12 results
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20ms
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Sources: EU EUDAMED, US FDA
OSTOM-I ALERT
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
Oticon
FDA UDI
Oticon A/S·05711584052020·SENSEI PRO SP, BTE 13 WL 110 EME
RADIAL NAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
THE PL-1064 LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 5, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 13, 2024
TRIATHLON CR X3 TIBIAL INSERT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·June 3, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·June 21, 2011
POLY PER-Q-CATH 5 FR D/L BASIC
FDA Adverse Event
Injury
·C. R. BARD INC. (BASD)·Product code LJS·August 28, 2008
UNID ROD
FDA Adverse Event
Malfunction
·MEDICREA INTERNATIONAL SA·Product code MNI·July 29, 2024
UNID ROD
FDA Adverse Event
Malfunction
·MEDICREA INTERNATIONAL SA·Product code MNI·July 29, 2024
C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·September 24, 2014