30 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask
FDA 510(k)
FDA Class 2
·Anesthesiology
BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
XTRAC XL, MODEL AL8000
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BARD COMPOSIX KUGEL MESH PATCH
FDA Adverse Event
Injury
·DAVOL, INC. SUB. C.R. BARD, INC.·Product code FTL·November 17, 2008
ENDOTAK RELIANCE
FDA Adverse Event
Death
·CPI - DEL CARIBE·Product code NVY·September 9, 2011
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·July 22, 2013
PERITX DRAINAGE BAG
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·April 3, 2026
PERITX PERITONEAL CATHETER & STARTER KIT
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·October 6, 2025
PERITX PERITONEAL CATHETER & STARTER KIT
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·October 6, 2025
PERITX PERITONEAL CATHETER & STARTER KIT
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·October 6, 2025
PERITX PERITONEAL CATHETER & STARTER KIT
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·October 6, 2025
PERITX PERITONEAL CATHETER & STARTER KIT
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·April 2, 2026
PLEURX DRAINAGE KIT 1000ML
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·January 20, 2026
Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients.
FDA Enforcement
Class II
·Terminated·Synthes USA HQ, Inc.·December 4, 2013
PERITX PERITONEAL CATHETER & STARTER KIT
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·October 6, 2025
PERITX PERITONEAL CATHETER & STARTER KIT
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·October 6, 2025
PLEURX DRAINAGE KIT 1000ML
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·October 15, 2025
PERITX
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·November 26, 2025
VALVE CAP
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·November 5, 2025
PERITX PERITONEAL CATHETER & STARTER KIT
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·October 6, 2025