510(k) Device Clearances

ResolutionMD

ResolutionMD, Inc.

LungPoint Virtual Bronchoscopic Navigation (VBN) Software

Broncus Medical, Inc.

Pulse Oximeter

Shenzhen Mericonn Technology Co., Ltd.

Rapid CTA 360

Ischemaview

Langston dual lumen catheter

Vascular Solutions, LLC

Rejoyn

Otsuka America Pharmaceutical, Inc.

Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use With Chemotherapy Drugs and Fentanyl Citrate

Luliang Hongruida Health Protection Technology Co., Ltd.

cmAngio® V1.0

Curemetrix, Inc.

aprevo® cervical interbody system

Carlsmed, Inc.

ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)

Biomerieux S.A.

OSSIOfiber® Suture Anchor

OSSIO , Ltd.

Anovo Surgical System (6Ne)

Momentis Surgical , Ltd.

Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs

Mah Sing Healthcare Sdn. Bhd.

Denture Base

Shandong Huge Dental Material Corporation

Xpert® SA Nasal Complete

Cepheid®

LC ChromeFlow

S&C Polymer Silicon- Und Composite Spezialitaten GmbH

CoreLink Navigation Instruments

Corelink, LLC

Arthrex FiberTak Suture Anchor

Arthrex, Inc.

Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (3

Nuwellis, Inc.

IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)

Shenzhen Huaruibo Electric Appliances Co., Ltd.

Wrap Accessory Electrodes

Hi-Dow International, Inc.

HandPICO Fractional Laser Handpiece Tip

Vydence Medical

esolution® Esophageal Retractor

S4 Medical Corp.

EPIQ Series Diagnostic Ultrasound System

Philips Ultrasound, LLC

Combi Touch

Mectron S.P.A.

Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601

Neuralynx, Inc.

Orthoscan VERSA Mini C-Arm

Ziehm-Orthoscan, Inc.

DEKA ACE Pump System

Deka Research and Development

Power Wheelchair (OS-R-M01I)

Beijing OrionStar Technology Co., Ltd.

Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist

Convatec