14 results
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19ms
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Sources: EU EUDAMED, US FDA
UROVYSION BLADDER CANCER RECURRENCE KIT
FDA 510(k)
FDA Class 2
·Immunology
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496013785·MARILYN 70 SHEER, SIZE S, FUMO, GRADUATED COMPR...
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033542538·
EXCELSIOR MICROCATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code DQY·April 13, 2010
NOVEL PRINT CYAN ALGINATES
FDA 510(k)
FDA Class 2
·Dental
KSEA DION-GRACIA SET
FDA 510(k)
FDA Class 2
·Cardiovascular
EXCELSIOR MICROCATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code DQY·May 18, 2010
EXCELSIOR MICROCATHETER
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - CORK·Product code DQY·August 2, 2010
IMMERSION HYDROBATH
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ILJ·March 20, 2013
CONTINUOUS NERVE BLOCK KIT
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code CAZ·February 4, 2011
ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT OTW
FDA Adverse Event
Injury
·MEDTRONIC CARIDOVASCULAR GALWAY·Product code NIQ·March 14, 2008
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
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022