LIEBEL-FLARSHEIM COMPANY LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 2
- Inspections
- 12
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1992-2021 | Class II | HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW) | March 11, 2021 |
| Z-2834-2018 | Class II | Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitat | February 27, 2017 |
| Z-2833-2018 | Class II | Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim urology systems facili | February 27, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K193010 | Liebel-Flarsheim IBP Transfer Set | November 18, 2020 |
| K152361 | OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOn | January 14, 2016 |