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Gag, Mouth

FDA product code KBN · Class 1 · Ear, Nose, Throat

1,016
Registered devices
47
Adverse events
1
Recalls
3
510(k) clearances

Devices with this code

BR Surgical, LLC — BR Surgical, LLCHNM MEDICAL — HNM STAINLESS, LLC.Bausch + Lomb — Bausch & Lomb IncorporatedIntegra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONN/A — BIOMET MICROFIXATION, INCMILLENNIUM — Avalign Technologies, Inc.RZ Medizintechnik GmbH — RZ-Medizintechnik GmbHMedicon — Medicon eG. Chirurgiemechaniker-GenossenschaftAESCULAP — AESCULAP, INC.Adler Instrument Company — Adler, Inc.Snowden-Pencer — CAREFUSION 2200, INCMSI Precision Specialty Instruments — Med Saver, Inc.devemed — devemed GmbHMOUTH PROP MOLT MOUTH GAG-ADULT (WITHOUT TUBING) — W.H. Holden, Inc.HNM MEDICAL — HNM STAINLESS, LLC.Medicon — Medicon eG. Chirurgiemechaniker-GenossenschaftIntegra® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONMicroFrance® — INTEGRA MICROFRANCEIntegra® Ruggles®-Redmond™ — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONReicodent — devemed GmbHMOUTH PROP BITE BLOCKS CHLD/ADULT 10"BLK — W.H. Holden, Inc.JEDMED — JEDMED INSTRUMENT COMPANYTBS Dental — ACME ENTERPRISE.Bausch + Lomb — Bausch & Lomb Incorporated

Recent recalls

DateFirmReason
2018-02-16Aesculap Implant Systems LLCThe plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.

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