18 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Shoulder Innovations Total Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic
MICROPLEX COIL SYSTEM- COSMOS
FDA 510(k)
FDA Class 2
·Cardiovascular
INREACH SYSTEM, MODEL AAS00161-02
FDA 510(k)
FDA Class 2
·Radiology
INTELLAMAP ORION?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·May 12, 2026
INTELLAMAP ORION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 15, 2025
INTELLAMAP ORION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 29, 2026
INTELLAMAP ORION?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 17, 2026
GORILLA/BABY GORILLA PLATING SYSTEM
FDA Adverse Event
Injury
·PARAGON 28, INC·Product code HRS·September 17, 2020
ACCU-CHEK ® AVIVA COMBO
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·October 22, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 27, 2013
OT DELICA LANCING DEVICE
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·August 4, 2011
INTELLAMAP ORION?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·January 30, 2026
INTELLAMAP ORION?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 1, 2026
INTELLAMAP ORION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·November 21, 2024
INTELLAMAP ORION?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·February 26, 2026
INTELLAMAP ORION
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·December 12, 2024
PEDICLE SCREW 03.50.054 PEDICLE SCREW 8X40MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·June 16, 2023
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018