10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
TSO3 OZONE STERILIZER, MODEL 125L
FDA 510(k)
FDA Class 2
·General Hospital
LEONE SPA
FDA UDI
LEONE SPA·08033707000013·SYMMETRIC FAN-TYPE SCREWS S/STEEL 15mm
GYRUS ENT NERVE STIMULATOR
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
U & I AMERICA SPINAL HOOK SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·April 10, 2013
UNIFY CRT-D, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·September 2, 2014
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 12, 2011
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·December 10, 2010
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·January 10, 2019
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