Leonhard Lang Gmbh
FDA Regulatory Profile
Leonhard Lang Gmbh appears in FDA public data with 1 recall — including 1 Class I (most serious) —, 19 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0802-2015, Class I) was initiated on December 3, 2014. Its most recent 510(k) clearance was granted on December 2, 2014.
Summary
- Total Recalls
- 1 (1 Class I)
- 510(k) Clearances
- 19
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0802-2015 | Class I | GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 a | December 3, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K142803 | Skintact, various other tradenames | December 2, 2014 |
| K140500 | SKINTACT | July 29, 2014 |
| K140340 | SKINTACT | May 21, 2014 |
| K103186 | SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES | February 8, 2011 |
| K092291 | SKINTACT AND VARIOUS OTHER TRADENAMES | August 21, 2009 |
| K081371 | SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL | September 24, 2008 |
| K080106 | SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE | February 1, 2008 |
| K073104 | SKINTACT AND VARIOUS OTHER TRADENAMES | November 16, 2007 |
| K072233 | SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFEREN | October 5, 2007 |
| K063161 | SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL | November 21, 2006 |
| K041883 | SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21 | September 7, 2004 |
| K040249 | SKINTACT ECG ELECTRODE | February 24, 2004 |
| K030362 | SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATES | April 14, 2003 |
| K030509 | SKINTACT ECG TAB ELECTRODE | March 4, 2003 |
| K024264 | SKINTACT | January 16, 2003 |
| K023920 | SKINTACT | January 16, 2003 |
| K024247 | SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL | January 16, 2003 |
| K023503 | SKINTACT ECG ELECTRODE | November 14, 2002 |
| K982521 | SKINTACT ECG ELECTRODES, S&W ECG ELECTRODES | October 26, 1999 |