Home › Device types › GAR
Suture, Nonabsorbable, Synthetic, Polyamide
FDA product code GAR · Class 2 · General, Plastic Surgery
5,555
Registered devices
6,091
Adverse events
14
Recalls
57
510(k) clearances
Devices with this code
Dafilon — B BRAUN SURGICAL SASurgilon — Covidien LPHAVEL'S — Havel's IncorporatedSUTUMED — Unilene S.A.C.FSSB Nylon Suture — FSSB Chirurgische Nadeln GmbHETHILON — ETHICON, LLCUNIFY Cable Nylon Sutures — APPLIED DENTAL, INC.Dafilon — B BRAUN SURGICAL SADemeLON Multi — Demetech CorporationSurgilon — Covidien LPMonosof — Covidien LPDAFILON — B BRAUN SURGICAL SAWEGO-Nylon Non-absorbable Surgical Suture With Needle — Foosin Medical Supplies Inc., Ltd.Henry Schein — HENRY SCHEIN, INC.Monosof — Covidien LPMcKesson — MCKESSON MEDICAL-SURGICAL INC.DemeLON — Demetech CorporationDemeLON — Demetech CorporationTrelon — B BRAUN SURGICAL SADemeLON Multi — Demetech CorporationDemeLON — Demetech CorporationDafilon — B BRAUN SURGICAL SADAFILON — B BRAUN SURGICAL SACROWNJUN Nylon Suture — KONO SEISAKUSHO CO.,LTD.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-24 | Covidien, LP | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to |
| 2025-01-27 | TAS Medical Inc | Tissue approximation straps (zip-ties) have broken before or during implantation so firm developed an interim zip-tie conditioning method submerging zip-ties in |
| 2023-12-21 | Covidien LP | Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over |
| 2022-12-02 | Covidien, LP | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact |
| 2022-12-02 | Covidien, LP | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact |
| 2022-12-02 | Covidien, LP | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact |
| 2022-12-02 | Covidien, LP | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact |
| 2016-08-05 | Riverpoint Medical, LLC | Nylon Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging. |
| 2016-08-05 | Riverpoint Medical, LLC | Polypropylene Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging. |
| 2014-06-13 | Aesculap, Inc. | Aesculap Inc. (AIC (USA)) has initiated a voluntary recall of Dafilon Black 10/0 (0.2) 15 cm DRm4 non-sterile non-absorbable polyamide Surgical Suture due to a |
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.