510(k) K990100 ยท GXZ Electrode, Needle
POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE
| Applicant | Te ME NA S.A.R.L., Oldsmar FL, US |
| Decision | Substantially Equivalent, Aug 2, 2000 |
| Received | Jan 4, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990100
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.