914 results · 44ms · Sources: EU EUDAMED, US FDA

AST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

XPAND BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 20587, 20588, 20589, 20603, 20604, 20605

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

ABBOTT HSV EIA

FDA 510(k)
FDA Class 2 ·Microbiology

VISION -FORMERLY PDA- ALKALINE PHOSPHATASE

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

CREATININE

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

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

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