13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EP -NURSEMATE, EP -NURSEMATE WITH PHYSIO MODULE
FDA 510(k)
FDA Class 2
·Cardiovascular
LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ROSSMAX MEDIPRO MODEL 10 AND 60, MEDICARE MODEL 10 AND 60 BLOOD PRESSURE MONITORS
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 21, 2025
LUX 1440
FDA Adverse Event
Malfunction
·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012
SENSIA DR
FDA Adverse Event
Death
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·May 6, 2013
ACRYSOF RESTOR
FDA Adverse Event
Other
·ALCON RESEARCH, LTD./HUNTINGTON·Product code MFK·April 19, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 5, 2008
PROGREAT
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DQO·March 5, 2024
TERUMO PROGREAT CATHETER
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQO·February 6, 2023
PROGREAT CATHETER
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DQO·January 6, 2024
PROGREAT
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQO·April 15, 2025
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