21 results · 44ms · Sources: EU EUDAMED, US FDA

VIVACHEK BIOTECH (HANGZHOU) CO., LTD

FDA registration
VIVACHEK BIOTECH (HANGZHOU) CO., LTD·1 product·🇨🇳 China

VivaChek Blood Glucose and B-Ketone Monitoring System

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Nitroprusside, Ketones (Urinary, Non-Quant.)

FDA classification
FDA Class 1 ·Nitroprusside, Ketones (Urinary, Non-Quant.)

AccuQuest

FDA UDI
Bernafon AG·05711584088135·AQ CO3 B 105, 2.4G NFM DPB SABE/MSIL DEMO ACCUQ

Hi-Torque Powerturn Guide Wires

FDA registration
ABBOTT VASCULAR·1 product·🇺🇸 United States

ROMD, LLC

FDA registration
ROMD, LLC·1 product·🇺🇸 United States

EVOL Lumbar Interbody System

FDA registration
CUTTING EDGE SPINE·1 product·🇺🇸 United States

wire, guide, catheter HT POWERTURN Guide Wires (includes POWERTURN ULTRA and FLEX)

FDA registration
Sterigenics Radiation Technologies, LLC·1 product·🇺🇸 United States

Hi-Torque Powerturn Guide Wires

FDA registration
Abbott Vascular Netherlands·1 product·🇳🇱 Netherlands

Hi-Torque Powerturn Guide Wires

FDA registration
ABBOTT VASCULAR·1 product·🇺🇸 United States

Heli-FX EndoAnchor System

FDA registration
Medtronic Distribution Center·1 product·🇺🇸 United States

SB-KAWASUMI LABORATORIES, INC.

FDA registration
SB-KAWASUMI LABORATORIES, INC.·3 products·🇯🇵 Japan

KAWASUMI LABORATORIES (THAILAND) CO., LTD.

FDA registration
KAWASUMI LABORATORIES (THAILAND) CO., LTD.·3 products·🇹🇭 Thailand

Heli-FX EndoAnchor System

FDA registration
MEDTRONIC PERFUSION SYSTEMS·1 product·🇺🇸 United States

Synergy Health Ireland Ltd

FDA registration
Synergy Health Ireland Ltd·1 product·🇮🇪 Ireland

BD MAX Vaginal Panel

FDA registration
BECTON, DICKINSON & CO.·1 product·🇺🇸 United States

KAWASUMI LABORATORIES AMERICA, INC.

FDA registration
KAWASUMI LABORATORIES AMERICA, INC.·3 products·🇺🇸 United States

CUTTING EDGE SPINE INTERBODY FUSION DEVICE

FDA 510(k)
FDA Class 2 ·Orthopedic

VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST

FDA 510(k)
FDA Class 2 ·Microbiology

Respiratory Virus Panel Nucleic Acid Assay System

FDA classification
FDA Class 2 ·Respiratory Virus Panel Nucleic Acid Assay System