8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
CHIROFLEX FORCEPS
FDA 510(k)
FDA Class 1
·Ophthalmic
Brigade
FDA UDI
Nuvasive, Inc.·00887517963864·Brigade Lateral Trial, 10x38x32mm 12°
MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
GLUMA DESENSITIZER POWER GEL
FDA 510(k)
FDA Class 2
·Dental
530G INSULIN PUMP
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 30, 2014
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·January 9, 2013
X7000 XENON LIGHTSOURCE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·November 15, 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