BSN Medical
Charlotte, NC, US
BSN MEDICAL appears in FDA device records in Charlotte, NC. FDA records list 3 510(k) clearances between and , no PMA records and 7 registered establishments. 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 3 510(k) clearances for BSN Medical between 2012 and 2015. The busiest year on record is 2012, with 1. The most recent is 2015, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2013 | 1 |
| 2015 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K143151 | Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact) | FRO | Substantially Equivalent | |
| K131496 | BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE) | DWL | Substantially Equivalent | |
| K123561 | ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS | DWL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9615780 | 3003747474 | BSN MEDICAL | 1 Rue Du Millenaire, VIBRAYE Sarthe 72320 FR | 2026 | |
| 9710608 | 3003441980 | BSN MEDICAL GMBH | HEYKENAUKAMP 10, HAMBURG D-21147 DE | 2026 | |
| 3005121802 | 3005121802 | BSN MEDICAL INC. | 400 OLMOS BLVD, SUITE A, Hidalgo, TX 78557 US | 2026 | |
| 1038963 | 1038963 | BSN MEDICAL, INC. | 5825 CARNEGIE BLVD., CHARLOTTE, NC 28209 US | 2026 | and 16 more, listed in full below |
| 3017297225 | 3017297225 | BSN Medical GmbH | Schutzenstrasse 1-3, Hamburg 22761 DE | 2026 | and 16 more, listed in full below |
| 3007141284 | 3007141284 | BSN medical Inc. | 1011 Keisler Road, Conover, NC 28613 US | 2026 | |
| 1043537 | 1043537 | BSN medical inc. | 1555 4th Ave SE, Hickory, NC 28602 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IKXAid, Transfer
- ISRBand Or Belt, Pelvic Support
- ITGBandage, Cast
- FQMBandage, Elastic
- NECBandage, Liquid, Skin Protectant
- HEFBinder, Breast
- MDRBinder, Medical, Therapeutic
- LGFComponent, Cast
- KIACover, Cast
- FRODressing, Wound, Drug
- NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic
- NACDressing, Wound, Hydrophilic
- NADDressing, Wound, Occlusive
- NABGauze / Sponge,Nonresorbable For External Use
- LGGInstrument, Cast Application/Removal, Manual
- LGHInstrument, Cast Removal, Ac-Powered
- ITWJoint, Ankle, External Brace
- ITQJoint, Knee, External Brace
- KTDOrthosis, Abdominal
- IQKOrthosis, Cervical
- IQIOrthosis, Limb Brace
- IQEOrthosis, Lumbar
- IPYOrthosis, Lumbo-Sacral
- IPXOrthosis, Rib Fracture, Soft
- IMEPack, Hot Or Cold, Reusable
- HMPPad, Eye
- FMPProtector, Skin Pressure
- IPGShoe, Cast
- JOWSleeve, Limb, Compressible
- ILISling, Arm
- ILESling, Arm, Overhead Supported
- IQJSplint, Clavicle
- NOCSplint, Extremity, Non-Inflatable, External, Non-Sterile
- ILHSplint, Hand, And Components
- FQLStocking, Medical Support (For General Medical Purposes)
- DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)
- IOYSupport, Arm
- EXNSupport, Hernia
- KGXTape And Bandage, Adhesive
- PYKVenous Ulcer Kit
- KGNWound Dressing With Animal-Derived Material(S)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1228-2022 | (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 are packaged into a folding box. Shipping case contains 10 folding boxes. (2) JOBST Compri2 lite, REF 76271-02, containing 2 components, one plastic-wrapped padding (as is contained in REF 76271-01) and one plastic wrapped compression bandage with a compression of approximately 20-30mmHg packaged into a pouch and then both components are packaged into a folding box. Shipping case contains 10 folding boxes. | The folding boxes within the shipping case are mislabeled. The shipping case and immediate packages within the folding boxes are correctly labeled. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain