10,000 results · 49ms · Sources: EU EUDAMED, US FDA

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Siello S 45/53/60, Solia S 45/53/60, Siello T 53/60, Siello JT 45/53, Solia T 53/60, Solia JT 45/53, EFH-6F-W

IMMY

FDA UDI
Immuno-Mycologics, Inc.·00816387020001·Aspergillus CF Antigen Dilute

IMMY

FDA UDI
Immuno-Mycologics, Inc.·00816387020599·Histoplasma Mycelial CF Antigen

IMMY

FDA UDI
Immuno-Mycologics, Inc.·00816387020582·Coccidioides CF Antigen

IMMY

FDA UDI
Immuno-Mycologics, Inc.·00816387020605·Histoplasma Yeast CF Antigen

U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

TD-1035 Thermometer

FDA 510(k)
FDA Class 2 ·General Hospital

URight Hemoglobin A1c system, FORA A1c System

FDA 510(k)
FDA Class 2 ·Hematology

ZEUS SCIENTIFIC

FDA registration
ZEUS SCIENTIFIC·1 product·🇺🇸 United States

BION Varicella-Zoster IFA; Substrate Slides

FDA registration
PHADIA US INC.·1 product·🇺🇸 United States

Diagnostic Hybrids D3 DFA Varicella

FDA registration
Ortho-Clinical Diagnostics, Inc.·1 product·🇺🇸 United States

VZV

FDA registration
Diagnostic Automation/ Cortez Diagnostics Inc,.·1 product·🇺🇸 United States

BION Varicella-Zoster IFA

FDA registration
BION ENTERPRISES, LTD.·1 product·🇺🇸 United States

Zostergent VZV Identification Reagent

FDA registration
VIRO RESEARCH LLC·1 product·🇺🇸 United States

QuickVue RSV 10

FDA registration
QUIDEL CORP.·1 product·🇺🇸 United States

CHORUS POLIOVIRUS IgG

FDA registration
DIESSE DIAGNOSTICA SENESE S.P.A·1 product·🇮🇹 Italy

ZHEJIANG ORIENT GENE BIOTECH

FDA registration
ZHEJIANG ORIENT GENE BIOTECH·1 product·🇨🇳 China

HEALGEN SCIENTIFIC LLC

FDA registration
HEALGEN SCIENTIFIC LLC·1 product·🇺🇸 United States

GQG / ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS

FDA registration
MONOCENT INC.·1 product·🇺🇸 United States

QuickVue Adenoviral conjunctivitis Test

FDA registration
QUIDEL CORP.·1 product·🇺🇸 United States