Blue Belt Technologies MN

FDA Regulatory Profile

Blue Belt Technologies MN appears in FDA public data with 4 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1943-2014, Class II) was initiated on June 4, 2014.

Summary

Total Recalls
4
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1943-2014Class IIStride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesisJune 4, 2014
Z-1942-2014Class IIStride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unicondylar Knee prosthesisJune 4, 2014
Z-1575-2014Class IINavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.April 11, 2014
Z-1995-2013Class IIBlue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product UsaJuly 19, 2013