11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPIRA Open Matrix ALIF
FDA 510(k)
FDA Class 2
·Orthopedic
LATERAL FUSION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
MEDTRONIC GRAFT DELIVERY SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
CONSULTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·October 10, 2014
TECNIS
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQL·June 11, 2013
MINICAP TRANSFER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 15, 2011
DEKA MOTUS AX
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·October 25, 2018
DEKA MOTUS AX
FDA Adverse Event
Malfunction
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·March 9, 2023
DEKA MOTUS AX
FDA Adverse Event
Malfunction
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·February 6, 2024
Philips Zenition 70, Model Number: 718133
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024
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