16 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GO GO ELITE TRAVELLER PLUS 4 WHEEL SCOOTER, MODEL SC54
FDA 510(k)
FDA Class 2
·Physical Medicine
DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Neurology
PORTA GEO TI
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 17, 2025
GLADIATOR?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code LIT·April 17, 2013
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code MIH·June 19, 2008
ICC 300
FDA Adverse Event
ERBE USA, INC·Product code GEI·April 12, 2011
ALINITY I HAVAB IGM REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LOL·March 26, 2026
CORMATRIX ECM FOR PERICARDIAL CLOSURE
FDA Adverse Event
Injury
·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·October 26, 2011
CORMATRIX ECM FOR PERICARDIAL CLOSURE
FDA Adverse Event
Injury
·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·October 30, 2013
CORMATRIX ECM FOR PERICARDIAL CLOSURE
FDA Adverse Event
Injury
·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·April 14, 2015
CORMATRIX ECM FOR PERICARDIAL CLOSURE
FDA Adverse Event
Injury
·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·May 7, 2010
CORMATRIX ECM FOR PERICARDIAL CLOSURE
FDA Adverse Event
Injury
·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·July 19, 2013
BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS)
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Company·July 27, 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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015