9 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CONTROL SOLUTIONS INC, MODEL CS3101
FDA 510(k)
FDA Class 2
·Physical Medicine
artegral life
FDA UDI
Merz Dental GmbH·D7091993420·anteriors; shade C4; mould UBM
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198284·AK3 PS Insert Trial Size 4, 20mm
XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
XO Cross Support Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code FNG·March 7, 2013
ACRYSOF IQ TORIC
FDA Adverse Event
Other
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·February 10, 2011
ADAPTA DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·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