8 results
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34ms
·
Sources: EU EUDAMED, US FDA
ACU007S
FDA 510(k)
FDA Class 2
·Radiology
OPART, MODEL MRT-600
FDA 510(k)
FDA Class 2
·Radiology
WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL
FDA 510(k)
FDA Class 2
·Radiology
COCR FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·October 31, 2025
ANKLE ARTHRODESIS NAIL, LEFT T2 ANKLE Ø11X150MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS-KIEL·Product code HSB·May 3, 2013
ACCU-CHEK ® INFORM II TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 16, 2014
TERUMO CDI 540 CALIBRATOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DRY·May 2, 2011
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