Home › Device types › GZB
Stimulator, Spinal-Cord, Implanted (Pain Relief)
FDA product code GZB · Class 2 · Neurology
407
Registered devices
43,932
Adverse events
5
Recalls
139
510(k) clearances
Devices with this code
Freedom System Accessories — Curonix LLCFreedom-8A Spare Kit Channel A US w/ Receiver — STIMWAVE TECHNOLOGIES INCORPORATEDFreedom System Accessory — Curonix LLCNalu Medical, Inc. — NALU MEDICAL, INC.Freedom System Accessories — Curonix LLCFreedom-8A Spare Kit Channel B US w/Receiver — STIMWAVE TECHNOLOGIES INCORPORATEDNalu Medical, Inc. — NALU MEDICAL, INC.Nalu Medical, Inc. — NALU MEDICAL, INC.Nalu Medical, Inc. — NALU MEDICAL, INC.N/A — MEDTRONIC, INC.Freedom System Accessories — Curonix LLCBattery Charger — STIMWAVE TECHNOLOGIES INCORPORATEDFreedom System Accessories — Curonix LLCLead Loop — Suture Concepts Inc.Nalu Medical, Inc. — NALU MEDICAL, INC.Nalu Medical, Inc. — NALU MEDICAL, INC.Nalu Medical, Inc. — NALU MEDICAL, INC.Nalu Medical, Inc. — NALU MEDICAL, INC.Nalu Medical, Inc. — NALU MEDICAL, INC.Nalu Medical, Inc. — NALU MEDICAL, INC.Stimwave Freedom Spinal Cord Stimulation System — STIMWAVE TECHNOLOGIES INCORPORATEDNalu Medical, Inc. — NALU MEDICAL, INC.Nalu Medical, Inc. — NALU MEDICAL, INC.NA — MEDTRONIC, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-07-29 | St. Jude Medical, Inc. | The Directions for Use (DFU) manual contains information for devices that are not approved in the US. The correct US approved versions of the manuals were sent |
| 2014-07-29 | St. Jude Medical, Inc. | The Directions for Use (DFU) manual contains information for devices that are not approved in the US. The correct US approved versions of the manuals were sent |
| 2010-02-22 | Advanced Neuromodulation Systems, Inc | Directions For Use of product incorrectly stated lead compatibility information. |
| 2008-05-21 | Medtronic Neuromodulation | Medtronic is recalling certain lots of Model 3998 SPECIFY surgical lead kits due to a package mislabeling issue. The package labeling incorrectly states the le |
| 2005-11-22 | Medtronic Inc, Neurological & Spinal Division | A limited number of Model 37711 Restore Neurostimulators have an incorrect internal memory parameter that causes the device to indicate it is fully recharged wh |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.