20 results
·
20ms
·
Sources: EU EUDAMED, US FDA
EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM
FDA 510(k)
FDA Class 1
·Microbiology
TRIMED STERILE PRODUCT
FDA 510(k)
FDA Class 2
·Orthopedic
PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
9616240-2006-00341
FDA Adverse Event
Malfunction
·Product code FII·June 14, 2006
9616240-2006-00332
FDA Adverse Event
Other
·Product code FII·June 1, 2006
PHOENIX
FDA Adverse Event
Malfunction
·GAMBRO DASCO·Product code FII·May 10, 2006
9616240-2006-00339
FDA Adverse Event
Malfunction
·Product code FII·June 9, 2006
9616240-2006-00340
FDA Adverse Event
Malfunction
·Product code FII·June 9, 2006
MENTOR SMOOTH ROUND MODERATE PLUS PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·May 7, 2020
9616240-2006-00350
FDA Adverse Event
Malfunction
·Product code FII·June 23, 2006
9616240-2006-00345
FDA Adverse Event
Malfunction
·Product code FII·June 14, 2006
PHOENIX
FDA Adverse Event
Malfunction
·GAMBRO DASCO·Product code FII·May 10, 2006
PHOENIX
FDA Adverse Event
Malfunction
·GAMBRO DASCO·Product code FII·May 10, 2006
MENTOR SMOOTH ROUND MODERATE PLUS PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·May 7, 2020
MENTOR SMOOTH ROUND MODERATE PLUS PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·May 7, 2020
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·June 30, 2014
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·November 10, 2010
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·January 8, 2013
ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma Camera Systems. Distributed by Philips Medical Systems, Cleveland, OH
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·January 29, 2014
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012