10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Surgical Silver Post Operative Dressing
FDA 510(k)
FDA Unclassified
·Unknown
SYNTHES MATRIX SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495
FDA 510(k)
FDA Class 2
·Immunology
BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·June 13, 2018
TMJ BONE SCREW 2.0MM X 8MM
FDA Adverse Event
Injury
·TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS·Product code LZD·May 4, 2023
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·April 26, 2022
SMART CONTROL NITINOL STENT SYSTEM
FDA Adverse Event
Injury
·CORDIS CORPORATION·Product code NIO·October 17, 2014
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 20, 2013
HS III PROXIMAL SEAL SYTEM 3.8MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·May 5, 2011
Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number: 6290-00-703. 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