Medical Device Manufacturer · US , Anaheim , CA

Allwin Medical Devices, Inc.

7 submissions · 6 cleared · Since 2019
7
Total
6
Cleared
0
Denied

Allwin Medical Devices, Inc. — FDA 510(k) Submissions

Allwin Medical Devices, Inc. has submitted 7 FDA 510(k) premarket notifications since 2019, of which 6 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Assisted Reproduction, Needle, Assisted Reproduction, Stent, Ureteral, Labware, Assisted Reproduction, Catheter, Urological . Use the specialty filter in the sidebar to narrow results.

7 devices
1–7 of 7
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
K220781 · EZN Dilator, Catheter, Ureteral · Gastroenterology & Urology
May 2023 414d
allFlex Ureteral Catheters, Krait Ureteral Catheters
K220730 · KOD Catheter, Urological · Gastroenterology & Urology
Oct 2022 213d
SureStrip Vitrification Straw, SureLock Vitrification Straw
K203626 · MQK Labware, Assisted... · Obstetrics & Gynecology
Jun 2021 175d
Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators
K200248 · MQF Catheter, Assisted... · Obstetrics & Gynecology
Jul 2020 152d
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
K190659 · FAD Stent, Ureteral · Gastroenterology & Urology
Dec 2019 263d
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)
K190590 · MQE Needle, Assisted... · Obstetrics & Gynecology
Nov 2019 263d
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)
K190522 · MQF Catheter, Assisted... · Obstetrics & Gynecology
Nov 2019 255d
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