8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AFM ULTRA AG DRESSINGS
FDA 510(k)
FDA Unclassified
·Unknown
TEXAN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30060050
FDA 510(k)
FDA Class 2
·Cardiovascular
PRESS-FIT HEAD RESURFACING DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
SEE H10
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KXA·November 1, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 4, 2013
EON MINI IPG
FDA Adverse Event
Injury
·ST JUDE·Product code GZB·September 9, 2014
ARCHITECT TOTAL B-HCG
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code DHA·May 18, 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