8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ARGILITE 4 GOLD ALLOY FOR PORCELAIN
FDA 510(k)
FDA Class 1
·Dental
STAR 50 N
FDA 510(k)
FDA Class 2
·Cardiovascular
HARDYDISK TICARCILLIN/CLAVULANIC ACID, 85MCG
FDA 510(k)
FDA Class 2
·Microbiology
UNIFY ASSURA DR CRT-D
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·June 30, 2014
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·January 4, 2013
FOLFUSOR SV 2ML/H
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·November 20, 2010
SMR SHOULDER SYSTEM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code PHX·August 22, 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