9 results
·
17ms
·
Sources: EU EUDAMED, US FDA
BACT/ALERT SN
FDA 510(k)
FDA Class 1
·Microbiology
artegral life
FDA UDI
Merz Dental GmbH·D7091993421·anteriors; shade C4; mould UBS
ELECSYS TESTOSTERONE II IMMUNOASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Smart Alarm Interface
FDA 510(k)
FDA Class 2
·Cardiovascular
METRX SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HRX·June 10, 2024
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·March 7, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·August 8, 2014
SPEEDSCREW 5.5 IMPLANT WITH INSERTER HANDLE
FDA Adverse Event
Other
·ARTHROCARE CORP.·Product code HWC·February 10, 2011
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