DeviceClearance

Product code HBB— Neurology

AESCULAP HILAN MOTOR SYSTEM

Classification name
Motor, Drill, Pneumatic
Device class
Class 2
Regulation
21 CFR 882.4370
Advisory panel
Neurology
Total cleared
27
First cleared
Most recent

Market context for product code HBB

FDA has cleared 27 devices under product code HBB between 1989 and 2026, filed by 19 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 HBB

Adverse events under product code HBB

product code HBB
Malfunction
2,656
Total
2,656

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 HBB

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