12 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
AVALON ELITE VASCULAR ACCESS KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
MICOR ANESTHESIA CONDUCTION KIT
FDA 510(k)
FDA Class 2
·Anesthesiology
HOWMEDICA OSTEONICS ZIRCONIA-TOUGHENED-ALUMINA (BIOLOX DELTA) CERAMIC FEMORAL HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HTO·August 3, 2018
DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HTO·May 29, 2015
SHAVER BLADE AGGRESSIVE PLUS FORMULA SERIES RED/BLUE
FDA Adverse Event
Malfunction
·STERILMED, INC.·Product code HRX·June 27, 2019
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code MCM·April 29, 2013
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 5, 2011
BIPOL LEAD MODEL 300
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·July 23, 2008
BLUNT TIP SCREW, 4X40MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·February 3, 2023
DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HTO·October 28, 2016
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015