14 results · 19ms · Sources: EU EUDAMED, US FDA

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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