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SteriLance Medical (Suzhou), Inc.

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K262631 Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)QRK2026-08-25 View
510(k) K260122 Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)QRL2026-07-06 View
510(k) K261634 Disposable Blood Lancet (Soft)QRK2026-06-12 View
510(k) K244031 Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)QRK2025-02-26 View
510(k) K244036 Heel Incision Safety Lancet (SteriHeel 2)FMK2025-02-26 View
510(k) K233796 Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro)FMK2024-01-16 View
510(k) K221521 Disposable Safety LancetFMK2022-10-28 View
510(k) K221507 Disposable Blood LancetQRK2022-08-31 View
510(k) K221970 Lancing deviceQRL2022-08-30 View
510(k) K210745 Heel Incision Safety LancetFMK2021-08-26 View
510(k) K153706 Insulin Pen NeedleFMI2016-08-29 View
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