1,008 results · 20ms · Sources: EU EUDAMED, US FDA

MEDCOMP ASH SPLIT

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

RAPID IMMUNO-ASSAY SYS

FDA 510(k)
FDA Class 2 ·Hematology

GENERAL DIAGNOSTICS PLATELET ANTIBODY

FDA 510(k)
FDA Class 2 ·Hematology

REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS

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

MEDCOMP REPAIR KIT, MODEL ASPCRPK

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

BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT)

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)

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

EasySep™ Human Bone Marrow CD138 Positive Selection Kit (100-0748)

FDA 510(k)
FDA Class 2 ·Immunology

RETRO REPAIR KIT, MODEL PRRK5

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

CPR C-SECTION DELIVERY PACK

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

C-SECTION TRAY

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

LABOR AND DELIVERY TRAY

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

QAB2A IGM ELISA KIT

FDA 510(k)
FDA Class 2 ·Immunology

CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000

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

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

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·THE NORMALINE KIT

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·THE NORMALINE KIT

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·Abbott RealTime CMV Amplification Kit (09N21-090), Abbott RealTime CMV Control Kit (09N21-080), Abbott RealTime CMV Cali

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·Abbott RealTime HCV GT II