FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM— 510(k) K050575

Substantially Equivalent

Futumeds Sdn Bhd

FDA 510(k) clearance K050575 for FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM, Substantially Equivalent on 2005-08-15. Applicant: Futumeds Sdn Bhd.

Clearance details

Applicant: Futumeds Sdn Bhd
Product code: Code MDM
Advisory panel: General, Plastic Surgery
Date received: 2005-03-07
Decision date: 2005-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Puchong, MY

Download summary PDF View on FDA.gov ↗

Adverse events under product code MDM

product code MDM

Injury: 247
Malfunction: 1,516
Total: 1,763

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.