6,496 results · 49ms · Sources: EU EUDAMED, US FDA

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·LOTRAFILCON A & B SOFT CONTACT LENSES

COMEG MEDICAL TECHNOLOGIES

FDA UDI
SOPRO·03760278260045·A TURNKEY SOLUTION FOR CONSULTING ROOM DIAGNOST...

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

FDA Pre-Market Approval
FDA Class 3 ·ETI-MAK-2 PLUS ASSAY

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

FDA Pre-Market Approval
FDA Class 3 ·ETI-AB-AUK PLUS ASSAY

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

FDA Pre-Market Approval
FDA Class 3 ·ETI-AB-EBK PLUS ASSAY

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

FDA Pre-Market Approval
FDA Class 3 ·ETI-AB-COREK PLUS ASSAY

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval
FDA Class 3 ·G4 Insulin Pump with Dexcom G4 Platinum CGM System

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

FDA Pre-Market Approval
FDA Class 3 ·ETI-EBK-PLUS

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

FDA Pre-Market Approval
FDA Class 3 ·ETI-CORE-IGMK PLUS ASSAY

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval
FDA Class 2 ·SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Light Source, Fiberoptic, Routine

FDA classification
FDA Class 2 ·Light Source, Fiberoptic, Routine

Laryngoscope, Rigid

FDA classification
FDA Class 1 ·Laryngoscope, Rigid

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·IMMULITE Systems PSA, IMMULITE 2000 Systems PSA & IMMULITE Systems Third Generation PSA

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Genesis Neurostimulation System

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·ANIMAS VIBE SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·ADVIA Centaur HBsAgII (HBsII) and ADVIA Centaur HBsAgII Confirmatory (HBsII Conf) Assay

N/A

FDA UDI
SCHÖLLY FIBEROPTIC GmbH·04250480109045·NIR FI Light Source

Medicor International NV/SA

Importer
🇧🇪 Belgium·3 Manufacturers

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

FDA Pre-Market Approval
FDA Class 3 ·Atellica IM Hepatitis B e Antigen (HBeAg)

MICROFLOW-III IN SLEEVES W/SEP-COVER

FDA registration
Leica Biosystems Richmond, Inc.·1 product·🇺🇸 United States