14 results
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18ms
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Sources: EU EUDAMED, US FDA
DETERMINATION OF PHENOBARBITAL
FDA 510(k)
FDA Class 2
·Clinical Toxicology
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690190844·A/P Cutting Block Assy, Open Style Size 6
Kinetic Dynamic Anterior Cervical Plate System
FDA UDI
Life Spine, Inc.·00190837004897·
Ultrasound, Cyclodestructive
FDA Pre-Market Approval
FDA Class 2
·THERAPEUTIC ULTRASOUND FOR TREATMENT OF GLAUCOMA
Elecsys Anti-HBc II
FDA 510(k)
FDA Class 2
·Microbiology
DERMASTREAM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SPRINT QUATTRO
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 2014
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·October 31, 2012
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 17, 2010
IQon Spectral CT Model # 728332, computed tomography x-ray system
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·August 14, 2019
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