DeviceClearance

Product code BSZ— Anesthesiology

GE DATEX-OHMEDA AISYS

Classification name
Gas-Machine, Anesthesia
Device class
Class 2
Regulation
21 CFR 868.5160
Advisory panel
Anesthesiology
Total cleared
189
First cleared
Most recent

Market context for product code BSZ

FDA has cleared 189 devices under product code BSZ between 1976 and 2026, filed by 72 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 BSZ

Adverse events under product code BSZ

product code BSZ
Death
23
Injury
298
Malfunction
32,987
Total
33,308

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 BSZ

1–100 of 189

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