8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ESPI TISSUE GRASPER/NEEDLE HOLDER, #8201
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Brigade
FDA UDI
Nuvasive, Inc.·00887517964052·Brigade Lateral Trial, 11x38x32mm 20°
MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CARRIAZO BARRAQUER SINGLE USE MICROKERATOME
FDA 510(k)
FDA Class 1
·Ophthalmic
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 30, 2014
PROMUS ELEMENT¿ PLUS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·January 9, 2013
ADVIA CENTAUR
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJE·November 16, 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