510(k) Device Clearances

SimPro™ Now, GentleCath™ Hydrophilic

Dentsply Sirona

Cholesterol2

Abbott Ireland Diagnostics Division

Ultrasound Transducer Cover

Vitrolife Sweden AB

Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic Ultrasound Sysem, Nuewa R9 Pro/ N

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Electrocardiograph, model: ECG301

Shenzhen LE Medical Technology Co., Ltd.

nordicMEDiVA

Nordicneurolab AS

Morpheus® Moldable; Agilon® Moldable

Biogennix, LLC

Neowise

Cefla S.C.

OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coro

Boston Scientific

Powder Free Nitrile Examination Gloves (Blue, Black, Indigo)

Ammex Corporation

Examination gloves-Type A(Latex gloves)

Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.

Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge

Chirurgie Innovation

Materialise TKA Guide System

Materialise NV

Surgical Face Mask

Megasoft (China) Co., Ltd.

CAC Software

Imbio, Inc.

Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)

Olympus Medical Systems Corporation

Mucosal Impedance Measurement System

Alandra Medical Sapi DE CV

DESS Dental Smart Solutions

Terrats Medical SL

NxStage PureFlow Solution

Nxstage Medical, Inc.

Virtual C DRF-NEO Digital Imaging System

Portavision Medical, LLC

HM70 EVO Diagnostic Ultrasound System

Samsung Medison Co., Ltd.

Collagen Wound Dressing

Winner Medical Co., Ltd.

Duet External Drainage and Monitoring System (EDMS)

Medtronic Neurosurgery

Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors

Shen Wei USA, Inc.

Dental Desensitizer

Guangzhou Beogene Biotech Co., Ltd.

Yushan X-Ray Flat Panel Detector with DROC

Innocare Optoelectronics Corp.

Vantage PSI System

3D Systems, Inc.

RODIN Palette Naturalizing Kit

Belport Company, Inc., Gingi-Pak

Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set

Route 92 Medical, Inc.

Sunny Plus (Sunny)

ShenB Co., Ltd.