Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics SNM System

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

VCONE

Device

EU MDR · Eu Md Class 2a ·Kims Med Co., Ltd.·Not intended for eu market

Motiva Insertion Sleeve

Device

EU MDR · Eu Md Class 2a ·Kims Med Co., Ltd.·On the market·5 countries

HydroCone

Device

EU MDR · Eu Md Class 2a ·Kims Med Co., Ltd.·On the market·2 countries

EZ Fan

Device

EU MDR · Eu Md Class 2a ·Kims Med Co., Ltd.·On the market·11 countries

KNH Disposable Medical Face Mask - Type II

Device

EU MDR · Eu Md Class 1 ·KNH Enterprise Co., Ltd.·On the market·32 countries

KNH Disposable Medical Face Mask - Type IIR

Device

EU MDR · Eu Md Class 1 ·KNH Enterprise Co., Ltd.·On the market·32 countries

Ranir Changshu Oral Care CO., Ltd

FDA registration

Ranir Changshu Oral Care CO., Ltd·1 product·🇨🇳 China

PRIMED MEDICAL PRODUCTS INC.

FDA registration

PRIMED MEDICAL PRODUCTS INC.·1 product·🇨🇦 Canada

Claris System

FDA registration

Choice Spine·2 products·🇺🇸 United States

Ranir Changshu Oral Care CO., Ltd

FDA registration

Ranir Changshu Oral Care CO., Ltd·1 product·🇨🇳 China

Ranir Changshu Oral Care CO., Ltd

FDA registration

Ranir Changshu Oral Care CO., Ltd·1 product·🇨🇳 China

ORIA Spinal Clip System (SCS)

FDA registration

Choice Spine·3 products·🇺🇸 United States

VEO Lateral Access & Interbody Fusion Sy stem

FDA registration

Choice Spine·1 product·🇺🇸 United States

Harrier-SA Lumbar Interbody System

FDA registration

Choice Spine·1 product·🇺🇸 United States

Raven Lumbar Plate System

FDA registration

Choice Spine·1 product·🇺🇸 United States

Typhoon Choice Spine Vertebral Body Replacement (VBR) System

FDA registration

Choice Spine·1 product·🇺🇸 United States

Thunderbolt and Lancer Pedicle Screw System

FDA registration

Choice Spine·3 products·🇺🇸 United States

Silverbolt/Mainframe

FDA registration

Choice Spine·3 products·🇺🇸 United States