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Clinical Innovations, LLC

FDA 510(k) & PMA Approved Devices — 4 products

Total Devices4
Categories4
Latest Approval2025-10-08
TypeNumberDevice NameCodeDate
510(k) K250298 Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S) HDB 2025-10-08 View
510(k) K250897 Koala Intrauterine Pressure Catheter (IPC-5000E) HFN 2025-05-22 View
510(k) K223900 babyLance Safety Heelstick (BLM, BLN, BLP) FMK 2023-02-24 View
510(k) K153591 ebb Complete Tamponade System OQY 2016-01-14 View
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