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

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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