9 results
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19ms
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Sources: EU EUDAMED, US FDA
VOROBA TECHNOLOGIES, ASSOC. QUANTUM HEARING AID
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
PREMIER® Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00681490482349·PLATE 6860170 70 MM ANTERIOR CERVICAL
ORTHOMED
FDA UDI
ORTHO-MED, INC.·B8038601700·NERVE RETRACTOR SHORT
Lehman Manometry Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·June 10, 2014
24FR 90? CUTTING LOOP ELECTRODE , .012 (6BX)
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY·Product code HIH·November 1, 2012
UNKNOWN NEXGEN LPS-FLEX FEMORAL COMPONENT
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code HSA·September 21, 2010
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