9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SandShark Injectable Anchor (SIA) System
FDA 510(k)
FDA Class 2
·Neurology
1.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S20, VPI.9S50
FDA 510(k)
FDA Class 2
·General Hospital
GUIDEMIA
FDA 510(k)
FDA Class 2
·Radiology
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 19, 2020
27 CM STRAIGHT HEMOSPLIT STANDARD KIT
FDA Adverse Event
Malfunction
·C. R. BARD INC. (BASD)·Product code MSD·July 27, 2011
PRIMEADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 26, 2013
CURLIN
FDA Adverse Event
Malfunction
·CURLIN MEDICAL, INC·Product code FPA·September 25, 2008
CD HORIZON ASTUTE SPINAL SYSTEM
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code NQP·April 16, 2021
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018