K001293

Substantially Equivalent

MODIFICATION TO MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PRE-ATTACHED NEEDLE

Applicant: Medimop Medical Projects, Ltd.
Product code: LHI
Advisory panel: General Hospital
Date received: 2000-04-24
Decision date: 2000-05-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Washington, DC, US

Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.