15 results
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46ms
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Sources: EU EUDAMED, US FDA
Coach Services Inc. dba Kate Spade c/o Soluciones XB Mexico, S. De R.L. De C.V.
FDA registration
Coach Services Inc. dba Kate Spade c/o Soluciones XB Mexico, S. De R.L. De C.V.·2 products·🇲🇽 Mexico
INTRALASE FS2
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code GEX·March 30, 2026
KATE SPADE BRYLIE RNL 135
FDA Adverse Event
Malfunction
·COACH SERVICES INC. DBA KATE SPADE C/O SOLUCIONES XB MEXICO, S. DE R.L. DE C.V.·Product code HOI·March 27, 2024
KATE SPADE BRYLIE OTQ 135
FDA Adverse Event
Malfunction
·COACH SERVICES INC. DBA KATE SPADE C/O SOLUCIONES XB MEXICO, S. DE R.L. DE C.V.·Product code HOI·March 27, 2024
Varian brand C-Series Clinacs and Acuity, Exact Couch Top, Model Numbers: H69, Product is manufactured and distributed by: Varian Medical Systems Inc., Palo Alto, CA
FDA Recall
Terminated
·Varian Medical Systems Oncology Systems·Product code IYE·April 19, 2010
CyberKnife System Robotic Radiosurgery System, (Standard Treatment Couch) Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185, Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA A Radiation therapy device.
FDA Recall
Terminated
·Accuray Inc·Product code IYE·March 16, 2009
CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard Treatment Couch). Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA
FDA Recall
Terminated
·Accuray Incorporated·Product code IYE·September 12, 2011
Toshiba Aquilion CT System TSX-301A
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAK·May 8, 2015
Toshiba Aquilion CT System TSX-301C
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAK·May 8, 2015
Toshiba Aquilion CT System TSX-301B
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAK·May 8, 2015
Toshiba Aquilion CT System TSX-302A
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAK·May 8, 2015
Toshiba Aquilion CT System TSX-303A
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAK·May 8, 2015
Toshiba Aquilion CT System TSX-101A
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAK·May 8, 2015
Vertical Brake Hubs component of the Philips MX8000 Series Dual v. Exp. Computed Tomography System, Serial Numbers: 8008-8413, 80001-800022, Model #728130, 510 (k) #K010817. Product Usag: The MX 8000 series Dual v. Exp are Computed Tomography X-Ray system units intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code KPS·June 3, 2011
Whole Body X--ray Scanner This device is indicated as a whole body volume CT system. The system produces volumes of up to 320 axial slices in a single rotation.
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAK·July 13, 2009