12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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iFuse TORQ® Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
MRI MARKER
FDA 510(k)
FDA Class 2
·Radiology
DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CONTOUR® PLUS BLUE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 13, 2025
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·July 22, 2011
PETITE PACING LEAD
FDA Adverse Event
Malfunction
·OSCOR INC.·Product code DTB·October 14, 2014
PELVICOL 2 X 4 CM
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE ...·Product code FTL·July 12, 2013
CONTOUR® PLUS BLUE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·February 11, 2025
CONTOUR® CARE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·June 13, 2025
CONTOUR® CARE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 7, 2025
REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Medium, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·March 19, 2014
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022