9 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENSITE FUSION DYNAMIC REGISTRATION TOOL
FDA 510(k)
FDA Class 2
·Cardiovascular
REBOUND HRD
FDA Adverse Event
Malfunction
·MINNESOTA MEDICAL DEVELOPMENT, INC.·Product code FTL·May 16, 2011
COALIZA PROTEIN S-FREE
FDA 510(k)
FDA Class 2
·Hematology
SOLAR 8000M SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
SOFPORT ADVANCED OPTIC LENS
FDA Adverse Event
Injury
·BAUSCH & LOMB·Product code HQL·April 24, 2013
ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
FDA Adverse Event
Death
·CORDIS NEUROVASCULAR, INC.·Product code NJE·May 10, 2011
HIRES 90K
FDA Adverse Event
Injury
·ADVANCED BIONICS LLC·Product code MCM·July 25, 2008
OPTETRAK LOGIC TIBIAL TRAY
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 6, 2024
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