7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
SURGICAL KNIVES & PROBES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
AIR SOLFY, MODELS AS-4H, AS-4H-O, AS-4H-V, AS-4H-OV, AS-1,AS-1-0,AS-1-V, AS-1-OV
FDA 510(k)
FDA Class 1
·Dental
Safety Auto-Disable Syrine with Needle (Auto-Lock)
FDA 510(k)
FDA Class 2
·General Hospital
EXTENSION SET WITH T-CONN. SL
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code FPA·March 14, 2014
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 19, 2012
ALARIS
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·September 3, 2010
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·April 10, 2013