Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in AustriaLabelled 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 13, 2026, FDA's public records list Leonhard Lang GmbH with 19 510(k) clearances and 1 device recall. The most recent is a device recall dated Dec 3, 2014: GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2….
| Date | Record | Source |
|---|---|---|
| Dec 3, 2014 | GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and 2059144-005. . Product Usage: UsClass I · The firm discovered that during the use of these defibrillation electrodes a possibility for arcing and a resulting malf | Device recalls |
| Dec 2, 2014 | Skintact, various other tradenamesK142803 · MKJ | 510(k) clearances |
| Jul 29, 2014 | SKINTACTK140500 · GEI | 510(k) clearances |
| May 21, 2014 | SKINTACTK140340 · GXY | 510(k) clearances |
| Feb 8, 2011 | SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODESK103186 · MKJ | 510(k) clearances |
| Aug 21, 2009 | SKINTACT AND VARIOUS OTHER TRADENAMESK092291 · DRX | 510(k) clearances |
| Sep 24, 2008 | SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GELK081371 · MKJ | 510(k) clearances |
| Feb 1, 2008 | SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVEK080106 · DRX | 510(k) clearances |
| Nov 16, 2007 | SKINTACT AND VARIOUS OTHER TRADENAMESK073104 · DRX | 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