11 results
·
25ms
·
Sources: EU EUDAMED, US FDA
INTERLOCKING FEMORAL NAILING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
STERILMED, INC.·10888551007535·SAW BLADE SAGITTAL K9 K2000 SERIES
NA
FDA UDI
STERILMED, INC.·10888551007528·SAW BLADE SAGITTAL K9 K2000 SERIES
Dymaxeon Spine System
FDA 510(k)
FDA Class 2
·Orthopedic
MOBILE MIM
FDA 510(k)
FDA Class 2
·Radiology
TARGET ADAPTER T2 SCN
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·June 21, 2012
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·March 29, 2018
PUMP MMT-722LNAS PRDGM INS SK EN ML
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·November 18, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 14, 2014
SORIN CENTRIFUGAL PUMP 5 (CP5) CONTROL PANEL
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DWA·December 20, 2012
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024