7 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B
FDA 510(k)
FDA Class 2
·Cardiovascular
AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE, MODEL M1175A/76A/77A,REV.L,M1205A,REV.L,M1034A
FDA 510(k)
FDA Class 2
·Neurology
SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010
FDA 510(k)
FDA Class 2
·Cardiovascular
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·April 8, 2013
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008
SM104 M-SERIES W/5TH WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·April 21, 2011
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