16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·February 15, 2021
CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems
FDA 510(k)
FDA Class 2
·Orthopedic
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code KWP·July 28, 2019
CD HORIZON SOLERA VOYAGER SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·May 27, 2024
CD HORIZON® SOLERA® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC MEDICAL COSTA RICA S.R.L.·Product code KWP·December 30, 2025
CD HORIZON® SOLERA® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC MEDICAL COSTA RICA S.R.L.·Product code KWP·June 10, 2025
TSRH® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC MEDICAL COSTA RICA S.R.L.·Product code NKB·January 22, 2026
BD 1ML SYRINGE LUER-LOK TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·November 23, 2019
SYNAPSE 3D NODULE ANALYSIS
FDA 510(k)
FDA Class 2
·Radiology
DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Injury
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 29, 2018
UNKNOWN FRS SYSTEM
FDA Adverse Event
Injury
·BIOMET TRAUMA·Product code HWC·June 14, 2013
GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DYB·July 12, 2011
ADULT BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·September 16, 2008
24 G X 0.56 IN. BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Injury
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·February 8, 2019
Deltec Cozmo Insulin Pump, model 21-1700. A syringe infusion pump designed for Continuous Subcutaneous Insulin Infusion for the control of diabetes. Reorder Numbers: 21-1701-02/32/33/36/44/49/51/54/62/63/66/81 21-1702-02//49/51 21-1703-02/32/33/36/44/49/51/54/62/63/66/81 21-1704-02/32/33/36/44/49/51/54/62/63/66/81 21-1705-79 21-1706-79 21-1707-79 21-1711-01/02/03/06/14/50 21-1712-01/02 21-1713-01/02/03/06/14/50 21-1714-01/02/03/06/14/50 21-1715-19 21-1716-19 21-1717-19
FDA Recall
Terminated
·Smiths Medical MD, Inc.·Product code LZG·February 22, 2008