17 results · 42ms · Sources: EU EUDAMED, US FDA

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

ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

Gabapentin Assay

FDA classification
FDA Class 2 ·Gabapentin Assay

Oticon

FDA UDI
Oticon A/S·05707131165343·K140, ITE VC AP WL R BE

CD HORIZONSpinal System

FDA registration
MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO·5 products·🇺🇸 United States

CD HORIZONSpinal System

FDA registration
MEDTRONIC SOFAMOR DANEK USA, INC.·5 products·🇺🇸 United States

Medizin Produkte Neustadt GmbH (MPN)

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

CD HORIZONSpinal System

FDA registration
Medtronic Medical Costa Rica S.R.L.·5 products·🇨🇷 Costa Rica

CD HORIZONSpinal System

FDA registration
WARSAW ORTHOPEDIC, INC.·5 products·🇺🇸 United States

CD HORIZONSpinal System

FDA registration
Medtronic Engineering and Innovation Center (MEIC)·5 products·🇮🇳 India

OQW / 2009 h1n1 influenza virus (swine origin), nucleic acid or antigen, detection and identification

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

CEDIA Opiate OFT Assay

FDA registration
Microgenics Corporation·1 product·🇺🇸 United States

DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600

FDA 510(k)
FDA Class 2 ·Immunology

UNIPLANT DENTAL IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

System, Test, Anticardiolipin Immunological

FDA classification
FDA Class 2 ·System, Test, Anticardiolipin Immunological

Implant, Endosseous, Root-Form

FDA classification
FDA Class 2 ·Implant, Endosseous, Root-Form