510(k) Device Clearances

SENDERO Microcatheter

Okami Medical, Inc.

MIKRON TRAUMA BONE PLATE& SCREW SYSTEM

Mikron Makina San. ve Tic. Ltd. Sti.

Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2); Single use flexible ureteroscope (UR

Shenzhen Besdata Technology Co., Ltd.

Xpert® Xpress CoV-2 plus (XPRS-COV2-10)

Cepheid®

AccelFix Spinal Fixation System

L&K BIOMED Co., Ltd.

BD MAX Enteric Parasite Panel

Becton, Dickinson and Company

RadianceTx Radionuclide Brachytherapy Source

Radiance Therapeutics, Inc.

RadiForce RX270

Eizo Corporation

Ruthless Spine RJB

Ruthless, LLC Dba Ruthless Spine

Pulse Oximeter

Dongguan Lingxin Technologies Co., Ltd.

Led Mask Platinum Md

Cellreturn Co., Ltd.

Minder System

Epi-Minder Pty, Ltd.

CurvaFix IM System

Curvafix, Inc.

TightRail Guardian Motorized Dilator Sheath

Spectranetics, Inc.

handLITE (TN19S)

iSMART Developments, Ltd.

Connected OR Hub with Device and Voice Control

Stryker Corporation

White Nitrile Powder Free Patient Examination Glove, Non Sterile

Safeskin Retailing (Hk) Limited

FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit

ZuriMED Technologies AG

VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup

Advin Biotech, Inc.

Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)

Hartalega NGC Sdn. Bhd.

LipoSurg ARTIST

NOUVAG AG

BTL-398

BTL Industries, Inc.

uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis

Shanghai United Imaging Healthcare Co., Ltd.

Medline Level 4 Surgical Gown with Breathable Sleeves

Medline Industries, LP

POINT Kinguide Agile Robotic Arm Surgical Stereotactic System

Point Robotics MedTech, Inc.

VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-

bioMerieux, Inc.

Disposable ureteral stent

Shenzhen Trious Medical Technology Co., Ltd.

iTEAR100 Neurostimulator

Olympic Ophthalmics

Disposable Medical Mask

Jiangsu Nanfang Medical Co., Ltd.

SINEFIX

BAAT Medical Products B.V.