19 results
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52ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 1
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ACON UTI URINARY TRACT INFECTION TEST STRIPS
FDA 510(k)
FDA Class 1
·Hematology
Mission Lipid Panel Monitoring System
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACON STREP A RAPID TEST DEVICE
FDA 510(k)
FDA Class 1
·Microbiology
Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System
FDA 510(k)
FDA Class 1
·Clinical Chemistry
QUIK-CHECK OVULATION PREDICTOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE
FDA 510(k)
FDA Class 1
·Microbiology
FSH MENOPAUSE PREDICTOR TEST
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACON U120 URINE ANALYZER, MODEL U111-101
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MISSION BREATH ALCOHOL DETECTOR
FDA 510(k)
FDA Class 1
·Clinical Toxicology
On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PALLIKARIS BRUSH
FDA 510(k)
FDA Class 1
·Ophthalmic
CLAREON MONARCH IV IOL Delivery System
FDA 510(k)
FDA Class 1
·Ophthalmic
CUSTOMCORNEA MEASUREMENT DEVICE (CCMD)
FDA 510(k)
FDA Class 1
·Ophthalmic
ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
AMCON SLIP IN MYDRIATIC SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic