9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
SERVICE MANAGER SM40SE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MICROTEK
FDA Adverse Event
Malfunction
·MICROTEK MEDICAL, INC.·Product code KKX·October 20, 2016
EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAE
FDA 510(k)
FDA Class 2
·Cardiovascular
VIRIDIS TWIN OPHTHALMIC PHOTOCOAGULATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·April 11, 2013
NEXGEN LPS-FLEX ARTICULAR SURFACE
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code JWH·March 1, 2011
ZIMMER MIS HIP INSTRUMENTATION LATERAL ALIGNMENT FRAME
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code LXH·May 28, 2008
WARMER DRAPE
FDA Adverse Event
Malfunction
·MICROTEK DOMINICANA, S.A.·Product code LHC·May 4, 2016
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