DeviceClearance

Product code FMT— General Hospital

GIRAFFE AND PANDA WARMERS

Classification name
Warmer, Infant Radiant
Device class
Class 2
Regulation
21 CFR 880.5130
Advisory panel
General Hospital
Total cleared
92
First cleared
Most recent

Market context for product code FMT

FDA has cleared 92 devices under product code FMT between 1979 and 2025, filed by 51 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 FMT

Adverse events under product code FMT

product code FMT
Death
4
Malfunction
3,074
Total
3,078

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 FMT

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