RM Temena GmbH

FDA Regulatory Profile

RM Temena GmbH appears in FDA public data with 2 recalls, 0 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1609-2014, Class II) was initiated on March 19, 2014.

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