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Amsino International, Inc.

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

Total Devices11
Categories7
Latest FDA decision2026-05-04
TypeNumberDevice NameCodeDateActions
510(k) K252543 AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)FPA2026-05-04 View
510(k) K220230 AMSure Enteral Feeding PumpLZH2022-11-10 View
510(k) K220267 AMSafe NeuFlo Needleless ConnectorFPA2022-10-07 View
510(k) K213522 AMSafe Pre-Filled Normal Saline Flush SyringeNGT2022-03-22 View
510(k) K200051 PUGGLE Enteral Feeding Pump and Feeding SetLZH2020-09-25 View
510(k) K183473 AMSafe(R) Pre-Filled Normal Saline Flush SyringeNGT2019-07-12 View
510(k) K181445 AMSure Hydrophilic Intermittent CatheterEZD2018-10-01 View
510(k) K181423 AMSure Sterile Water, and Sterile Normal Saline for Wound FlushFRO2018-09-07 View
510(k) K173665 AMSafe Sure-Lok Needle-Free ConnectorFPA2018-09-05 View
510(k) K181814 AMSure Pre-filled Syringe for Balloon Inflation with Sterile WaterEZL2018-09-04 View
510(k) K171857 AMSure® Enteral Feeding Syringe with ENFit TipPNR2018-03-30 View