8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
FIBER OPTIC LIGHT SOURCE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
ALOKA UST-5280-5
FDA 510(k)
FDA Class 2
·Radiology
C. ALBICANS/C. GLABRATA PNA FISH
FDA 510(k)
FDA Class 1
·Microbiology
SMR HUMERAL HEAD Ø42 MM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWT·August 28, 2020
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 9, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·November 18, 2010
CUSTOM PAK
FDA Adverse Event
Malfunction
·ALCON - HOUSTON·Product code KYG·February 14, 2014
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