Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLICOR HCV TEST

Fluid, Hysteroscopy

FDA Pre-Market Approval

FDA Class 3 ·DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM

SSW CARBIDE

FDA UDI

Ss White Burs, Inc.·D690100012·FG SL CARBIDE 4 - ROLL 100

SSW CARBIDE TRIMMING AND FINISHING

FDA UDI

Ss White Burs, Inc.·D6903500862·

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·VASCULAR SOLUTIONS DUETT SEALING DEVICE

Iodinated Contrast Media Transfer Tubing Set

FDA classification

FDA Class 2 ·Iodinated Contrast Media Transfer Tubing Set

Alfamed Medizinprodukte GmbH

Importer

🇦🇹 Austria·3 Manufacturers

a1 medical GmbH

Importer

🇩🇪 Germany·3 Manufacturers

ICON (LR) Limited

Authorized representative

🇮🇪 Ireland·37 Manufacturers·384 Devices

Bur, Ent, Diamond Coated, Single Use, Reprocessed

FDA classification

FDA Class 1 ·Bur, Ent, Diamond Coated, Single Use, Reprocessed

Synga medical b.v.

Importer

🇳🇱 Netherlands·10 Manufacturers

Polytech Domilens GmbH

Importer

🇩🇪 Germany·13 Manufacturers

Adhesive Backed Thermal Skin Patches

FDA classification

FDA Class 1 ·Adhesive Backed Thermal Skin Patches

W2O Medizintechnik AG

Importer

🇩🇪 Germany·14 Manufacturers

Vik Dental d.o.o.

Importer

🇭🇷 Croatia·11 Manufacturers

SIR OFTALMICA SRL

Importer

🇮🇹 Italy·16 Manufacturers

Line-Gold srl

Importer

🇧🇪 Belgium·21 Manufacturers

Polo MB Oisterwijk B.V.

Importer

🇳🇱 Netherlands·12 Manufacturers