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

SMARTCYCLER DX SYSTEM AND SOFTWARE

FDA registration
CEPHEID·1 product·🇺🇸 United States

SMARTCYCLER DX SYSTEM AND SOFTWARE

FDA registration
Cepheid·1 product·🇺🇸 United States

SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B

FDA 510(k)
FDA Class 1 ·Microbiology

Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

FDA classification
FDA Class 1 ·Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

Dura Derm Sport

FDA registration
BRISAR INDUSTRIES INC·1 product·🇺🇸 United States

DURADERM SPORT

FDA registration
APERTUS PHARMACEUTICALS, LLC·1 product·🇺🇸 United States

DuraDerm Sport; Preventogen

FDA registration
J. PENNER CORPORATION·1 product·🇺🇸 United States

BEIJING WANDONG MEDICAL TECHNOLOGY CO.,LTD

FDA registration
MRI DIVISION, Beijing Wandong Medical Technology Co.,Ltd·1 product·🇨🇳 China

PREVENTOGEN

FDA registration
E-BEAM SERVICES, INC.·1 product·🇺🇸 United States

Preventogen

FDA registration
PREVENT PLUS, LLC.·1 product·🇺🇸 United States

Orthopro Hemi Toe

FDA registration
WRIGHT MEDICAL TECHNOLOGY, INC.·1 product·🇺🇸 United States

PROBE, RADIOFREQUENCY LESION

FDA registration
TOP CORPORATION·1 product·🇯🇵 Japan

MODIFICATION TO VAXCEL DIALYSIS CATHETER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT

FDA 510(k)
FDA Class 2 ·Hematology

Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

FDA classification
FDA Class 2 ·Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

Catheter, Hemodialysis, Implanted

FDA classification
FDA Class 2 ·Catheter, Hemodialysis, Implanted