RM Temena GmbH

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1609-2014Class IIUltrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box, item number REMarch 19, 2014
Z-1608-2014Class IIUltrasound needles, 22G (0.7 mm) x 50mm, packaged individually, 10 needles/box, item number REF USC0March 19, 2014