Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Belmont Instrument with 22 510(k) clearances and 8 device recalls. The most recent is a device recall dated Jul 20, 2021: CritiCool, thermoregulation device.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 20, 2021 | CritiCool, thermoregulation deviceClass II · Premature pump failure may lead to the device displaying a HALT 4 error, from which the device cannot recover even after | Device recalls |
| Sep 2, 2015 | The Belmont Hyperthermia PumpK152208 · LGZ | 510(k) clearances |
| Jul 18, 2014 | THE BELMONT RAPID INFUSERK141654 · FRN | 510(k) clearances |
| Nov 6, 2013 | BELMONT HYPERTHERMIA PUMPK131519 · LGZ | 510(k) clearances |
| Sep 25, 2012 | Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.Class II · Leak from a saline bag caused saline to drip along the back of the Rapid infuser close to the Power Entry Module causin | Device recalls |
| Nov 16, 2011 | THE BELMONT BUDDY LITE FLUID WARMERK112639 · BSB | 510(k) clearances |
| Jul 1, 2009 | THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000K091855 · FRN | 510(k) clearances |
| Mar 26, 2009 | THE BELMONT BUDDY LITE FLUID WARMERK090508 · BSB | 510(k) clearances |
| Feb 12, 2009 | BELMONT HYPERTHERMIA PUMPK090089 · LGZ | 510(k) clearances |
| Jun 8, 2007 | HYPERTHERMIA PUMPK070654 · LGZ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
