Home › Device types › GDF
Guide, Needle, Surgical
FDA product code GDF · Class 1 · General, Plastic Surgery
873
Registered devices
227
Adverse events
20
Recalls
28
510(k) clearances
Devices with this code
ClosureFast — Covidien LPTemno — CAREFUSION 2200, INCArterial Needle — ARGON MEDICAL DEVICES, INC.Needle Holder — KOROS U.S.A., INC.ALARA® 11 Gauge Access Needle with Sheath Two Pack- Bevel Tip — SURGENTEC, LLCSklar® — SKLAR CORPORATIONTEMNO — CAREFUSION 2200, INCWorking Tube — Joimax GmbHSTOMA® — Storz am Mark GmbHACHIEVE — CAREFUSION 2200, INCCosmoLock Pedicle Screw System — Kalitec Direct LLCSymmetry — ASPEN SURGICAL PRODUCTS, INC.Spider Cervical Plating System — Xtant Medical Holdings, Inc.Needle Holder — KOROS U.S.A., INC.DuaLok™ — Bard Peripheral Vascular, Inc.MaxMoreSpine — Hoogland Spine Products GmbHSTOMA® — Storz am Mark GmbHAutoMark — M.D.L. S.R.L.MaxMoreSpine — Hoogland Spine Products GmbHNeedle Holder — KOROS U.S.A., INC.ClosureFast Arterial Needle — ARGON MEDICAL DEVICES, INC.Needle Holder — KOROS U.S.A., INC.Irix-C Cervical Integrated Fusion System — Xtant Medical Holdings, Inc.Temno — CAREFUSION 2200, INC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-07-07 | Advance Medical Designs, Inc. | Ultrasound gel mislabeled with inappropriate use. |
| 2023-07-07 | Advance Medical Designs, Inc. | Ultrasound gel mislabeled with inappropriate use. |
| 2021-08-05 | M.D.L. S.r.l. | Sterility assurance may be compromised. |
| 2017-03-28 | Bard Peripheral Vascular Inc | It may be at risk of containing a non-MR compatible GHIATAS Beaded Breast Localization Wire instead of a MR compatible GHIATAS Beaded Breast Localization Wire. |
| 2016-08-02 | Hologic, Inc | Tip Breakage at the glue joint between the obturator body and tip |
| 2016-08-02 | Hologic, Inc | Tip Breakage at the glue joint between the obturator body and tip |
| 2016-02-04 | Stryker Instruments Div. of Stryker Corporation | During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible |
| 2016-02-04 | Stryker Instruments Div. of Stryker Corporation | During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible |
| 2016-02-04 | Stryker Instruments Div. of Stryker Corporation | During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible |
| 2016-02-04 | Stryker Instruments Div. of Stryker Corporation | During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible |
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