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MEDIVISION
MEDIVISION, INC. · Model MVA470 · UDI-DI 00851328007109
10
510(k) clearances
25,683
Adverse events (36 deaths)
126
Recalls
382
Facilities
Description
ARTHROSCOPE Intended use of MediVision Arthroscope is for orthopedic use in the knee, shoulder, wrist (carpal ligament release), temporal-mandibular joint, ankle, elbow, and plantar fascia release. SINUSCOPE Intended use of MediVision Sinuscope is to allow direct visualization (through the Sinuscope or the video monitor) of the nasal cavity.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-02-11 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may |
| 2024-10-11 | Karl Storz Endoscopy | Due to holes detected in the inner barrier system that may compromise the sterility of the affected products. |
| 2024-05-24 | WOM World Of Medicine AG | Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery |
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma |
| 2021-05-17 | ADRIA SRL | The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed. |
| 2021-05-17 | ADRIA SRL | The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed. |
| 2021-05-17 | ADRIA SRL | The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed. |
| 2021-01-19 | ReNovo, Inc. | Non-sterile product was shipped to customers labelled as sterile. |
| 2020-06-24 | Smith & Nephew, Inc. | The T-Fix sterile package contains only one sleeve instead of two, The device will not perform as intended for the second bone tunnel due to the absence of thesleeve |
| 2020-04-24 | Medtronic Sofamor Danek USA Inc | Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may incre |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.