510(k) Device Clearances

Intermittent Catheter (Not Finalized)

Hollister Incorporated

Electric Wheelchair, Model: 9000N

Silver Fox Corporation Limited

CeraRoot TL Implant System (TL)

Ceraroot SL

TiLink-L™ SI Joint Fusion System

SurGenTec, LLC

IdentiTi ALIF Interbody Systems

Alphatec Spine, Inc.

V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System

Samsung Medison Co., Ltd.

GECHO

Narnar, LLC

IH Implant System

Sewonmedix, Inc.

MBT Compass HT CA Software; MBT FAST Shuttle US IVD

Bruker Daltonics GmbH & Co. KG

XACT ACE Robotic System

Xact Robotics, Ltd.

Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)

Guangzhou Red Pine Medical Instrument Co., Ltd.

YY-A02-B Overlapped Compression Therapy

Huizhou Xinyi Technology Co., Ltd.

DIASAFEplusUS (F00013010)

Fresenius Medical Care Renal Therapies Group, LLC

Multi M Series

Dmax Co., Ltd.

Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO)

Liaoning Rachcera Material Technology Co., Ltd.

SmartGuard Technology; Predictive Low Glucose Technology

Medtronic MiniMed

Momcozy Wearable Breast Pump (BP311); Momcozy Wearable Breast Pump (BP223); Momcozy Wearable Breast Pump (BP324); Momcoz

Shenzhen Root Innovation Technology Co., , Ltd.

PathBuilder Steerable Introducer

Shanghai Microport EP Medtech Co., Ltd.

KabiHelp® Uno; KabiHelp® Advance plus

Fresenius Kabi AG

Magnifico Open (100009900)

Esaote, S.p.A.

Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors

Responsive Arthroscopy, LLC

NorthStar Mapping System (MAP01 or MAP01-01)

Imricor Medical Systems, Inc.

VASSALLO GT EXT

Filmecc Co., Ltd.

PuraStat GI

3-D Matrix, Inc.

Titan Dental Design

Clearadvance, LLC

Access TPO Antibody

Beckman Coulter, Inc.

Vscan Air

GE Medical Systems Ultrasound and Primary Care Diagnostics

Tyto Insights for Rhonchi Detection

Tyto Care , Ltd.

Access Thyroglobulin

Beckman Coulter, Inc.

ANKYRAS

Mentice Spain S.L.