12 results
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25ms
·
Sources: EU EUDAMED, US FDA
MONO ACU-SLIDE TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690190677·Distal Cutting Block
Shoreline ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981132620·Trial 14x13x11mm, 10 Deg Lordosis, w/ Depth Stop
NCB PLATING SYSTEM, PROXIMAL TIBIA PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
Digital Thermometer
FDA 510(k)
FDA Class 2
·General Hospital
SPRINT
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 2014
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·October 4, 2010
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM INC·Product code FNL·November 2, 2012
Various neurology packs
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·September 14, 2022
Various convenience packs
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·September 14, 2022
Various Angiography/Cath Lab packs/trays
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·September 14, 2022
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