4,469 results · 28ms · 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 ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATORS

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

FDA Pre-Market Approval
FDA Class 3 ·Alinity i Anti-HBs Reagent Kit (2x100 Tests), Alinity i Anti-HBs Reagent Kit (2x600 Tests), Alinity i Anti-HBs Reagent K

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

FDA Pre-Market Approval
FDA Class 3 ·Alinity i Anti-HBs Reagent Kit (2x 100 Tests), Alinity i Anti-HBs Reagent Kit (2x600 Tests), Alinity i Anti-HBs Reagent

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·DEEP BRAIN STIMULATION (DBS) EXTENSION KITS

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·INTERSTIM THERAPY SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·SYNCHROMED(TM) INFUSION SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Restore, ltrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Resume, Specify, and Vectris Spinal Cord Stimula

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·INTERSTIM THERAPY SYSTEM

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval
FDA Class 3 ·Vercise Deep Brain Stimulation (DBS) System and Vercise Gevia Deep Brain Stimulation (DBS) System

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, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATS

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

FDA Pre-Market Approval
FDA Class 3 ·VITROS IMMUNADIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATO

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Clinician Programmer Application Version 2.0.2, and Liberta RC DBS IPG Firmware Version 1.1.1

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Tripole, Tripole 16C, Tripole 16, Exclaim, Lamitrode 4, Lamitrode 44, Lamitrode S-4, Lamitrode S-8, Lamitrode 88, Lamitr

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval
FDA Class 3 ·Vercise PC and Vercise Gevia Deep Brain Stimulation (DBS) Systems

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Deep Brain Stimulation (DBS) System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Patient Controller Application Version 2.0.2

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

FDA Pre-Market Approval
FDA Class 3 ·ELECSYS ANTI-HBS TEST SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·ADVIA CENTAUR ANTI-HBS ASSAY

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·DEEP BRAIN STIMULATION (DBS) LEADS