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

Easy@Home Pregnancy Test (EZW1-S, EZW1-M)

FDA registration
EASY HEALTHCARE CORPORATION·1 product·🇺🇸 United States

HEALGEN SCIENTIFIC LLC

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

Clinical Guard

FDA registration
Mandarin Enterprises, LLC·1 product·🇺🇸 United States

Pregnancy One Step Rapid Test (Midstream)

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

PREGNANCY ONE STEP RAPID TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

OTF / Gabapentin assay DLJ / Calibrators, drug specific LAS / Drug specific control materials

FDA registration
MONOCENT INC.·3 products·🇺🇸 United States

ARK Gabapentin Assay

FDA registration
ARK DIAGNOSTICS INC·3 products·🇺🇸 United States

Medizin Produkte Neustadt GmbH (MPN)

FDA registration
Medizin Produkte Neustadt GmbH (MPN)·1 product·🇩🇪 Germany

Kit, Test, Pregnancy, Hcg, Over The Counter

FDA classification
FDA Class 2 ·Kit, Test, Pregnancy, Hcg, Over The Counter

SUPERIOR-LOC HIP SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304237131·

RINGLOC HIP SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304229754·

RINGLOC HIP SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304198579·

Voyager with Optional PulseOx Transport Incubator

FDA registration
INTERNATIONAL BIOMEDICAL, LTD.·1 product·🇺🇸 United States

ACCENT

FDA 510(k)
FDA Class 2 ·Radiology

COLLEXA

FDA 510(k)
FDA Unclassified ·Unknown

Wound Dressing With Animal-Derived Material(S)

FDA classification
FDA Unclassified ·Wound Dressing With Animal-Derived Material(S)

System, Image Processing, Radiological

FDA classification
FDA Class 2 ·System, Image Processing, Radiological