Home › Device types › FFO
Retractor, Self-Retaining
FDA product code FFO · Class 1 · Gastroenterology, Urology
5,155
Registered devices
87
Adverse events
3
Recalls
5
510(k) clearances
Devices with this code
CASPAR CERVICAL ROBOTIC SLIM BLADE — SONTEC INSTRUMENTS, INC.RZ Medizintechnik GmbH — RZ-Medizintechnik GmbHV. Mueller — STERIS CORPORATIONOmni-Tract® — INTEGRA LIFESCIENCES CORPORATIONOmni-Tract® — INTEGRA LIFESCIENCES CORPORATIONSurgical Direct — Surgical Direct, Inc.INTRODUCER SHAFT — SONTEC INSTRUMENTS, INC.Omni-Tract® — INTEGRA LIFESCIENCES CORPORATIONOmni-Tract® — INTEGRA LIFESCIENCES CORPORATIONBookler Table Mounted Retractor Systems — FLEXBAR MACHINE CORPORATIONPILLING — TELEFLEX INCORPORATEDOmni-Tract® — INTEGRA LIFESCIENCES CORPORATIONIntegra® Jarit® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONSurgical Direct — Surgical Direct, Inc.Mediflex Universal Round Bar Table Mounted Retractor Systems — FLEXBAR MACHINE CORPORATIONV. Mueller — STERIS CORPORATIONSurgical Direct — Surgical Direct, Inc.Surgical Direct — Surgical Direct, Inc.V. Mueller — STERIS CORPORATIONMediflex Universal Round Bar Table Mounted Retractor Systems — FLEXBAR MACHINE CORPORATIONSL CONNECT BLADE INSERT HOLDER — SONTEC INSTRUMENTS, INC.Omni-Tract® — INTEGRA LIFESCIENCES CORPORATIONSurgical Direct — Surgical Direct, Inc.Wexler Surgical, Inc. — WEXLER SURGICAL, 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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