12 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DENPAX
FDA 510(k)
FDA Class 1
·Dental
System, Test, Carcinoembryonic Antigen
FDA Pre-Market Approval
FDA Class 2
·ENZYMUN TEST{R} CEA
STELLAR 404T
FDA 510(k)
FDA Class 2
·Cardiovascular
Biomet Variable Pitch Compression Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
BAROUK SCREW - 3 0MM X 32MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HWC·April 7, 2020
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 2014
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·October 31, 2012
VIKING M WIRELESS
FDA Adverse Event
Injury
·LIKO AB·Product code FSA·June 17, 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
IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·March 14, 2018
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