9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Arthrex Minimally Invasive Ankle Fusion Plate
FDA 510(k)
FDA Class 2
·Orthopedic
ZOLL IVTM COOL LINE CATHETER
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION INC·Product code NCX·April 22, 2024
TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK
FDA 510(k)
FDA Class 2
·Neurology
MICROLIFE NON-CONTACT INFRARED FOREHEAD THERMOMETER, MODEL FR1DZ1
FDA 510(k)
FDA Class 2
·General Hospital
ZOLL IVTM COOL LINE CATHETER
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION·Product code NCX·February 29, 2024
OSCILLATING SAW ATTACHMENT
FDA Adverse Event
Malfunction
·SYNTHES OBERDORF·Product code HWE·October 21, 2014
IMPL-HOLDER F/PLIVIOS REVOLUTION SST
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·June 26, 2013
EON RECHARGEABLE IPG
FDA Adverse Event
Malfunction
·ST JUDE NEDICAL - NEUROMODULATION·Product code LGW·July 19, 2011
Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number: 6290-00-702. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter.
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·September 10, 2014