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Tenaculum, Uterine

FDA product code HDC · Class 2 · Obstetrics/Gynecology

101
Registered devices
48
Adverse events
8
Recalls
20
510(k) clearances

Devices with this code

Integra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONIntegra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONLLETZ Iris Hook — GYNEX CORPORATIONRealstar Surgical — REAL STAR SURGICAL INSTRUMENTSNA — Richard Wolf GmbHSchroeder Tenaculum, Double Tooth — GYNEX CORPORATIONIntegra® Jarit® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONIntegra® Jarit® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONRealstar Surgical — REAL STAR SURGICAL INSTRUMENTSTeale Tenaculum, Slight Curve — GYNEX CORPORATIONBraun Tenaculum — GYNEX CORPORATIONBraun Tenaculum, Bariatric — GYNEX CORPORATIONIntegra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONIntegra® Jarit® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONRealstar Surgical — REAL STAR SURGICAL INSTRUMENTSRealstar Surgical — REAL STAR SURGICAL INSTRUMENTSV. Mueller — STERIS CORPORATIONIntegra® Jarit® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONRealstar Surgical — REAL STAR SURGICAL INSTRUMENTSLLETZ Braun Tenaculum — GYNEX CORPORATIONNA — Richard Wolf GmbHAESCULAP — AESCULAP, INC.Premier — PREMIER DENTAL PRODUCTS COMPANYIntegra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION 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.