36 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TriMed Bridge Plates
FDA 510(k)
FDA Class 2
·Orthopedic
MIDLINE II TI
FDA 510(k)
FDA Class 2
·Orthopedic
M2376A DEVICELINK SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
TENSIONER
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code LXH·November 20, 2014
BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·August 27, 2018
TENSIONER
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code LXH·November 20, 2014
BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·March 29, 2019
BD ULTRA-FINE¿ INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·June 21, 2018
PUNCTUA
FDA Adverse Event
Death
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·September 9, 2011
ADAPTER SLEEVES 12/14 +2
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·November 10, 2014
DEPUY ASR XL FEM IMP SIZE 51
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KXA·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
TENSIONER
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code LXH·November 20, 2014