9 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ICI P AND S SERIES IR CAMERAS
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
PRECISION NOVI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 3, 2020
COMFORT AGILE SCOOTER, LY-EW303
FDA 510(k)
FDA Class 2
·Physical Medicine
CORDIS AVIATOR PERIPHERAL DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
LUX 1440
FDA Adverse Event
Malfunction
·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code BTI·April 23, 2013
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MFK·April 27, 2011
RIATA ST ACTIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008
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