510(k) Device Clearances

TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)

Jiangxi Royall Smart Technology Co., Ltd.

Orthex External Fixation System

OrthoPediatrics Corp.

3N Contact Lenses Adjunct Cleaner

Suzhou 3N Biological Technology Co., Ltd.

Surgical Mask

Remade USA, LLC

BENCOX Mirabo Z Cup Cortinium

Corentec Co., Ltd.

Legend X Platform

Pollogen, Ltd.

Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 1

Potrero Medical, Inc.

MIM – Symphony HDR Fusion

Mim Software, Inc.

Mpres Neck Preserving Stem

Medacta International S.A.

Axon Therapy

Neuralace Medical, Inc.

AMSafe NeuFlo Needleless Connector

Amsino International, Inc.

Eargo 5 , Eargo 6

Eargo, Inc.

Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG

Shenzhen Ulike Smart Electronics Co., Ltd.

Sterile Auto-Disable Syringes with/without Needle for Single Use

Zhejiang Kangkang Medical-Devices Co., Ltd.

Arthrex NanoScope System

Arthrex, Inc.

SpO2 Extension Cable

Beijing Rongrui-Century Science & Technology Co., Ltd.

Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer

Biocomposites, Ltd.

Dream Medi Sterile Surgical Gown (SurgicalGownUL)

Dae Myung Chemical Co., Ltd. (Vietnam)

Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars)

Jiangsu Channel Medical Device Co., Ltd.

93 NeuFlex Catheter

Piraeus Medical

CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument

Sebia

Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant

Promimic AB

Disposable Surgical Gown

Henan Robestain Medical Products Co., Ltd.

Knee+

Pixee Medical

4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)

Shenzhen Sophway Technology Co., Ltd.

myray ProXIma X6

Cefla S.C.

Treace Medical Systems (TMC) Plating System

Treace Medical Concepts, Inc.

RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles

Myco Medical Supplies, Inc.

Disposable Nitrile Medical Examination Glove

Siyang Threeguard Medical Supplies Co., Ltd.

Alio Medical Remote Monitoring System

Graftworx, Inc. Dba Alio