12 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COMPACTCATH INTERMITTENT URINARY CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017750·K-Wire, Double Ended, Trocar Point, Diameter 0....
OsteoMed
FDA UDI
OSTEOMED LLC·00845694046404·PrimaLIF LLIF PEEK Implant, 9mm X 26mm X 45mm, ...
MODIFICATION TO INFINITY EXPLORER
FDA 510(k)
FDA Class 2
·Cardiovascular
FUSE PLIF CAFE
FDA 510(k)
FDA Class 2
·Orthopedic
NEURAGEN NERVE GUIDE 6MM ID X 3CM LENGTH
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES CORPORATION·Product code JXI·January 5, 2017
EQUINOXE REVERSE SHOULDER COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·July 13, 2023
HEMOSTAR
FDA Adverse Event
Injury
·C.R. BARD, INC. (BASD) -3006260740·Product code MSD·December 27, 2024
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·June 3, 2013
EON 16-CHANNEL RECHARGEABLE IPG
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 21, 2011
9.5 FR D/L CATHETER
FDA Adverse Event
Injury
·C. R. BARD INC. (BASD)·Product code LJS·August 28, 2008
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