TMD 0.5ML SAFETY SYRINGE (FA18 SERIES 0.5ML/FA58 SERIES U-100 INSULIN/FA78 SERIES TUBERCULIN)— 510(k) K042426

Name: FDA 510(k) clearance K042426
Creator: U.S. Food and Drug Administration
Published: 2004-09-22

Substantially Equivalent

Taiject Medical Device Co., Ltd.

FDA 510(k) clearance K042426 for TMD 0.5ML SAFETY SYRINGE (FA18 SERIES 0.5ML/FA58 SERIES U-100 INSULIN/FA78 SERIES TUBERCULIN), Substantially Equivalent on 2004-09-22. Applicant: Taiject Medical Device Co., Ltd.. Device class: 2.

Clearance details

Applicant: Taiject Medical Device Co., Ltd.
Product code: Code MEG
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2004-09-08
Decision date: 2004-09-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Newport Beach, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MEG

product code MEG

Malfunction: 1,373
Other: 1
Total: 1,374

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.