Belmont Instrument Corporation

FDA Regulatory Profile

Belmont Instrument Corporation appears in FDA public data with 2 recalls, 2 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0153-2023, Class II) was initiated on July 20, 2021. Its most recent 510(k) clearance was granted on September 2, 2015.

Summary

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

Recent Recalls

NumberClassProductDate
Z-0153-2023Class IICritiCool, thermoregulation deviceJuly 20, 2021
Z-0058-2013Class IIBelmont Rapid Infuser, a Fluid Management System, Model FMS2000.September 25, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K152208The Belmont Hyperthermia PumpSeptember 2, 2015
K141654THE BELMONT RAPID INFUSERJuly 18, 2014