9 results
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25ms
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Sources: EU EUDAMED, US FDA
RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540
FDA 510(k)
FDA Class 2
·Microbiology
PREMIER® Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00681490482240·PLATE 6860145 45 MM ANTERIOR CERVICAL
ORTHOMED
FDA UDI
ORTHO-MED, INC.·B8038601450·INFERO-POSTERIOR ACETABULAR CAP RETRACTOR 10" LEFT
Full Automatic (NIBP) Blood Pressure Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
FDS INTIMATE AND INTIMATE WARMING LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VIVA XT
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2014
PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM HIP
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code FQH·November 21, 2012
IRM ZOE INTERMEDIATE RESTORATIVE MATERIAL
FDA Adverse Event
Injury
·DENTSPLY CAULK·Product code EMA·June 18, 2015
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