Company ยท US
Allwin Medical Devices, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2026. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 9, 2026 | K261234 | The D-Tip Denudation Pipette Allwin Medical Devices, Inc. | MQH |
| May 5, 2023 | K220781 | ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator Allwin Medical Devices, Inc. | EZN |
| Oct 13, 2022 | K220730 | allFlex Ureteral Catheters, Krait Ureteral Catheters Allwin Medical Devices, Inc. | KOD |
| Jun 4, 2021 | K203626 | SureStrip Vitrification Straw, SureLock Vitrification Straw Allwin Medical Devices, Inc. | MQK |
| Jul 1, 2020 | K200248 | Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators Allwin Medical Devices, Inc. | MQF |
| Dec 2, 2019 | K190659 | Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatri Allwin Medical Devices, Inc. | FAD |
| Nov 25, 2019 | K190590 | Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Allwin Medical Devices, Inc. | MQE |
| Nov 14, 2019 | K190522 | Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED Allwin Medical Devices, Inc. | MQF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||