4,176 results · 79ms · Sources: EU EUDAMED, US FDA

AXSYM CYCLOSPORINE

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

FOX PLUS PTA CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT

FDA 510(k)
FDA Class 2 ·General Hospital

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)

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

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV

Alkaline Phosphatase

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Alinity i STAT High Sensitivity Troponin-I

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES)

FDA 510(k)
FDA Class 2 ·Cardiovascular

ARCHITECT STAT High Sensitivity Troponin-I

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Alinity i STAT High Sensitivity Troponin-I

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Abbott Diagnostics GmbH

Importer
🇩🇪 Germany·6 Manufacturers

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT REALTIME HBV ASSAY

Abbott GmbH

Authorized representative
🇩🇪 Germany·4 Manufacturers

MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

FLEXIFLO ENTERAL FEEDING TUBE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

AMBULATORY ENTERAL NUTRITION PUMP

FDA 510(k)
FDA Class 2 ·General Hospital

ROSS EMBRACE ENTERAL PUMP

FDA 510(k)
FDA Class 2 ·General Hospital

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT REALTIME CMV

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

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT CORE (LN 6L22)

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

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS