Leonhard Lang Medizintechnik GmbH
FDA Regulatory Profile
Summary
- Total Recalls
- 4 (2 Class I)
- 510(k) Clearances
- 0
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-3109-2017 | Class I | Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. Product Usage: Multifu | August 8, 2017 |
| Z-0004-2017 | Class I | Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for extern | September 1, 2016 |
| Z-0292-2016 | Class II | ECG Electrodes: 50007 Stablebase SBW55 50675 Stablebase SBW55-15 58051 Skintact W-60 505 | November 2, 2015 |
| Z-1350-2015 | Class II | Skintact ECG Electrode FS-50, Catalog no. 58028 , & Stable Base ECG Electrode SBT-60, Catalog no. | February 24, 2015 |