DeviceClearance

Product code NEU— General, Plastic Surgery

HydroMARK Breast Biopsy Site Marker

Classification name
Marker, Radiographic, Implantable
Device class
Class 2
Regulation
21 CFR 878.4300
Advisory panel
General, Plastic Surgery
Total cleared
110
First cleared
Most recent

Market context for product code NEU

FDA has cleared 110 devices under product code NEU between 2001 and 2026, filed by 48 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 NEU

Adverse events under product code NEU

product code NEU
Injury
824
Total
824

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 NEU

1–100 of 110

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