5 results
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11ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)
FDA Recall
Terminated
·AGFA Corp.·Product code LLZ·August 8, 2006
LumiWave 1X4 Infrared Therapy Device, Catalog # LW1X4, BioCare Systems, Inc.
FDA Recall
Terminated
·Biocare Systems Inc.·Product code ILY·June 14, 2006
VariSource AL13198000, Intralumenal Kit
FDA Recall
Terminated
·Alpha Omega Services Inc·Product code JAQ·February 21, 2006
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
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