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Retractor, Self-Retaining
FDA product code FFO · Class 1 · Gastroenterology, Urology
5,125
Registered devices
86
Adverse events
3
Recalls
5
510(k) clearances
Devices with this code
Omni-Tract® — INTEGRA LIFESCIENCES CORPORATIONKMEDIC — TELEFLEX INCORPORATEDSurgical Direct — Surgical Direct, Inc.Surgical Direct — Surgical Direct, Inc.Surgical Direct — Surgical Direct, Inc.Surgical Direct — Surgical Direct, Inc.Bookler Table Mounted Retractor Systems — FLEXBAR MACHINE CORPORATIONSurgical Direct — Surgical Direct, Inc.Surgical Direct — Surgical Direct, Inc.Quinelato — Schobell Industrial LtdaHayden Medical — Hayden Medical, Inc.Surgical Direct — Surgical Direct, Inc.Mini-Bookler Table Mounted Retractor Systems — FLEXBAR MACHINE CORPORATIONOmni-Tract® — INTEGRA LIFESCIENCES CORPORATIONOmni-Tract® — INTEGRA LIFESCIENCES CORPORATIONSurgical Direct — Surgical Direct, Inc.Surgical Direct — Surgical Direct, Inc.CASPAR CERVICAL STANDARD BLADE — SONTEC INSTRUMENTS, INC.Sklar® — SKLAR CORPORATIONGalaxy II Surgical Retractor — MOSAIC SURGICAL LIMITEDBookler Table Mounted Retractor Systems — FLEXBAR MACHINE CORPORATIONRZ Medizintechnik GmbH — RZ-Medizintechnik GmbHSurgical Direct — Surgical Direct, Inc.Surgical Direct — Surgical Direct, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2015-11-25 | Abeon Medical Corporation | The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product. |
| 2015-11-25 | Abeon Medical Corporation | The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product. |
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