8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
ORAL-CATH SUCTION CATHETER
FDA 510(k)
FDA Class 1
·Anesthesiology
Brigade
FDA UDI
Nuvasive, Inc.·00887517963635·Brigade Lateral Trial, 14x38x28mm 30°
ITI DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
EVOLUTION MP TOTAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
530G INSULIN PUMP
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 30, 2014
UNIDENTIFIED HIP IMPLANT OR INSTRUMENT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWY·January 9, 2013
DISCOVERY CT750 HD
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS, LLC·Product code JAK·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