DeviceClearance

Product code FNJ— General Hospital

AM FAB SIDE RAILS MODEL 5000

Classification name
Bed, Manual
Device class
Class 1
Regulation
21 CFR 880.5120
Advisory panel
General Hospital
Total cleared
39
First cleared
Most recent

Market context for product code FNJ

FDA has cleared 39 devices under product code FNJ between 1976 and 1994, filed by 32 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

Top applicants under product code FNJ

Adverse events under product code FNJ

product code FNJ
Death
6
Total
6

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 FNJ

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