10 results
·
26ms
·
Sources: EU EUDAMED, US FDA
MONITRODE
FDA 510(k)
FDA Class 2
·Cardiovascular
Brigade
FDA UDI
Nuvasive, Inc.·00887517963024·Brigade Lateral Trial, 7x38x28mm 8°
STEM: SMS SOLID STEM LAT SIZE 7
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·January 26, 2021
SKYLINE ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HIP SEXTANT INSTRUMENT SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
SET SCREW, TI GAMMA3® Ø8X17.5MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code HSB·July 22, 2014
DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM DEXCOM SHARE SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 9, 2015
JAMSHIDI
FDA Adverse Event
Malfunction
·CAREFUSION·Product code KNW·January 4, 2013
MINIARC SLING SYSTEMS
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·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