Electrode, Needle
Regulation 882.1350
0510(k)s in 12 months (53 all time)
0recalls in 12 months (21 all time)
21recalls that name a 510(k)
Top companies in GXZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Stryker Instruments Div. of Stryker Corporation | 0 | 19 |
| Rhythmlink International, LLC | 5 | 0 |
| Technomed Europe | 4 | 1 |
| Cadwell Laboratories, Inc. | 4 | 0 |
| Axon Systems, Inc. | 2 | 0 |
| Class A Ent. | 2 | 0 |
| The Electrode Store, Inc. | 2 | 0 |
| Ives Eeg Solutions, Inc. | 2 | 0 |
| Medicotest, Inc. | 2 | 0 |
| Neuroinvent, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 8, 2021 | Technomed Europe Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001. Terminated |
GXZ | K130136 |
| Sep 3, 2010 | Stryker Instruments Div. of Stryker Corporation 24G x 25mm/45 Bevel Single Shot Needle, REF 554-024-025, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI. Terminated |
GXZ | K990100 |
| Sep 3, 2010 | Stryker Instruments Div. of Stryker Corporation 22G x 70mm/45 Bevel Single Shot Needle, REF 554-022-070, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI. Terminated |
GXZ | K990100 |
| Sep 3, 2010 | Stryker Instruments Div. of Stryker Corporation 22G x 50mm/45 Bevel Single Shot Needle, REF 554-022-050, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI. Terminated |
GXZ | K990100 |
| Sep 3, 2010 | Stryker Instruments Div. of Stryker Corporation 21G x 150mm Stimulation Catheter Continuous Nerve Block Tray, REF 554-021-150, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI. Terminated |
GXZ | K990100 |
| Sep 3, 2010 | Stryker Instruments Div. of Stryker Corporation 21G x 90mm/45 Bevel Single Shot Needle, REF 554-021-090, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI. Terminated |
GXZ | K990100 |
| Sep 3, 2010 | Stryker Instruments Div. of Stryker Corporation 17G x 150mm Stimulation Catheter Continuous Nerve Block Tray, REF 553-318-150, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI. Terminated |
GXZ | K990100 |
| Sep 3, 2010 | Stryker Instruments Div. of Stryker Corporation 17G x 90mm Stimulation Catheter Continuous Nerve Block Tray, REF 553-318-090, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI. Terminated |
GXZ | K990100 |
| Sep 3, 2010 | Stryker Instruments Div. of Stryker Corporation 17G x 150mm Stimulation Catheter Continuous Nerve Block Tray, REF 553-318-050, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI. Terminated |
GXZ | K990100 |
| Sep 3, 2010 | Stryker Instruments Div. of Stryker Corporation 17G x 150mm Tuohy Stimulation Catheter Kit, REF 553-218-150, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI. Terminated |
GXZ | K990100 |
| Sep 3, 2010 | Stryker Instruments Div. of Stryker Corporation 17G x 90m Tuohy Stimulation Catheter Kit, REF 553-218-90, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI. Terminated |
GXZ | K990100 |
| Sep 3, 2010 | Stryker Instruments Div. of Stryker Corporation 17G x 50m Tuohy Catheter Kit, REF 553-218-50, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI. Terminated |
GXZ | K990100 |
| Sep 3, 2010 | Stryker Instruments Div. of Stryker Corporation 18G x 150m Tuohy Catheter Kit, REF 553-118-150, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI. Terminated |
GXZ | K990100 |
| Sep 3, 2010 | Stryker Instruments Div. of Stryker Corporation 18G x 90mm/20 Tuohy Catheter Kit, REF 553-118-090, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI. Terminated |
GXZ | K990100 |
| Sep 3, 2010 | Stryker Instruments Div. of Stryker Corporation 18G x 50mm/20 Tuohy Catheter Kit, REF 553-118-050, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI. Terminated |
GXZ | K990100 |
| Sep 3, 2010 | Stryker Instruments Div. of Stryker Corporation 24G x 25mm/20 bevel Single Shot Needle, REF 552-024-025, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI. Terminated |
GXZ | K990100 |
| Sep 3, 2010 | Stryker Instruments Div. of Stryker Corporation 22G x 70mm/20 bevel Single Shot Needle, REF 552-022-70, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI. Terminated |
GXZ | K990100 |
| Sep 3, 2010 | Stryker Instruments Div. of Stryker Corporation 21G x 150m/20 bevel Single Shot Needle, REF 552-021-150, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI. Terminated |
GXZ | K990100 |
| Sep 3, 2010 | Stryker Instruments Div. of Stryker Corporation 22G x 50m/20 bevel Single Shot Needle, REF 552-022-050, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI. Terminated |
GXZ | K990100 |
| Sep 3, 2010 | Stryker Instruments Div. of Stryker Corporation 21G x 90mm/20 Bevel Single Shot Needle, REF 55-021-090, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI. Terminated |
GXZ | K990100 |
| Jul 25, 2006 | Nicolet Biomedical Div of Viasys Healthcare VIASYS Healthcare Disposable Bar Electrodes. Re-order No. 019-435600. Single Use only. Manufactured in the U.S.A. for VIASYS Healthcare, 5225 Verona Road, Bldg 2, Madison, WI USA 53711-4495..Each Terminated |
GXZ | K010019 |
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