2 results
·
11ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers)
FDA Enforcement
Class II
·Terminated·Circulatory Technology Inc·March 7, 2018
AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111; d. Femoral Removal Coring Reamer 9 mm - Long, Model Number CM-7129; e. Femoral Removal Coring Reamer 10 mm - Long, Model Number CM-7130; f. Femoral Removal Coring Reamer 11 mm - Long, Model Number CM-7131; Orthopedic surgical instrument.
FDA Enforcement
Class II
·Terminated·Cayenne Medical Inc.·August 1, 2018