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Tem Innovations GmbH

FDA Regulatory Profile

Tem Innovations GmbH appears in FDA public data with 0 recalls, 2 510(k) clearances, 2 FDA inspections, and 1 compliance action on record. Its most recent 510(k) clearance was granted on July 8, 2022.

Summary

Total Recalls
0
510(k) Clearances
2
Inspections
2
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K201440ROTEM sigma Thromboelastometry SystemJuly 8, 2022
K101533EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEMAugust 10, 2011

FDA data resources