7 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EXTREMITY MEDICAL COMPRESSION SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO MEDSTATION
FDA 510(k)
FDA Class 2
·Radiology
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX
FDA 510(k)
FDA Class 2
·Immunology
CANNULATED 4.0MM HEXAGONAL SCREWDRIVER
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code HXX·April 29, 2013
XACT CAROTID STENT SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR·Product code NIM·July 23, 2008
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 5, 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