Product code HWN— Orthopedic

FDA has cleared 4 devices under product code HWN between 1976 and 1986, filed by 4 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19861 clearance
• 19791 clearance
• 19771 clearance
• 19761 clearance

• Synthes (Usa)1 clearance
• Richard Wolf Medical Instruments Corp.1 clearance
• Richard'S Medical Equip., Inc.1 clearance
• Advanced Ortho-Technology, Inc.1 clearance

Malfunction

586

Total

586

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 →

• K854241 — AOT EXTERNAL COMPRESS DEVICEAdvanced Ortho-Technology, Inc.·1986-03-03
• K792253 — ARICULATED TENSION DEVICE SYNTHES TENSynthes (Usa)·1979-12-05
• K770349 — RIGID TEACHING ATTACHMENTRichard Wolf Medical Instruments Corp.·1977-03-07
• K760970 — FLORIO CPC BANDRichard'S Medical Equip., Inc.·1976-11-23