DeviceClearance

K081814

Substantially Equivalent

REPROCESSED ENT SHAVERS

Applicant
Sterilmed, Inc.
Product code
ERL
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Maple Grove, MN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code ERL

product code ERL
Malfunction
11,234
Total
11,234

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 →

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