TOCOLYTIC SITE CARE SUP KIT #1001/100A/CARRY CASE— 510(k) K893003

Unknown

United Medical Systems, Inc.

FDA 510(k) clearance K893003 for TOCOLYTIC SITE CARE SUP KIT #1001/100A/CARRY CASE, Unknown on 1989-07-14. Applicant: United Medical Systems, Inc..

Clearance details

Applicant
United Medical Systems, Inc.
Product code
Code FOZ
Advisory panel
General Hospital
Date received
Decision date
Decision
Unknown
Clearance type
Traditional
Location
Santa Ana, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code FOZ

product code FOZ
Death
38
Injury
2,290
Malfunction
25,858
Other
11
Total
28,197

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.