9 results
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18ms
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Sources: EU EUDAMED, US FDA
GDC-10 STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-10 2-DIAMETER STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-1
FDA 510(k)
FDA Class 2
·Neurology
artegral life
FDA UDI
Merz Dental GmbH·D7091993415·anteriors; shade C4; mould UCL
Child Malleable Blade
FDA UDI
KOROS U.S.A., INC.·10840199542915·Child Malleable Blade Size 2 x 4-3/4"
physIQ Heart Rhythm and Respiration Module
FDA 510(k)
FDA Class 2
·Cardiovascular
D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT
FDA 510(k)
FDA Class 1
·Microbiology
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·March 7, 2013
PRIDE
FDA Adverse Event
PRIDE MOBILITY PRODUCTS CORPORATION·Product code INI·February 16, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·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