Mederi Therapeutics, Inc

FDA Regulatory Profile

Mederi Therapeutics, Inc appears in FDA public data with 1 recall, 2 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2050-2017, Class II) was initiated on April 3, 2017. Its most recent 510(k) clearance was granted on September 23, 2015.

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2050-2017Class IIMederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. April 3, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K152317Stretta CatheterSeptember 23, 2015
K103017MEDERI THERAPEUTICS RF GENERATOR CONTROL MODULEJanuary 20, 2011