Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes— 510(k) K211242

Substantially Equivalent

Promisemed Hangzhou Meditech Co., Ltd.

FDA 510(k) clearance K211242 for Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes, Substantially Equivalent on 2021-09-09. Applicant: Promisemed Hangzhou Meditech Co., Ltd..

Clearance details

Applicant: Promisemed Hangzhou Meditech Co., Ltd.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2021-04-26
Decision date: 2021-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou City, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.