DeviceClearance

Product code FMQ— General Hospital

PATIENT RESTRAINTS

Classification name
Restraint, Protective
Device class
Class 1
Regulation
21 CFR 880.6760
Advisory panel
General Hospital
Total cleared
134
First cleared
Most recent

Market context for product code FMQ

FDA has cleared 134 devices under product code FMQ between 1976 and 2011, filed by 46 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 FMQ

Adverse events under product code FMQ

product code FMQ
Death
8
Total
8

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 FMQ

1–100 of 134

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