10 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OLYMPUS IGA REAGENT
FDA 510(k)
FDA Class 2
·Immunology
PS CONSTRAINED INSERT XLG
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code JWH·July 20, 2017
KP + LFM
FDA 510(k)
FDA Class 2
·Anesthesiology
NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OMNIGUIDE BEAMPATH FIBER AND ADAPTER
FDA Adverse Event
OMNIGUIDE, INC.·Product code GEX·October 19, 2010
LD304 MATERNITY BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code HDD·April 23, 2013
ARCHITECT IPTH
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code CEW·May 1, 2011
CURRENT RF VR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008
UNK
FDA Adverse Event
Injury
·VISTAKON·Product code LPL·October 11, 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