147 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
×
INNOFLOUR TOPIRAMATE REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Toxicology
INNOFLOUR CALIBRATOR REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Toxicology
IMX HOMOCYSTEINE
FDA 510(k)
FDA Class 2
·Immunology
INNOFLUOR QUINIDINE ASSAY SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MODIFICATION TO IMX HOMOCYSTEINE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INNOFLUOR PHENOBARBITAL ASSAY SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
INNOFLUOR PHENYTOIN ASSAY SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
INNOFLUOR GENTAMICIN ASSAY SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FDA Pre-Market Approval
FDA Class 2
·ACCESS HYBRITECH PSA REAGENTS ACCESS IMMUNOASSAY SYSTEMS
ACTOnco, ACTOnco IVD
FDA 510(k)
FDA Class 2
·Pathology
TD-7301 Spirometer (TD-7301)
FDA 510(k)
FDA Class 2
·Anesthesiology
TD-7301 Peak Flow meter
FDA 510(k)
FDA Class 2
·Anesthesiology
TD-5010 Lancing Device and TD-5084 Sterile Lancets
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NTU-USB Ultrasound USB Box
FDA 510(k)
FDA Class 2
·Radiology
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FDA Pre-Market Approval
FDA Class 2
·ACCESS HYBRITECH PSA ON THE SYNCHRON LXI 725 SYSTEM
Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Single Use Arthroscopic Electrode (with Pencil)
FDA 510(k)
FDA Class 2
·Orthopedic
LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery