16 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496042969·SLIMMING SLEEVES, SIZE M, CHAMPAGNE, GRADUATED ...
CARTO XP SYSTEM
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, LTD·Product code DQK·November 30, 2007
CARTO XP EP NAVIGATION SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)·Product code DQK·August 14, 2008
DOUBLE SPRINGERS NONOXNOL 9 CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8
FDA 510(k)
FDA Class 2
·Neurology
CARTO XP EP NAVIGATION SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER LTD. (HAIFA, ISREAL)·Product code DQK·April 17, 2008
CD HORIZON LEGACY MINI SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS, INC.·Product code MNI·February 3, 2012
HEARTSTART FRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 4, 2013
EXTERNAL PADDLES
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·March 30, 2011
ENDOTAK ENDURANCE RX
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·December 19, 2023
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·August 3, 2022
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·February 16, 2023
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·April 25, 2023
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