2,157 results · 38ms · Sources: EU EUDAMED, US FDA

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·VITROS Immunodiagnostic Products HBsAg Reagent Pack, Calibrator and Confirmatory Kit

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·VITROS Immunodiagnostic Products HBsAg Reagent Pack, Calibrator and Confirmatory Kit

NPi-300 Pupilometer System

Basic UDI-DI
EU MDD · Eu Md Class 1 ·NeurOptics, Inc.·1 device

ACROSIS COVID-19 Ag (NPS)

Basic UDI-DI
EU IVDD · Eu Ivd General ·SG Medical Inc.·1 device

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

MEDIN TECH ZIRCONIA-CP10, SS1000

FDA 510(k)
FDA Class 2 ·Dental

The Anika Complex for Musculoskeletal System Rehabilitation with Biofeedback

Basic UDI-DI
EU MDR · Eu Md Class 1 ·OOO NPF "Rehabilitation technologies"·1 device

Alkaline Phosphatase Kit (Kinetic Method with NPP-AMP)

Basic UDI-DI
EU IVDD · Eu Ivd General ·MedicalSystem Biotechnology Co., Ltd.·1 device

Clarity®

FDA UDI
Elekta Ltd·07540180000207·Clarity® Software

Clarity®

FDA UDI
Elekta Solutions AB·07540180000023·Clarity® Acquisition Station (310C00)

Clarity®

FDA UDI
Elekta Solutions AB·07540180000016·Clarity® System 310C00

Clarity®

FDA UDI
Elekta Solutions AB·07540180000146·Clarity® CPI, Railed

Clarity®

FDA UDI
Elekta Ltd·07540180000184·Clarity® Software

Clarity®

FDA UDI
Elekta Solutions AB·07540180000177·Clarity® QA Phantom

Clarity®

FDA UDI
Elekta Solutions AB·07540180000061·Clarity® Linear Probe (L14-5W/60)