16 results · 28ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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