DeviceClearance

Product code HDB— Obstetrics/Gynecology

MITYVAC

Classification name
Extractor, Vacuum, Fetal
Device class
Class 2
Regulation
21 CFR 884.4340
Advisory panel
Obstetrics/Gynecology
Total cleared
30
First cleared
Most recent

Market context for product code HDB

FDA has cleared 30 devices under product code HDB between 1977 and 2025, filed by 17 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 HDB

Adverse events under product code HDB

product code HDB
Death
7
Total
7

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 HDB

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