364 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 1
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SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM
FDA 510(k)
FDA Class 1
·Hematology
MILENIA (TM) LH
FDA 510(k)
FDA Class 1
·Clinical Chemistry
RIONET HEARING AID HB-71P
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG
FDA 510(k)
FDA Class 1
·Microbiology
SEM Scanner (Model 200)
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/
FDA 510(k)
FDA Class 1
·Clinical Chemistry
IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S
FDA 510(k)
FDA Class 1
·Clinical Toxicology
RIONET HEARING AID HB-73
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
EYEDENTITY EYEWEAR
FDA 510(k)
FDA Class 1
·Ophthalmic
IMMULITE PROGESTERONE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
IMMULITE HGH
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DOUBLE ANTIBODY ALBUMIN FOR DETECT MICROALBUMINURI
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MILENIA(TM) PROLACTIN (MKPR1,5)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CKMB CONTROL - LEVEL 1,2,3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PINWORM EGG COLLECTOR
FDA 510(k)
FDA Class 1
·Microbiology
RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MILENIA(TM) FSH (MKFS1,5)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PREALBUMIN IMMUNOLOGICAL NL TEST KIT
FDA 510(k)
FDA Class 1
·Immunology