9 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DEPUY COMPRESSION HIP SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
da Vinci Xi Surgical System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEPUY CMW 2G 20G
FDA Adverse Event
Malfunction
·DEPUY CMW - 9610921·Product code LOD·December 6, 2022
ATTAIN ABILITY PLUS
FDA Adverse Event
Malfunction
·MPRI·Product code OJX·June 10, 2014
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 4, 2010
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICLA SYSTEMS·Product code MKJ·November 2, 2012
DEPUY CMW 2G 20G
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code LOD·January 12, 2023
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