Data / Medical devices / United States / BSN medical Inc.
BSN medical Inc.: FDA-registered device maker in Conover, NC, United States, 5 510(k) clearances
BSN medical Inc. is registered with the FDA (registration 3007141284) in Conover, NC, United States. It lists 10 device types. The FDA files 5 510(k) clearances under its listings, the newest dated November 6, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007141284
- Address
- 1011 Keisler Road, Conover, NC, United States, 28613
- Owner or operator
- BSN medical GmbH (9047426)
- Roles
- Repackager or relabeler
- First device listed
- November 21, 1992
- Registered through
- 2026
- Brand names listed
- AO Cast Saw, AO Cast Vacuum, Actimove Professional Line PowerMotion Calf support, Actimove Professional Line PowerMotion Thigh support, Actimove Sports Edition Shoulder Support Extra Pocket for Optional Hot/Cold Pack, Actimove Sports Edition Thigh Support Adjustable, Activa, Aquacast Liner and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Cast | ITG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Cast Application/Removal, Manual | LGG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Cast Removal, Ac-Powered | LGH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Orthosis, Limb Brace | IQI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Repackager or relabeler | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Stocking, Medical Support (For General Medical Purposes) | FQL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | DWL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 6, 2019 | K190268 | Hydrofera Blue READY - Border | FRO | Substantially Equivalent | Hydrofera, LLC | accessdata.fda.gov |
| January 2, 2014 | K130670 | HYDROFERA BLUE PU BACTERIOSTATIC DRESSING | FRO | Substantially Equivalent | Hydrofera, LLC | accessdata.fda.gov |
| January 26, 2011 | K103187 | TRIPLEPLAY-VT VASCULAR THERAPY SYSTEM | JOW | Substantially Equivalent | Wildcat Medical, Inc. | accessdata.fda.gov |
| January 11, 2002 | K013462 | HYDROFERA BACTERIOSTATIC WOUND DRESSING | FRO | Substantially Equivalent | Hydrofera, LLC | accessdata.fda.gov |
| May 18, 1995 | K951234 | MEDICAL SUPPORT STOCKINGS | DWL | Substantially Equivalent | Jobst A Beiersdorf Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Drug
- All makers of Instrument, Cast Removal, Ac-Powered
- All makers of Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
- All makers of Bandage, Cast
- All makers of Instrument, Cast Application/Removal, Manual
- All makers of Tape And Bandage, Adhesive
Updated November 6, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.