10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Cardiovascular
GC Initial™
FDA UDI
Gc America Inc.·D0470128371·GC Initial™ LiSi Press Ingot LT-B0 (3gx5)
GC Initial™
FDA UDI
Gc America Inc.·14548161315562·GC Initial™ LiSi Press Ingot LT-B0 (3gx5)
EYE SENTIAL
FDA UDI
FGX INTERNATIONAL INC.·00193033444887·
BIS ENGINE
FDA 510(k)
FDA Class 2
·Neurology
HANDMASTER
FDA 510(k)
FDA Class 2
·Neurology
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·March 1, 2013
GYNNIE OB-GYN STRETCHER
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·March 3, 2011
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE SJ·Product code JPA·March 11, 2008
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