SafePath

FDA registration

SAFEPATH MEDICAL, INC.·2 products·🇺🇸 United States

Solea

FDA registration

CONVERGENT DENTAL·1 product·🇺🇸 United States

Selectra Lead Introducer System

FDA registration

BIOTRONIK, INC.·1 product·🇺🇸 United States

Tai-shiny Nasal Aspirator (Non-Sterile)

FDA registration

TAI-SHINY TECHNOLOGY CO., LTD.·1 product·🇹🇼 Taiwan

Remote Assistant III

FDA registration

BIOTRONIK, INC.·1 product·🇺🇸 United States

BIOMONITOR IV

FDA registration

BIOTRONIK, INC.·1 product·🇺🇸 United States

Sharay Anti-Jo-1 IgG (CLIA)

Device

EU IVDD · Eu Ivd General ·C-Luminary Biotechnology Co., Ltd.·No longer on the market

Anti-Jo-1 IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Anti-Jo-1 IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

BioCLIA Autoimmune Calibrator Set, Jo-1

Device

EU IVDD · Eu Ivd General ·HOB Biotech Group Corp., Ltd.·On the market

BioCLIA Autoimmune Reagent Kit, Jo-1

Device

EU IVDD · Eu Ivd General ·HOB Biotech Group Corp., Ltd.·On the market

BioCLIA Autoimmune Control Set, Jo-1

Device

EU IVDD · Eu Ivd General ·HOB Biotech Group Corp., Ltd.·On the market

BioCLIA Autoimmune Reagent Kit, Jo-1

Device

EU IVDD · Eu Ivd General ·HOB Biotech Group Corp., Ltd.·On the market

Catheter, Percutaneous, Long Term, Intraspinal

FDA Pre-Market Approval

FDA Class 3 ·PORT-A-CATH EPIDURAL & PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS

iFlash-FT3

FDA registration

SHENZHEN YHLO BIOTECH CO., LTD.·1 product·🇨🇳 China

Methadone Urine Test ,Opiate Urine Test

FDA registration

GUANGZHOU WONDFO BIOTECH CO., LTD.·2 products·🇨🇳 China

Mask, surgical

FDA registration

CAREMAX CO., LTD.·1 product·🇨🇳 China

Methadone Urine Test (MTD 200)

FDA registration

GUANGZHOU WONDFO BIOTECH CO., LTD.·2 products·🇨🇳 China

EasyOne Air Spirometer

FDA registration

NDD MEDIZINTECHNIK AG·1 product·🇨🇭 Switzerland

EGENS Follicle Stimulating Hormone (FSH) Test Midstream

FDA registration

NANTONG EGENS BIOTECHNOLOGY CO.,LTD.·1 product·🇨🇳 China