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Tenaculum, Uterine

FDA product code HDC · Class 2 · Obstetrics/Gynecology

101
Registered devices
47
Adverse events
8
Recalls
20
510(k) clearances

Devices with this code

Integra® Jarit® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONIntegra® Jarit® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONPILLING — TELEFLEX INCORPORATEDIntegra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONIntegra® Jarit® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONNA — Richard Wolf GmbHRealstar Surgical — REAL STAR SURGICAL INSTRUMENTSPILLING — TELEFLEX INCORPORATEDIntegra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONRealstar Surgical — REAL STAR SURGICAL INSTRUMENTSIntegra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONIntegra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHenry Schein — HENRY SCHEIN, INC.Premier — PREMIER DENTAL PRODUCTS COMPANYV. Mueller — STERIS CORPORATIONIntegra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONIntegra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONIntegra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONSkeane Tenaculum, Slight Curve — GYNEX CORPORATIONBraun Tenaculum, Bariatric — GYNEX CORPORATIONPILLING — TELEFLEX INCORPORATEDV. Mueller — STERIS CORPORATION2-Prong Hook — GYNEX CORPORATIONLiteTouch Schroeder Tenaculum — GYNEX CORPORATION

Recent recalls

DateFirmReason
2021-09-10Stradis Medical, LLC dba Stradis HealthcareFirm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
2021-09-10Stradis Medical, LLC dba Stradis HealthcareFirm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
2021-09-10Stradis Medical, LLC dba Stradis HealthcareFirm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
2021-09-10Stradis Medical, LLC dba Stradis HealthcareFirm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
2021-09-10Stradis Medical, LLC dba Stradis HealthcareFirm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
2021-09-10Stradis Medical, LLC dba Stradis HealthcareFirm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
2014-09-08Instrumed International, Inc.The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and theref
2011-07-29GYN Disposables IncLack of sterility assurance.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.