8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ADD MIX ALLERGEN PANEL MOD ALASTAT(R) ALLERGEN IGE
FDA 510(k)
FDA Class 2
·Immunology
IdentiTi ALIF Standalone Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
ACCELL EVO3 (FORMERLY ACCELL A2I)
FDA 510(k)
FDA Class 2
·Orthopedic
UNIFY ASSURA DR CRT-D, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·June 30, 2014
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTP·January 9, 2013
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·November 20, 2010
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·October 23, 2025
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