Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in DenmarkLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of GN Store NordLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list GN Otometrics with 14 510(k) clearances and 2 device recalls. The most recent is a device recall dated Aug 1, 2019: Gold Cup Leadwire and Snap Leadwire with the following component descriptions: 1. 24….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 1, 2019 | Gold Cup Leadwire and Snap Leadwire with the following component descriptions: 1. 24" Snap Leadwire, Blue; 2. 40" Snap Leadwire, BlClass II · The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm. | Device recalls |
| May 28, 2019 | The ICS CHARTR EP 200Class II · There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may res | Device recalls |
| Sep 1, 2016 | Madsen ZodiacK161707 · ETY | 510(k) clearances |
| Nov 16, 2015 | ICS ImpulseK151504 · GWN | 510(k) clearances |
| Oct 23, 2015 | ICS CHARTR EP 200 WITH VEMPK143670 · GWJ | 510(k) clearances |
| Feb 27, 2014 | MADSEN ACCUSCREEN TYPE 1077K132957 · GWJ | 510(k) clearances |
| Feb 1, 2013 | ICS IMPULSEK122550 · GWN | 510(k) clearances |
| Oct 23, 2012 | AURICAL HITK122028 · ETW | 510(k) clearances |
| Sep 27, 2012 | TYPE 1077 ACCUSCREENK122067 · GWJ | 510(k) clearances |
| Apr 28, 2011 | GN OTOMETRICS TYPE 1053 FREEFITK110286 · ETW | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
