Home › Device types › GAX
Tourniquet, Nonpneumatic
FDA product code GAX · Class 1 · General, Plastic Surgery
744
Registered devices
89
Adverse events
8
Recalls
20
510(k) clearances
Devices with this code
Tourniquets — TYPENEX MEDICAL LLCTHE EMERGENCY BANDAGE — EINSTEIN WORKS, LLCAvaline Medical NJ LLC — Avaline Medical NJ Limited Liability CompanyRHINO RESCUE — Wuxi Emsrun Technology Co., Ltd.Bioseal Inc. — BIOSEALEMSRUN — Wuxi Emsrun Technology Co., Ltd.Bioseal Inc. — BIOSEALRhino Rescue — Wuxi Emsrun Technology Co., Ltd.MedSource Tourniquet — MEDSOURCE INTERNATIONAL LLCCuraplex — BOUND TREE MEDICAL, LLCEMSRUN — Wuxi Emsrun Technology Co., Ltd.ZKSK — Beijing ZKSK Technology Co.,LtdBioseal Inc. — BIOSEALDeRoyal — DEROYAL INDUSTRIES, INC.RHINO RESCUE — Wuxi Emsrun Technology Co., Ltd.NAR — NORTH AMERICAN RESCUE, LLCFCP Bandage — FIRST CARE PRODUCTS LTDNOVAPLUS ESMARK V1832 3X12 20/CS — HARTMANN USA, INC.Trinity Sterile, Inc. — Trinity Sterile, Inc.Centurion — CENTURION MEDICAL PRODUCTS CORPORATIONDawnMist — Dukal LLCMarketlab — MARKETLAB INC.DeRoyal — DEROYAL INDUSTRIES, INC.DeRoyal — DEROYAL INDUSTRIES, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-12-28 | Mar-Med Co | A failure can occur if the user attempts to remove the device by partially snipping the edge and pulling on it. The device may tear into two pieces with a porti |
| 2018-05-02 | The Seaberg Company Inc | Based on internal testing, results indicated a possible failure of the stitches securing the buckle to the nylon belt could occur, posing a potential risk when |
| 2018-05-02 | The Seaberg Company Inc | Based on internal testing, results indicated a possible failure of the stitches securing the buckle to the nylon belt could occur, posing a potential risk when |
| 2018-05-02 | The Seaberg Company Inc | Based on internal testing, results indicated a possible failure of the stitches securing the buckle to the nylon belt could occur, posing a potential risk when |
| 2015-08-31 | Pyng Medical Corporation | Once tested, it is required that the tourniquet be returned to its Ready position then placed in its packaging. Each tourniquet was tested for functionality, bu |
| 2014-08-05 | ICU Medical, Inc. | ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility a |
| 2014-08-05 | ICU Medical, Inc. | ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility a |
| 2014-08-05 | ICU Medical, Inc. | ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility a |
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