21 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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XW-100 Automated Hematology Analyzer for CLIA Waived Use
FDA 510(k)
FDA Class 2
·Hematology
I-LOGIC INREACH SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
DUO TEMP
FDA 510(k)
FDA Class 2
·Dental
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·June 10, 2020
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 19, 2023
ULTRAPRO MESH
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·June 17, 2013
BIOLOX CERAMIC HEAD
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·July 19, 2011
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·September 19, 2008
CD HORIZON® FENESTRATED SCREW SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·September 3, 2024
CD HORIZON® SOLERA¿ FENESTRATED SCREW SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code NKB·July 28, 2025
CD HORIZON® SOLERA¿ FENESTRATED SCREW SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code NKB·July 28, 2025
CD HORIZON® SOLERA¿ FENESTRATED SCREW SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·April 2, 2025
CD HORIZON® SOLERA® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., HU·Product code NKB·March 20, 2026
CD HORIZON® SOLERA¿ FENESTRATED SCREW SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code MNI·December 9, 2025
CD HORIZON® SOLERA¿ FENESTRATED SCREW SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·April 16, 2024
CD HORIZON® SOLERA FENESTRATED SCREW SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·November 4, 2022
CD HORIZON® SOLERA¿ FENESTRATED SCREW SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·December 2, 2024
CD HORIZON® SOLERA¿ FENESTRATED SCREW SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·June 10, 2025
CD HORIZON SOLERA FENESTRATED SCREW SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·November 3, 2022
CD HORIZON SOLERA FENESTRATED SCREW SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·January 30, 2025