87 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LED Curing Light
FDA 510(k)
FDA Class 2
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699571·GENUMEDI PSS BLUE, SIZE V
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
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690199564·Modular Knee Straight Reamer - 20mm
BENEPHIT BIFURCATED INFUSION CATHETER AND 5FR. INTRODUCER SHEATH
FDA 510(k)
FDA Class 2
·Cardiovascular
FRONTIER DEVICES NEURO SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
ADVANTAGE FIT BLUE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·March 24, 2025
SOLYX BLUE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code PAH·March 6, 2025
SOLYX BLUE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code PAH·January 13, 2026
SOLYX BLUE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code PAH·January 7, 2026
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026
ADVANTAGE FIT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·December 11, 2024
SOLYX BLUE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code PAH·November 14, 2025
BIB INTRAGASTRIC BALLOON SYSTEM
FDA Adverse Event
Malfunction
·APOLLO ENDOSURGERY·Product code LTI·June 27, 2024
OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM
FDA Adverse Event
Malfunction
·APOLLO ENDOSURGERY·Product code OCW·August 28, 2025
LYNX ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·September 4, 2025
AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code PCU·April 23, 2024
PERCUFLEX URINARY DIVERSION STENT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code LJE·May 15, 2025
OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OCW·March 20, 2026