10 results
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19ms
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Sources: EU EUDAMED, US FDA
SCM-400 HOLTER SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
3MATIC
FDA 510(k)
FDA Class 2
·Radiology
MINISCAV
FDA 510(k)
FDA Class 2
·Anesthesiology
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 10, 2014
CONCERTO II CRT-D
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code NIK·October 7, 2010
PINN MULTIHOLE W/GRIPTION 62MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·December 6, 2012
Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
FDA Recall
Open, Classified
·Oto Med Inc·Product code MXP·December 7, 2020
Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
FDA Recall
Open, Classified
·Oto Med Inc·Product code MXP·December 7, 2020
Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
FDA Recall
Open, Classified
·Oto Med Inc·Product code MXP·December 7, 2020
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