7 results
·
22ms
·
Sources: EU EUDAMED, US FDA
KODAK M35A-M X-OMAT PROCESSOR
FDA 510(k)
FDA Class 2
·Radiology
LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA
FDA 510(k)
FDA Class 2
·Ophthalmic
POWDER-FREE VINYL EXAM GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·June 30, 2014
5.0MM TI PANGEA(TM) POLYAXIAL SCR DUAL CORE/40MM THRD LENGTH
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code NKB·January 8, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 17, 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