Home › Device types › GCC
Dilator, Catheter
FDA product code GCC · Class 1 · General, Plastic Surgery
196
Registered devices
73
Adverse events
5
Recalls
5
510(k) clearances
Devices with this code
HNM Medical — HNM STAINLESS, LLC.HNM MEDICAL — HNM STAINLESS, LLC.HNM MEDICAL — HNM STAINLESS, LLC.HNM Medical — HNM STAINLESS, LLC.NA — BOSTON SCIENTIFIC CORPORATIONHNM Medical — HNM STAINLESS, LLC.HNM MEDICAL — HNM STAINLESS, LLC.Cook — COOK INCORPORATEDMillennium — Avalign Technologies, Inc.Novo Surgical Inc — NOVO SURGICAL, INC.HNM Medical — HNM STAINLESS, LLC.HNM Medical — HNM STAINLESS, LLC.Screw Dilator — ARGON MEDICAL DEVICES, INC.HNM Medical — HNM STAINLESS, LLC.NA — BOSTON SCIENTIFIC CORPORATIONByrd — Cook Vandergrift Inc.Novo Surgical Inc. — NOVO SURGICAL, INC.HNM MEDICAL — HNM STAINLESS, LLC.Screw Dilator — ARGON MEDICAL DEVICES, INC.HNM MEDICAL — HNM STAINLESS, LLC.Percutaneous Nephrostomy Dilator — Well Lead Medical Co.,LtdAXS INFINITY LS PLUS — Stryker CorporationHNM Medical — HNM STAINLESS, LLC.Novo Surgical — NOVO SURGICAL, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-07-31 | DePuy Spine, Inc. | Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. |
| 2013-07-31 | DePuy Spine, Inc. | Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. |
| 2013-07-31 | DePuy Spine, Inc. | Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. |
| 2013-07-31 | DePuy Spine, Inc. | Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. |
| 2013-07-31 | DePuy Spine, Inc. | Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. |
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.
