10 results
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35ms
·
Sources: EU EUDAMED, US FDA
BIS MODULE FOR ENVOY PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Neurology
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 12, 2024
IMPROVED TRY-IN GEL
FDA 510(k)
FDA Class 2
·Dental
PF 5050 PRESSURE UNIT, MODEL PF 5050
FDA 510(k)
FDA Class 2
·Cardiovascular
BD INSULIN PEN NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code FNL·April 22, 2013
OLYMPUS HF-RESECTION ELECTRODE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAS·August 12, 2014
BILIARY BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code FGE·April 28, 2011
PEN NDL 32G 4MM
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·October 15, 2019
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