DeviceClearance

Product code LGZ— General Hospital

QiF Blood and Fluid Warmer

Classification name
Warmer, Thermal, Infusion Fluid
Device class
Class 2
Regulation
21 CFR 880.5725
Advisory panel
General Hospital
Total cleared
75
First cleared
Most recent

Market context for product code LGZ

FDA has cleared 75 devices under product code LGZ between 1981 and 2026, filed by 49 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code LGZ

Adverse events under product code LGZ

product code LGZ
Death
16
Malfunction
5,916
Other
1
Total
5,933

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code LGZ

Data sourced from openFDA. This site is unofficial and independent of the FDA.