Home › Device types › FWZ
Operating Room Accessories Table Tray
FDA product code FWZ · Class 1 · General, Plastic Surgery
3,384
Registered devices
1,802
Adverse events
37
Recalls
61
510(k) clearances
Devices with this code
SchureMed — SCHUERCH CORPORATIONScanlan® SURG-I-BAND® color coding — SCANLAN INTERNATIONAL INCScanlan® SURG-I-BAND® color coding — SCANLAN INTERNATIONAL INCSchureMed — SCHUERCH CORPORATIONFISSO — Baitella AGA Plus — A PLUS INTERNATIONAL INC.SchureMed — SCHUERCH CORPORATIONSchureMed — SCHUERCH CORPORATIONEndoRelease™ Cubital Tunnel System — Ascension Orthopedics, Inc.De Mayo Adapt2Fit® Modular Knee Positioner — Innovative Medical Products, IncKIDNEY AND THORAX HEAD REST 60147 — Merivaara OyNA — Smith & Nephew, Inc.SchureMed — SCHUERCH CORPORATIONDe Mayo D2® Knee Positioner® — Innovative Medical Products, IncTSI — TEDAN SURGICAL INNOVATIONS, L.L.C.Scanlan® SURG-I-BAND® color coding — SCANLAN INTERNATIONAL INCDe Mayo Adapt2Fit® Modular Knee Positioner — Innovative Medical Products, IncNUVO PADS — Medical Illumination International Inc.ALLEN — HILL-ROM, INC.SchureMed — SCHUERCH CORPORATIONALLEN — HILL-ROM, INC.MAYFIELD® — INTEGRA LIFESCIENCES CORPORATIONTSI — TEDAN SURGICAL INNOVATIONS, L.L.C.Cushion — Reison Medical AB
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-02-14 | Baxter Healthcare Corporation | Three lots of the Boot Assembly, Traction Device are being recalled due to due to a customer report of an incorrectly oriented locking pin which caused the boot |
| 2017-03-28 | Mizuho OSI | Mizuho has discovered that the 5319-37 Wilson Frame Pads have a design deficiency in the construction of their mounting sleeves that may allow the patient to co |
| 2015-08-17 | Maquet Cardiovascular Us Sales, Llc | Two serious thromboembolic events were reported involving the Adjustable Positioning Elements (Part Number 1007.28A0) in conjunction with Universal Frame (Part |
| 2015-08-17 | Maquet Cardiovascular Us Sales, Llc | Two serious thromboembolic events were reported involving the Adjustable Positioning Elements (Part Number 1007.28A0) in conjunction with Universal Frame (Part |
| 2014-12-19 | Integra LifeSciences Corporation | Through an investigation of complaints, Integra found that there is the possibility for the locking handle mechanism of the Base Units to fail during use. |
| 2014-10-08 | Customed, Inc | Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inade |
| 2014-10-08 | Customed, Inc | Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inade |
| 2014-10-08 | Customed, Inc | Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inade |
| 2014-10-08 | Customed, Inc | Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing |
| 2014-10-08 | Customed, Inc | Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing |
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