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Allwin Medical Devices, Inc.

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7
Categories6
Latest Approval2023-05-05
TypeNumberDevice NameCodeDate
510(k) K220781 ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter EZN 2023-05-05 View
510(k) K220730 allFlex Ureteral Catheters, Krait Ureteral Catheters KOD 2022-10-13 View
510(k) K203626 SureStrip Vitrification Straw, SureLock Vitrification Straw MQK 2021-06-04 View
510(k) K200248 Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators MQF 2020-07-01 View
510(k) K190659 Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip FAD 2019-12-02 View
510(k) K190590 Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle) MQE 2019-11-25 View
510(k) K190522 Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter) MQF 2019-11-14 View