Blom-Singer Dual Valve Indwelling Voice Prosthesis, Models Dv-1600 Series, Dv-2000 Series

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K082206 ↗

FDA Product Code

EWL

Device Class

Class II

Regulation

21 CFR Part 874.3730

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Blom-Singer Septal Perforation Prosthesis

  Unclassified

  FDA 510(k) K131745 Active Cleared 17 Sep 2013

• Inhealth Blom-Singer Indwelling Plug Insert Accessory Device

  Class II

  FDA 510(k) K945288 Active Cleared 2 Dec 1994

• Blom-Singer Indwelling 2000 Voice Prosthesis

  Class II

  FDA 510(k) K991587 Active Cleared 25 Jun 1999

• Blom-Singer Shower Guard

  Class II

  FDA 510(k) K904729 Active Cleared 28 Feb 1991

• Blom-Singer Humid/Fil Syst Inhealth in-Line Humid.

  Class I

  FDA 510(k) K915786 Active Cleared 30 Jun 1992

• Blom-Singer Indwelling Tep Occluder

  Class II

  FDA 510(k) K093258 Active Cleared 3 Mar 2010

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