8 results
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36ms
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Sources: EU EUDAMED, US FDA
MED-LOK
FDA 510(k)
FDA Class 2
·General Hospital
BIOEMG II AND BIOJVA
FDA 510(k)
FDA Class 2
·Physical Medicine
MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE
FDA 510(k)
FDA Class 2
·Dental
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·May 4, 2013
INSTINCT ENDOSCOPIC HEMOCLIP
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code FHN·August 21, 2014
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DRY·May 3, 2011
HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT T8
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code FZX·May 22, 2019
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