21 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Servo-air 4.0 Ventilator System
FDA 510(k)
FDA Class 2
·Anesthesiology
I-LOGIC INREACH SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
LARGE FACE ANEROID SPHYGMOMANOMETER, WALL MODEL, DESK MODEL, MOBILE STAND MODEL, MODEL 41XX, 42XX, 43XX
FDA 510(k)
FDA Class 2
·Cardiovascular
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·June 10, 2020
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 1, 2011
2520274-2013-03830
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·June 27, 2013
ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM
FDA Adverse Event
Death
·MEDTRONIC CARDIOVASCULAR·Product code MIH·October 8, 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
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014