7 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KNEEHAB XP CONTROLLER, MODEL 411
FDA 510(k)
FDA Class 2
·Physical Medicine
NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
C.T.M. MOBILITY SCOOTER MODEL # HS-320
FDA 510(k)
FDA Class 2
·Physical Medicine
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code ITI·May 3, 2013
ENVISTA INTRAOCULAR LENS
FDA Adverse Event
Malfunction
·BAUSCH & LOMB, INC.·Product code HQL·August 20, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 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