152 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Conformis BeneFIT Hip System
FDA 510(k)
FDA Class 2
·Orthopedic
2008® Series Hemodialysis Machines
FDA UDI
Fresenius Usa, Inc.·00840861100965·2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG
LEONE SPA
FDA UDI
LEONE SPA·08033707065715·INTRAORAL ELASTICS 4,5 oz 5/16" blue
UniTip Catheter
FDA UDI
Unisensor AG·07640172972380·
POLARIS DIAL-A-DATE CONTACT LENS CASE
FDA 510(k)
FDA Class 2
·Ophthalmic
RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code FZP·October 9, 2008
UNKNOWN DEPUY TIBIAL TRAY
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·July 27, 2011
EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·June 26, 2013
190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KDI·June 3, 2024
190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·July 17, 2024
2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System - 1st Gen. -¿ Canada; 190828 2008K at Home System - 2nd Gen - U.S.; 190904 2008K at Home System w/ Bibag; 190828 2008KatHOME HEMODIALYSIS SYSTEM; 190395 2008KatHOME MACHINE, SHORT CAB, OLC/DP, HP The Fresenius 2008K is indicated for acute and chronic dialysis therapy.
FDA Enforcement
Class II
·Terminated·Fresenius Medical Care Holdings, Inc.·May 6, 2015
BD PANEL PHOENIX NMIC-311
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·August 18, 2024
BD PANEL PHOENIX NMIC-311
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 2, 2024
BD PHOENIX PANEL NMIC-306
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·September 2, 2025
BD PHOENIX PANEL NMIC-306
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·September 2, 2025
BD PHOENIX PANEL NMIC-306
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·October 24, 2024
BD PHOENIX¿ NMIC-306
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·December 17, 2024
BD PHOENIX¿ NMIC-306
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·June 12, 2025
BD PHOENIX¿ NMIC-306
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·June 12, 2025