262 results
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48ms
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Sources: EU EUDAMED, US FDA
MUCheck®
FDA UDI
Oncology Data Systems Inc·00860175002403·MUCheck® Independent Dose Calculation Software....
DAVINCI
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·June 15, 2022
ENDOWRIST
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·June 15, 2022
Eclipse Radiation Treatment Planning System, model H48; Varian Medical Systems Inc..
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code MUJ·May 3, 2011
BrachyVision software, catalog #AL15521003, CD-ROM (set of four) packaged in plastic sleeve and inserted into Varian Medical Systems Imaging Products Vision binder. Labeled in part ***Varian Medical Systems Inc. Oncology Systems***
FDA Recall
Terminated
·Varian Brachytherary Virginia·Product code LNX·October 31, 2003
VITROS ECI IMMUNODIAGNOSTIC SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code KHO·September 20, 2011
DA VINCI
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·May 6, 2026
DA VINCI
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·March 17, 2026
Clinac, Trilogy. Trilogy Tx and Novalis Tx Linear Accelerators. Varian Medical Systems, Inc. Oncology Systems Intended for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions in the body where radiation treatment is indicated.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·May 26, 2011
DAVINCI XI
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·June 1, 2023
DAVINCI XI
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·July 15, 2022
Clinac Linear Accelerator; Model numbers H14, H27 and H29. Product Usage: Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·May 18, 2011
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·October 14, 2022
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·October 14, 2022
DA VINCI SI SURGICAL SYSTEM
FDA Adverse Event
Death
·INTUITIVE SURGICAL,INC.·Product code NAY·October 30, 2015
TrueBeam Linear Accelerators (aka Trilogy Mx) Varian Medical Systems, Palo Alto, CA Product Usage: Intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors , and conditions anywhere in the body where radiation treatment is indicated.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·May 19, 2011
DA VINCI
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·March 17, 2026
Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code MUJ·January 28, 2013
UNIVERSAL STUMP APPLICATOR SET
FDA Adverse Event
Injury
·VARIAN MEDICAL SYSTEMS INC., ONCOLOGY SYSTEMS·Product code JAQ·December 11, 2017
4DITC
FDA Adverse Event
Malfunction
·VARIAN MEDICAL SYSTEMS, INC. ONCOLOGY SYSTEMS·Product code IYE·January 26, 2011