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

ANTI-JO-1 MICROASSAY

FDA 510(k)

FDA Class 2 ·Immunology

VARELISA JO-1 ANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

ELISA-DOXA JO-1

FDA 510(k)

FDA Class 2 ·Immunology

SYNELISA JO-1 ANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

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

ATRICURE DISSECTOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BIPOLAR SNARE

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

VTI SUCTION IRRIGATION SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODEL TW SB, SCALP VEIN SET; MODEL TW LB, STERILE HYPODERMIC NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital