9 results
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26ms
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Sources: EU EUDAMED, US FDA
HAMILTON-T1,HAMILTON-C1
FDA 510(k)
FDA Class 2
·Anesthesiology
Oticon
FDA UDI
Oticon A/S·05711584052037·DYNAMO SP10, BTE 13 WL 110 SGR
INTELLIVUE PATIENT MONITOR MODEL: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 AND MP90
FDA 510(k)
FDA Class 2
·Cardiovascular
SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
FDA 510(k)
FDA Class 2
·Orthopedic
SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER W/AMC THROMBOSHIELD
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DYG·June 3, 2013
ASR UNI FEMORAL IMPL SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·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
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
C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·December 11, 2013