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Sofwave Medical, Ltd.

FDA 510(k) & PMA Approved Devices — 12 products

Total Devices12
Categories2
Latest Approval2025-07-02
TypeNumberDevice NameCodeDate
510(k) K251746 Pure Impact NGX 2025-07-02 View
510(k) K250146 SofWave System NGX 2025-04-18 View
510(k) K241685 SofWave System NGX 2024-08-07 View
510(k) K240687 SofWave System OHV 2024-05-30 View
510(k) K233104 SofWave System OHV 2023-12-22 View
510(k) K232455 SofWave System OHV 2023-12-14 View
510(k) K231537 SofWave System OHV 2023-08-28 View
510(k) K230820 SofWave System OHV 2023-04-18 View
510(k) K230019 SofWave System OHV 2023-03-14 View
510(k) K223237 SofWave System OHV 2022-12-16 View
510(k) K211483 SofWave System OHV 2021-11-15 View
510(k) K191421 Sofacia System OHV 2019-09-09 View
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