10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANTI-ENDOMYSIAL ANTIBODY TEST
FDA 510(k)
FDA Class 2
·Immunology
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668110898·TIP GUARDS VENTED YELLOW PACK OF 100
S4 SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·January 13, 2013
UPHOLD VAGINAL SUPPORT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·December 2, 2010
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code DTB·July 3, 2014
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·June 4, 2019
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·March 13, 2025
OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. 70859, 708023, 708024, 708025
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·July 4, 2018