FZX

Injury

797

Malfunction

3,815

Total

4,612

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 →

• K914715 — PARALLELING GUIDES Implant Corp. of America · 1994-02-16
• K871413 — CIVCO STEPPER CIVCO Medical Instruments Co., Inc. · 1987-07-14
• K871503 — BIOPSY NEEDLE GUIDE KIT, STERILE Amedic USA · 1987-07-10
• K862564 — A.C.L. GUIDE KIT Aspen Laboratories, Inc. · 1986-08-18
• K854262 — MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY Meadox Surgimed, Inc. · 1985-12-24
• K852402 — NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER North American Instrument Corp. · 1985-07-11
• K842698 — BRITISH SPINAL FUSION SET Downs Surgical , Ltd. · 1984-09-12
• K841618 — THREADING TUBE Plastafil, Inc. · 1984-08-27
• K841619 — DRILL GUIDE Plastafil, Inc. · 1984-07-11
• K841297 — TECHMEDICA DRILL GUIDE Techmedica, Inc. · 1984-04-25
• K840835 — STRAITH DRAIN INSERTER Surgical Technology Laboratories, Inc. · 1984-04-23
• K834350 — ACUFEX DREZ COMMUNICATING DRILL GUIDE Acufex Microsurgical, Inc. · 1984-03-19
• K830720 — GRAF MENISCAL SUTURE SET Acufex Microsurgical, Inc. · 1983-06-16
• K821618 — DISPOSABLE NEEDLE HOLDERS Medcare Products · 1982-06-21
• K810888 — BOUNDARY TUBING HOLDERS The Buckeye Cellulose Corp. · 1981-04-23
• K810788 — SURGICAL TUBE HOLDER The Urology Group · 1981-04-17
• K802093 — GABBAY-FRATER SUTURE GUIDE Howmedica Corp. · 1980-09-26
• K792468 — FEEDING TUBE PLACEMENT STYLET Biosearch Medical Products, Inc. · 1979-12-27
• K790872 — ENTERIC TUBE GUIDE Biosearch Medical Products, Inc. · 1979-05-23