FDA 510(k) Applications Submitted by Yan Li

FDA 510(k) Number Submission Date Device Name Applicant
K103407 11/19/2010 COTRONIC DIGITAL THERMOMETER COTRONIC MANUFACTURING
K180291 02/01/2018 Cook Silicone Balloon HSG Catheter Cook Incorporated
K220679 03/08/2022 Pediatric Nailing Platform Femur OrthoPediatrics Corp.
K220809 03/21/2022 Drive Rail System OrthoPediatrics Corp.
K231266 05/02/2023 Pediatric Nailing Platform Tibia OrthoPediatrics Corp.
K171810 06/19/2017 Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter Cook Incorporated
K201838 07/02/2020 PediFlex Flexible Nail System OrthoPediatrics Corp.
K202319 08/17/2020 Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) Tianjin Huahong Technology Co., Ltd.
K183035 11/01/2018 Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle Cook Incorporated
K183051 11/02/2018 Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set Cook Incorporated
K203573 12/07/2020 RESPONSE Navigation Instruments OrthoPediatrics, Corp.
K223786 12/19/2022 Orthex External Fixation System OrthoPediatrics Corp.
K210908 03/29/2021 Surgical Mask Sichuan Prius Biotechnology Co., Ltd.
K221066 04/12/2022 Sterile Hypodermic Needles for Single Use Sichuan Prius Biotechnology Co., Ltd.
K221068 04/12/2022 Sterile Hypodermic Syringes for Single Use with Needles Sichuan Prius Biotechnology Co., Ltd.
K221069 04/12/2022 Infusion Sets for Single Use with Needles Sichuan Prius Biotechnology Co., Ltd.
K221073 04/12/2022 Sterile Hypodermic Syringes for Single Use with Safety Needles Sichuan Prius Biotechnology Co., Ltd.
K221075 04/12/2022 Infusion Sets for Single Use Sichuan Prius Biotechnology Co., Ltd.
K221078 04/12/2022 Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use Sichuan Prius Biotechnology Co., Ltd.
K221079 04/12/2022 Sterile Hypodermic Syringes for Single Use Sichuan Prius Biotechnology Co., Ltd.
K221080 04/12/2022 Sterile Safety Hypodermic Needles for Single Use Sichuan Prius Biotechnology Co., Ltd.
K141390 05/27/2014 INTERMITTENT PNEUMATIC COMPRESSION DEVICE WUHAN LANDING MEDICAL HI-TECH LTD
K223709 12/12/2022 Kyphoplasty Balloon Catheter Jiangsu Changmei Medtech Co., Ltd.
K203410 11/19/2020 ENFit Disposable Enteral Syringe Shantou Wealy Medical Instrument Co., Ltd.
K203613 12/10/2020 ENFit Reusable Enteral Syringe Shantou Wealy Medical Instrument Co., Ltd.
K201324 05/18/2020 Antibacterial Bandage Jiangsu Excellence Medical Supplies Co., Ltd
K181659 06/25/2018 Avologi ENEO Premier North America Inc.
K161938 07/14/2016 Fingertip Pulse Oximeter XUZHOU YONGKANG ELECTRONIC SCIENCE TECHNOLOGY CO., LTD
K162616 09/20/2016 Wrist Type Blood Pressure Monitor Xuzhou Yongkang Electronic Science Technology Co., Ltd


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