CellEra, LLC
Monroe, OH, US
CellEra, LLC appears in FDA device records in Monroe, OH. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007594734 | 3007594734 | CellEra, LLC | 1045 Reed Road, Monroe, OH 45050 US | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NECBandage, Liquid, Skin Protectant
- FRODressing, Wound, Drug
- NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic
- NACDressing, Wound, Hydrophilic
- NADDressing, Wound, Occlusive
- LFRGlucose Dehydrogenase, Glucose
- FQHLavage, Jet
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- NBWSystem, Test, Blood Glucose, Over The Counter
- KGNWound Dressing With Animal-Derived Material(S)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0805-2022 | 20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box | Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU. | Class III | Terminated | |
| Z-0804-2022 | 20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box | Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU. | Class III | Terminated | |
| Z-0803-2022 | 20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box | Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU. | Class III | Terminated | |
| Z-0802-2022 | 20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box | Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU. | Class III | Terminated | |
| Z-0801-2022 | 20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box | Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU. | Class III | Terminated | |
| Z-2085-2019 | VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144 | Adhesive border was not sticky enough. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain