Company ยท US
LIEBEL-FLARSHEIM COMPANY LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2020. Name variants (Inc, Corp, punctuation) are merged.
3510(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 |
|---|---|---|---|
| Nov 18, 2020 | K193010 | Liebel-Flarsheim IBP Transfer Set Liebel-Flarsheim Company, LLC | PQH |
| Jan 14, 2016 | K152361 | OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System Liebel-Flarsheim Company, LLC | IZQ |
| Jul 11, 2012 | K121838 | LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM Liebel-Flarsheim | MQB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 11, 2021 | LIEBEL-FLARSHEIM COMPANY LLC HydraVision Digital Imaging System
Product ID/Reorder Number: 705559 (65KW) Terminated |
MQB | K121838 |
| Feb 27, 2017 | LIEBEL-FLARSHEIM COMPANY LLC Liebel-Flarsheim Direct Digital Imaging System (DDIS)
Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primaril Terminated |
MQB | K121838 |
| Feb 27, 2017 | LIEBEL-FLARSHEIM COMPANY LLC Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR)
Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, prima Terminated |
IXR | K943581 |