7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PARA TECH PLUS RETICS
FDA 510(k)
FDA Class 2
·Hematology
AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE
FDA 510(k)
FDA Class 2
·Physical Medicine
LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/LEFT
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code JDP·March 8, 2013
EON RECHARGEABLE IPG, 16-CHANNEL
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·January 13, 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