DeviceClearance

Product code MDM— General, Plastic Surgery

ACU-DISPO-CE(TM)

Classification name
Instrument, Manual, Surgical, General Use
Device class
Class 1
Regulation
21 CFR 878.4800
Advisory panel
General, Plastic Surgery
Total cleared
44
First cleared
Most recent

Market context for product code MDM

FDA has cleared 44 devices under product code MDM between 1980 and 2008, filed by 37 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

last 15 years

Top applicants under product code MDM

Adverse events under product code MDM

product code MDM
Injury
247
Malfunction
1,516
Total
1,763

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 MDM

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