10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ELECTROCARDIOGRAPH CONTINUOUS MONITOR
FDA 510(k)
FDA Class 2
·Neurology
AYSAM
Device
EU MDD
·
Eu Md Class 2b
·Aysam Ortopedi ve Tıbbi Aletler Sanayi ve Ticaret Limited Şirketi·On the market·1 country
QUADROSTAR 532
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch
FDA 510(k)
FDA Class 2
·Microbiology
CAPSUREFIX
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 10, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·November 5, 2012
EON MINI IPG, 16-CHANNEL RECHARGEABLE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 22, 2015
10MM/130 DEG TI CANN TROCH FIXATION NAIL 235MM-STERILE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·April 24, 2018
TIBIA KANULLU INTRAMEDULLER CIVI CELIK (TIBIA CANNULLATED INTRAMEDULLARY NAIL SS) 8 X 280 MM
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Aysam Ortopedi ve Tıbbi Aletler Sanayi ve Ticaret Limited Şirketi·1 device
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012