8 results
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25ms
·
Sources: EU EUDAMED, US FDA
BACT/ALERT SA
FDA 510(k)
FDA Class 1
·Microbiology
artegral life
FDA UDI
Merz Dental GmbH·D7091993423·anteriors; shade C4; mould UIM
LUNGPOINT PROCEDURE PLANNING
FDA 510(k)
FDA Class 2
·Radiology
VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0
FDA 510(k)
FDA Class 2
·Orthopedic
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·March 7, 2013
DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX
FDA Adverse Event
Other
·APPLIED MEDICAL·Product code FZP·February 10, 2011
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·August 8, 2014
ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer. Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 30, 2015