14 results
·
35ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
UNIVERSAL TESTING & ANALYSIS SYSTEMS
FDA 510(k)
FDA Class 2
·Neurology
FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DTP401-01, DTP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the brain. The NeuroBlate System components include Gas-cooled Laser Delivery Probes to deliver controlled energy to a target zone.
FDA Enforcement
Class II
·Terminated·Monteris Medical Corp·November 26, 2014
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113249·PS Insert, Size 4 x 14mm
UniTip Catheter
FDA UDI
Unisensor AG·07640172972328·
UniTip Catheter
FDA UDI
Unisensor AG·07640172972311·
UniTip Catheter
FDA UDI
Unisensor AG·07640172972335·
QUANTA LITE CCP ELISA
FDA 510(k)
FDA Class 2
·Immunology
OSSEOSPEED PLUS
FDA 510(k)
FDA Class 2
·Dental
VERSACROSS CONNECT LAAC ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DRE·April 6, 2023
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 9, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 31, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·August 30, 2010
VERSACROSS CONNECT LAAC ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 25, 2023
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal Flexible King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012