Pintler Medical LLC

FDA Regulatory Profile

Pintler Medical LLC appears in FDA public data with 1 recall, 1 510(k) clearance, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1139-2019, Class II) was initiated on April 20, 2018. Its most recent 510(k) clearance was granted on August 31, 2012.

Summary

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

Recent Recalls

NumberClassProductDate
Z-1139-2019Class IIA warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad. PPWS-001 indicatApril 20, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K113705PINTLER PATIENT WARMING SYSTEMAugust 31, 2012