4,832 results · 47ms · Sources: EU EUDAMED, US FDA

GEM Premier 3500

FDA registration
Instrumentation Laboratory Co.·7 products·🇺🇸 United States

GEM Premier 3500

FDA registration
INSTRUMENTATION LABORATORY CO. - Devens·7 products·🇺🇸 United States

GEM Premier 3500

FDA registration
INSTRUMENTATION LABORATORY CO.·7 products·🇺🇸 United States

Anaplasma Spp. And Ehrlichia Spp. Serological Reagents

FDA classification
FDA Not Classified ·Anaplasma Spp. And Ehrlichia Spp. Serological Reagents

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval
FDA Class 3 ·Nucleus® Hybrid™ L24 Cochlear Implant System

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·Nucleus® 22 Cochlear Implant System

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·Nucleus® 22 Cochlear Implant System

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·Nucleus® 24 Cochlear Implant System

Implant, Auditory Brainstem

FDA Pre-Market Approval
FDA Class 3 ·Nucleus® 24 Auditory Brainstem Implant System

PUFFClicker3 Inhaler Dose Counter & PUFFClicker3 Companion App

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Aseptika Limited·1 device

Sensor, Glucose, Invasive, Non-Adjunctive

FDA Pre-Market Approval
FDA Class 3 ·DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

Leishmania Spp. Antigen Detection Assay

FDA classification
FDA Class 1 ·Leishmania Spp. Antigen Detection Assay

ECG247 APP to be used with ECG247 Smart Sensor

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Appsens AS·1 device

High Sensitivity C-reactive Protein Kit(Particle-enhanced Immunoturbidimetric Assay Method)、HS-CRP Calibrator

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·7 devices

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval
FDA Class 3 ·AMS 700 INFLATABLE PENILE PROSTHESIS

Free Radical Assay, Methadone

FDA classification
FDA Class 2 ·Free Radical Assay, Methadone

Splint, Nasal

FDA classification
FDA Class 1 ·Splint, Nasal

Babesia Spp. Serological Reagents

FDA classification
FDA Not Classified ·Babesia Spp. Serological Reagents

Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens

FDA classification
FDA Class 2 ·Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens

Bartonella Spp. Serological Reagents

FDA classification
FDA Not Classified ·Bartonella Spp. Serological Reagents