5,905 results · 41ms · 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

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit

FDA 510(k)
FDA Class 2 ·Neurology

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