Allwin Medical Devices, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 7
- Inspections
- 3
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K220781 | ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, | May 5, 2023 |
| K220730 | allFlex Ureteral Catheters, Krait Ureteral Catheters | October 13, 2022 |
| K203626 | SureStrip Vitrification Straw, SureLock Vitrification Straw | June 4, 2021 |
| K200248 | Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators | July 1, 2020 |
| K190659 | Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/ | December 2, 2019 |
| K190590 | Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup N | November 25, 2019 |
| K190522 | Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Inseminati | November 14, 2019 |