AXIOS?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025
AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code QXH·January 5, 2026