510(k) Device Clearances

Agile Devices Angler Steerable, Deflectable Microcatheter

Agile Devices, Inc.

Mobility Scooter (W3465, W3902 (S50 Carbon))

Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

ClearSafe Closed System

MedSource Labs, LLC

Bolo Button System

Fusion Orthopedics

FROG (Filter Removal of Glass)

Carrtech Corp

Bone Screw

Osstem Implant Co., Ltd.

Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx

Healstone Biotech, Inc.

Sontro® OTC Hearing Aids (AI)

Soundwave Hearing, LLC

Spark™ Clear Aligner System

Ormco Corporation

Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor

Suzhou Endophix Co., Ltd.

BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL

NIKKISO CO., LTD.

Freedom Infinia™ Total Knee System

Maxx Orthopedics, Inc.

LEGION Total Knee System

Smith & Nephew, Inc.

Prelude Wave Hydrophilic Sheath Introducer

Merit Medical Systems, Inc.

Avenir® Müller Stem; Avenir Complete™ Hip System

Zimmer, Inc.

ENFit to ENFit Extension Sets

Vesco Medical

Conformity Stem Extension Line, #0

United Orthopedic Corporation

Rejoni Intrauterine Catheter

Rejoni, Inc.

Diode Laser Hair Removal Device

Guangzhou Chuang Zao Mei Technology Co., Ltd.

Ion Facet Screw System

SurGenTec, LLC

FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing

Koru Medical Systems, Inc.

DT Controlled Phototherapy Equipment

Daavlin Distributing Co.

Genesys Spine 3DP Lumbar Interbody System

Genesys Spine

Wearable breast pump (model W8)

Shenzhen TPH Technology Co., Ltd.

Philips IntelliSite Pathology Solution 5.1

Philips Medical Systems Nederland B.V.

VERVE

Oculomotor Technologies

Archer PSI System

3D-Side

Kiba CTO Crossing Catheter

Reflow Medical, Inc.

TE Air Diagnostic Ultrasound System

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

STOPWET iontophoresis apparatus (SW01)

Taiwan Medical Electronics Co., Ltd.