Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·PRESTIGE® Cervical Disc

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·RESOLUTION ctDx FIRST

Bone Sonometer

FDA classification

FDA Class 2 ·Bone Sonometer

Maggots, Medical

FDA classification

FDA Unclassified ·Maggots, Medical

Mask, Surgical, Eua Authorized

FDA classification

FDA Not Classified ·Mask, Surgical, Eua Authorized

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS, ADVIA CENTAUR HBC TOTAL QUALITY CONTROL

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·ORTHOPAK II BONE GROWTH STIMULATOR

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne Liquid CDx (F1 Liquid CDx)

Amstermed B.V.

Authorized representative

🇳🇱 Netherlands·50 Manufacturers·272 Devices

Hofmeester Dental B.V.

Importer

🇳🇱 Netherlands·16 Manufacturers

Leeches, Medicinal

FDA classification

FDA Unclassified ·Leeches, Medicinal

Adult Portable Bed Rails For Medical Purposes

FDA classification

FDA Class 1 ·Adult Portable Bed Rails For Medical Purposes

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·Guardant360 CDx

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne Liquid CDx (F1 Liquid CDx)

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne Liquid CDx

Barrier Face Covering Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy

FDA classification

FDA Not Classified ·Barrier Face Covering Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy

Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua

FDA classification

FDA Not Classified ·Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS

COBAS INTEGRA REAGENT CASSETTES

FDA registration

ROCHE DIAGNOSTICS GMBH·27 products·🇩🇪 Germany

American Dental Systems GmbH

Importer

🇩🇪 Germany·37 Manufacturers