9 results
·
22ms
·
Sources: EU EUDAMED, US FDA
8-CHANNEL MULTIPROG IMPLANT SPINAL CORD STIMULATOR
FDA 510(k)
FDA Class 2
·Neurology
NobelProcera HT ML FCZ Implant Bridge and Framework
FDA 510(k)
FDA Class 2
·Dental
NET-2000 MICROCURRENT STIMULATOR
FDA 510(k)
FDA Class 2
·Neurology
CAPSURE SENSE
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
LOCK PERICARDIOCENTESIS CATHETER SET
FDA Adverse Event
Injury
·COOK, INC.·Product code DQO·November 30, 2012
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 22, 2015
Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·October 1, 2025
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
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