Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of BayerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 6 spellings of its name, each linked to the record. See the Bayer group view.
As of Nov 15, 2026, FDA's public records list Liebel-Flarsheim Company with 11 drug applications, 3 device recalls, 3 510(k) clearances, 1 drug recall and 1 warning letter. The most recent is a drug recall dated Jul 31, 2026: Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Io….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 31, 2026 | Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile SoClass I · Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass. | Drug recalls |
| Oct 17, 2025 | Warning letter: Sterility assurance, Cleaning validation, Out-of-specificationCDER | Warning letters |
| Mar 11, 2021 | HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)Class II · Failure to comply with the performance standard for fluoroscopy systems. Per 21 CFR 1020.32(k)(6), the displayed AKR and | Device recalls |
| Nov 18, 2020 | Liebel-Flarsheim IBP Transfer SetK193010 · PQH | 510(k) clearances |
| Feb 27, 2017 | Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic proceduClass II · Software issue. The difference between the display and dosimeter readings In the Child/Pediatric automatic exposure mod | Device recalls |
| Feb 27, 2017 | Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procClass II · Software issue. The difference between the display and dosimeter readings In the Child/Pediatric automatic exposure mod | Device recalls |
| Jan 14, 2016 | OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base SystemK152361 · IZQ | 510(k) clearances |
| Jul 11, 2012 | LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEMK121838 · MQB | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
