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Guide, Needle, Surgical
FDA product code GDF · Class 1 · General, Plastic Surgery
877
Registered devices
228
Adverse events
20
Recalls
28
510(k) clearances
Devices with this code
Philips — Philips Medical Systems Nederland B.V.Gimmi — Gimmi GmbHNeedle Holder — KOROS U.S.A., INC.STOMA® — Storz am Mark GmbHSilex Sacroiliac Joint Fusion System — Xtant Medical Holdings, Inc.Retractor Blade — Joimax GmbHAPTUS — Medartis AGMark — M.D.L. S.R.L.MaxMoreSpine — Hoogland Spine Products GmbHTEMNO — CAREFUSION 2200, INCNeedle Holder — KOROS U.S.A., INC.SeeStar — Apriomed ABSTOMA® — Storz am Mark GmbHNeedle Holder — KOROS U.S.A., INC.ClosureFast — Covidien LPCHESBROUGH® — Bard Peripheral Vascular, Inc.Needle Holder — KOROS U.S.A., INC.ACHIEVE — CAREFUSION 2200, INCSTOMA® — Storz am Mark GmbHAPTUS — Medartis AGDeRoyal — DEROYAL INDUSTRIES, INC.OmniClose trocar site closure device — UNIMAX MEDICAL SYSTEMS INC.Titanium Catroviejo Curved Needle Holder, With Lock — KATALYST SURGICAL LLCNeedle Holder — KOROS U.S.A., 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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