Data / Medical devices / United States / BSN medical Inc.
BSN medical Inc.: FDA-registered device maker in Charlotte, NC, United States, 3 510(k) clearances
BSN medical Inc. is registered with the FDA (registration 1038963) in Charlotte, NC, United States. It lists 26 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 20, 1999. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1038963
- Address
- 11405 North Community House Road Suite 600, Charlotte, NC, United States, 28277
- Owner or operator
- BSN medical GmbH (9047426)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 27, 1983
- Registered through
- 2026
- Brand names listed
- , Jobst Comprifore #2, ACTIMOVE KIDS WRIST STABILIZER, REMOVABLE METAL STAY, LEFT OR RIGHT, ACTIMOVE POST-OP ROM KNEE BRACE, ACTIMOVE PROFESSIONAL LINE MANUS, WRIST STABILIZER, AO Cast Saw, AO Cast Vacuum, Actimove Alufoam, Actimove Arthritis Care Ankle Support and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aid, Transfer | IKX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Band Or Belt, Pelvic Support | ISR | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Bandage, Cast | ITG | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Bandage, Elastic | FQM | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Binder, Breast | HEF | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Binder, Medical, Therapeutic | MDR | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Component, Cast | LGF | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Cover, Cast | KIA | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Instrument, Cast Application/Removal, Manual | LGG | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Instrument, Cast Removal, Ac-Powered | LGH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Joint, Ankle, External Brace | ITW | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Joint, Knee, External Brace | ITQ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthosis, Cervical | IQK | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthosis, Limb Brace | IQI | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthosis, Lumbar | IQE | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthosis, Lumbo-Sacral | IPY | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Sling, Arm | ILI | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Splint, Hand, And Components | ILH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Stocking, Medical Support (For General Medical Purposes) | FQL | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | DWL | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Support, Hernia | EXN | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Venous Ulcer Kit | PYK | 1 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| August 20, 1999 | K991570 | JOBST READY-TO-WEAR ARM SLEEVES | DWL | Substantially Equivalent | Beiersdorf-Jobt, Inc. | accessdata.fda.gov |
| May 18, 1995 | K951234 | MEDICAL SUPPORT STOCKINGS | DWL | Substantially Equivalent | Jobst A Beiersdorf Co. | accessdata.fda.gov |
| April 4, 1994 | K925154 | JOBST-CUSTOM | DWL | Substantially Equivalent | Jobst Institute, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 1, 2022 | 89530 | Class II | Terminated | (1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped padding and one plastic-wrapped compression bandage with compression of approximately 40 mmHg packaged into a pouch and then both components a | The folding boxes within the shipping case are mislabeled. The shipping case and immediate packages within the folding boxes are correctly labeled. | accessdata.fda.gov |
Compare with other makers
- All makers of Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
- All makers of Joint, Knee, External Brace
- All makers of Splint, Extremity, Non-Inflatable, External, Non-Sterile
- All makers of Orthosis, Lumbo-Sacral
- All makers of Orthosis, Limb Brace
- All makers of Support, Hernia
Updated August 20, 1999. 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.