7 results
·
34ms
·
Sources: EU EUDAMED, US FDA
NONABSORBABLE DACRON SURGICAL SUTURE*
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SHEA LOCKING BAIL PROSTHESIS
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
REVERSE SHOULDER PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 30, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 9, 2013
AQUILION-32
FDA Adverse Event
Malfunction
·TOSHIBA AMERICA MEDICAL SYSTEMS, INC.·Product code JAK·September 30, 2010
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