9 results
·
20ms
·
Sources: EU EUDAMED, US FDA
ELECTRO FLOSS
FDA 510(k)
FDA Class 1
·Dental
Grasping forceps
FDA UDI
SOPRO-COMEG GmbH·04059082023052·
INSPIRATION VENTILATOR SYSTEM 5I/7I
FDA 510(k)
FDA Class 2
·Anesthesiology
CALCIGEN PSI BONE GRAFT SUBSTITUTE
FDA 510(k)
FDA Class 2
·Orthopedic
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·June 22, 2016
TI END CAP WITH T40 STARDRIVE 0MM EXT F/TI TIBIAL NAILS-EX
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code JDS·January 25, 2013
COMBISET WITH BVM
FDA Adverse Event
Malfunction
·REYNOSA MANUFACTURING·Product code FJK·November 22, 2010
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 11, 2014
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