Leonhard Lang Gmbh

FDA Regulatory Profile

Summary

Total Recalls
1 (1 Class I)
510(k) Clearances
19
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0802-2015Class IGE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 aDecember 3, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K142803Skintact, various other tradenamesDecember 2, 2014
K140500SKINTACTJuly 29, 2014
K140340SKINTACTMay 21, 2014
K103186SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODESFebruary 8, 2011
K092291SKINTACT AND VARIOUS OTHER TRADENAMESAugust 21, 2009
K081371SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GELSeptember 24, 2008
K080106SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVEFebruary 1, 2008
K073104SKINTACT AND VARIOUS OTHER TRADENAMESNovember 16, 2007
K072233SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENOctober 5, 2007
K063161SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GELNovember 21, 2006
K041883SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21September 7, 2004
K040249SKINTACT ECG ELECTRODEFebruary 24, 2004
K030362SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATESApril 14, 2003
K030509SKINTACT ECG TAB ELECTRODEMarch 4, 2003
K023920SKINTACTJanuary 16, 2003
K024247SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GELJanuary 16, 2003
K024264SKINTACTJanuary 16, 2003
K023503SKINTACT ECG ELECTRODENovember 14, 2002
K982521SKINTACT ECG ELECTRODES, S&W ECG ELECTRODESOctober 26, 1999