ARTHRO-Pump PA304— 510(k) K173311

Substantially Equivalent

W.O.M. World of Medicine GmbH

FDA 510(k) clearance K173311 for ARTHRO-Pump PA304, Substantially Equivalent on 2018-05-09. Applicant: W.O.M. World of Medicine GmbH.

Clearance details

Applicant: W.O.M. World of Medicine GmbH
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2017-10-18
Decision date: 2018-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berlin, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.