11 results
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17ms
·
Sources: EU EUDAMED, US FDA
CPK REAGENT SET (COLORIMETRIC)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ASI Mumps IgG EIA Test
FDA UDI
ARLINGTON SCIENTIFIC, INC.·00816057020614·Detection of Mumps antibody
ASI Mumps IgM EIA Test
FDA UDI
ARLINGTON SCIENTIFIC, INC.·00816057020621·Detection of Mumps Antibody
InZone Detachment System
FDA 510(k)
FDA Class 2
·Neurology
MODULAR TROCAR SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
REVO MRI SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWP·June 10, 2014
UNKNOWN STRYKER LEFT KNEE
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·December 4, 2012
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 21, 2010
UNKNOWN
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code GCJ·June 8, 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