347 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 1
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BEAUSOLEIL FRAME
FDA 510(k)
FDA Class 1
·Ophthalmic
PATHO DX STREP D
FDA 510(k)
FDA Class 1
·Microbiology
IMMULITE 2000; CORTISOL CALIBRATION VERIFICATION MATERIAL, FOLIC ACID CALIBRATION VERIFICATION MATERIAL, VITAMIN B12 CAL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NON-PRES SUNGLASSES/SPEC FRAMES (PLASTIC & METAL)
FDA 510(k)
FDA Class 1
·Ophthalmic
IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NETRA WORKSTATION SYSTEM & NETRA MD SOFTWARE
FDA 510(k)
FDA Class 1
·Radiology
CARDIAC MARKER CONTROL MODULE, MODEL CCCM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DERMATOUCH LATEX GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
IMMULITE PROLACTIN
FDA 510(k)
FDA Class 1
·Clinical Chemistry
COAT-A-COUNT 17-ALPHA-HYDROXYPROGESTERONE RIA KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
COAT-A-COUNT PROLACTIN IRMA #:IKPR1, IKPR2
FDA 510(k)
FDA Class 1
·Clinical Chemistry
IMMULITE C-PEPTIDE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3
FDA 510(k)
FDA Class 1
·Clinical Toxicology
IGF-I BY EXTRACTION; INSULIN-LIKE GROWTH FACTOR I
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PROSTATE SPECIFIC ANTIGEN (RSA) CONTROL MODDULE (PSACM)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1
FDA 510(k)
FDA Class 1
·Microbiology
CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
STERILE LATEX SURGEON'S GLOVES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MILENIA DATA REDUCTION
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LAD MODEL 633 LUMINOMETER
FDA 510(k)
FDA Class 1
·Clinical Chemistry