510(k) Device Clearances

NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)

ICU Medical

Esophageal TTS Stent

Taewoong Medical

Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs)

Xingyu Medical Tech Co., Ltd.

Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange an

Encompass Industries Sdn. Bhd.

Waterlase iPLus

Biolase, Inc.

HD60 Series Ultrasound Diagnostic System

Qingdao Hisense Medical Equipment Co., Ltd.

Phantom XL Insulated Dilators

TeDan Surgical Innovations, Inc.

HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)

Hilltek, LLC

Syngo Carbon Clinicals (VA41)

Siemens Healthineers AG

Inogen Rove 4 Portable Oxygen Concentrator

Inogen

Aevumed PROTEKT Suture Anchor

Aevumed, Inc.

Arm-type Fully Automatic Digital Blood Pressure Monitor

Joytech Healthcare Co. , Ltd.

SIGNEX

Osteonic Co., Ltd.

FX Contra

Nakanishi, Inc.

Hive™ Standalone Cervical System

NanoHive Medical, LLC

Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G

Owen Mumford, Ltd.

Tandry Compression Screw System

Microware Precision Co., Ltd.

BlueCheck™ Caries Detection & Monitoring

Incisive Technologies Pty, Ltd.

DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)

DiaDent Group International

Plus Medical Cover Gown

Foshan Nanhai Plus Medical Co, Ltd.

NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellan

Hycor Biomedical

Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)

Canon Medical Systems Corporation

ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring

Longeviti Neuro Solutions

BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes

Becton, Dickinson and Company

YUWELL Finger Pulse Oximeter

Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.

Bard Access Systems, Inc.

InMode Multi-system

InMode , Ltd.

iRoot SP Plus

Innovative Bioceramix, Inc.

RFG-01

Zimmer Medizinsysteme GmbH

RIGEL™ 3DR Anterior Cervical Corpectomy System

MiRus, LLC