9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
SOLO TIES
FDA 510(k)
FDA Class 1
·Dental
Barco
FDA UDI
Barco NV·05415334030343·MDSC-8358 MNAG CA
PCA PUMP
FDA 510(k)
FDA Class 2
·General Hospital
BAYER LIGAND PLUS 1, 2, 3 CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MERIT CUSTOM KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·November 18, 2010
IBOND TOTAL ETCH
FDA Adverse Event
Injury
·HERAEUS KULZER GMBH·Product code KLE·January 9, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 11, 2014
Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2015
Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of cancer.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 2, 2014