Bellus Medical, LLC
Johnson City, TN, US
BELLUS MEDICAL, LLC appears in FDA device records in Johnson City, TN. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Bellus Medical, LLC in 2018.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010392991 | 3010392991 | BELLUS MEDICAL, LLC | 207 Mockingbird Ln, Johnson City, TN 37604 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- PQDBlood Specimen Collection Convenience Kit (Excludes Hiv)
- JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- MECDisinfector, Medical Devices
- NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic
- GAANeedle, Aspiration And Injection, Disposable
- FMINeedle, Hypodermic, Single Lumen
- ORGPlatelet And Plasma Separator For Bone Graft Handling
- QAIPowered Microneedle Device
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0660-2020 | SKINFUSE Resuce Calming Complex Kit containing: SKINFUSE LIFT HG - Product Usage: The SKINFUSE Rescue Calming Complex is intend to be used to soothe and calm skin (cosmetic). The SKINFUSE LIFT HG is a hydrogel wound dressing to protect against abrasion and friction during the microneedling procedure. | Cosmetic Kit was packaged with a mislabel medical product. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain