21 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW, MEDIUM, HIGH
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005
FDA 510(k)
FDA Class 2
·Radiology
TINA-QUANT APOLIPOPROTEIN B VER.2
FDA 510(k)
FDA Class 2
·Immunology
BD PHOENIX¿ SMIC-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 13, 2026
EMAX 2 MOTOR
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·April 11, 2013
PLM LFS PRIM PMP
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·March 22, 2011
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MFK·June 19, 2008
BD PHOENIX¿ SMIC/ID-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·October 16, 2024
BD PHOENIX¿ SMIC/ID-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 1, 2024
BD PHOENIX¿ SMIC-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025
BD PHOENIX¿ SMIC-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025
BD PHOENIX¿ SMIC-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025
BD PHOENIX¿ SMIC/ID-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 8, 2024
BD PHOENIX¿ SMIC/ID-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·December 12, 2024
BD PHOENIX¿ SMIC/ID-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026
BD PHOENIX¿ SMIC/ID-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026
BD PHOENIX¿ SMIC/ID-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026
BD PHOENIX¿ SMIC/ID-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026
Baxter Non-DEHP Micro-Volume Extension Set, product code 2N3348; An Rx sterile, nonpyrogenic fluid pathway, 60'', 0.5mL Vol, with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code FPA·December 15, 2005
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