Company ยท US
Leonhard Lang GmbH
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2014. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 2, 2014 | K142803 | Skintact, various other tradenames Leonhard Lang GmbH, AT | MKJ |
| Jul 29, 2014 | K140500 | SKINTACT Leonhard Lang GmbH | GEI |
| May 21, 2014 | K140340 | SKINTACT Leonhard Lang GmbH | GXY |
| Feb 8, 2011 | K103186 | SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES Leonhard Lang GmbH | MKJ |
| Aug 21, 2009 | K092291 | SKINTACT AND VARIOUS OTHER TRADENAMES Leonhard Lang GmbH | DRX |
| Sep 24, 2008 | K081371 | SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL Leonhard Lang GmbH | MKJ |
| Feb 1, 2008 | K080106 | SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE Leonhard Lang GmbH | DRX |
| Nov 16, 2007 | K073104 | SKINTACT AND VARIOUS OTHER TRADENAMES Leonhard Lang GmbH | DRX |
| Oct 5, 2007 | K072233 | SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS Leonhard Lang GmbH | MKJ |
| Nov 21, 2006 | K063161 | SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL Leonhard Lang GmbH | GEI |
| Sep 7, 2004 | K041883 | SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21 Leonhard Lang GmbH | MKJ |
| Feb 24, 2004 | K040249 | SKINTACT ECG ELECTRODE Leonhard Lang GmbH | DRX |
| Apr 14, 2003 | K030362 | SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATES Leonhard Lang GmbH | GEI |
| Mar 4, 2003 | K030509 | SKINTACT ECG TAB ELECTRODE Leonhard Lang GmbH | DRX |
| Jan 16, 2003 | K024264 | SKINTACT Leonhard Lang Co. | DRX |
| Jan 16, 2003 | K024247 | SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL Leonhard Lang GmbH | DRX |
| Jan 16, 2003 | K023920 | SKINTACT Leonhard Lang GmbH | DRX |
| Nov 14, 2002 | K023503 | SKINTACT ECG ELECTRODE Leonhard Lang GmbH | DRX |
| Oct 26, 1999 | K982521 | SKINTACT ECG ELECTRODES, S&W ECG ELECTRODES Leonhard Lang Co., AT | DRX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 19, 2014 | Leonhard Lang Gmbh GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and 2059144-005. .
Product Usage: Usage:
Skintact Pediatric Multifunction Electrodes are for use o Terminated |
MKJ | K081371 |
| Sep 24, 2009 | Leonhard Lang Gmbh S&W Electrodes for Defibrillation, 10 Defibrillation Electrodes, Reorder #90101, S & W Healthcare Corp, 1525 Flight Path Drive Brooksville, Florida 34604
The device is non-sterile and single use.
F Terminated |
MKJ | K072233 |
| Sep 24, 2009 | Leonhard Lang Gmbh SKINTACT Electrodes for Defibrillation, 10X REF DF20, Rx only, Manufactured by Leonhard Lang GmbH, Archenweg 56, 6020 Innsbruck, Austria.
The device is non-sterile and single use.
For use on adults Terminated |
MKJ | K072233 |