305 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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TERRA FEMME
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MICRODOT & MICRODOT XTRA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VIEWING CLIENT MOBILE
FDA 510(k)
FDA Class 2
·Radiology
GEEN MEDISOX
FDA 510(k)
FDA Class 2
·General Hospital
MICRODOT BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ZAP HCG TEST, MODEL 8001
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MICRODOT XTRA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·SPRINTER OVER THE WIRE (OTW) & SPRINTER MULTI-EXCHANGE (MX2) BALLOON DILATATION CATHETER
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATATION CATHETER (NC STORMER OTW & NC STORMER MX2)
23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
FDA 510(k)
FDA Class 2
·Medical Genetics
Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems
FDA 510(k)
FDA Class 2
·Medical Genetics
Quantidex qPCR BCR-ABL IS Kit
FDA 510(k)
FDA Class 2
·Medical Genetics
ipsogen JAK2 RGQ PCR Kit
FDA 510(k)
FDA Class 2
·Medical Genetics
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
FDA 510(k)
FDA Class 2
·Medical Genetics
QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System
FDA 510(k)
FDA Class 2
·Medical Genetics
ipsogen JAK2 RGQ PCR Kit
FDA 510(k)
FDA Class 2
·Medical Genetics
MUTYH-Associated Polyposis (MAP)
FDA 510(k)
FDA Class 2
·Medical Genetics
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
FDA 510(k)
FDA Class 2
·Medical Genetics
Helix Laboratory Platform
FDA 510(k)
FDA Class 2
·Medical Genetics
BCR-ABL1 (p210) % IS Kit (Digital PCR Method)
FDA 510(k)
FDA Class 2
·Medical Genetics