10 results
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19ms
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Sources: EU EUDAMED, US FDA
GE DATEX-OHMEDA AISYS CARESTATION
FDA 510(k)
FDA Class 2
·Anesthesiology
AISYS
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code BSZ·January 18, 2016
AISYS
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code BSZ·January 15, 2016
K.E.A.T.
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE
FDA 510(k)
FDA Class 2
·Radiology
PELVISOFT ACELLULAR COLLAGEN BIOMESH
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTM·April 4, 2013
POLYETHYLENE INLAY
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MJO·March 28, 2011
FINELINE II
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008
SROM*STM LG 36+8L 18X13X215N
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LWJ·March 28, 2022
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