462 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 1
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INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC
FDA 510(k)
FDA Class 1
·Microbiology
ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC)
FDA 510(k)
FDA Class 1
·Microbiology
ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II
FDA 510(k)
FDA Class 1
·Microbiology
NIPRO DENTAL NEEDLE
FDA 510(k)
FDA Class 1
·Dental
TGL FLEX REAGENT CARTRIDGE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2
FDA 510(k)
FDA Class 1
·Clinical Chemistry
IODOSORB POWDER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
IODOSORB GEL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DIMENSION EXL WITH LM SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AIRCO PRESSURE REGULATORS
FDA 510(k)
FDA Class 1
·Anesthesiology
DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516
FDA 510(k)
FDA Class 1
·Clinical Toxicology
AIRCO NITROUS OXIDE REGULATOR
FDA 510(k)
FDA Class 1
·Anesthesiology
AIRCO 2000 SERIES FLOWMETERS
FDA 510(k)
FDA Class 1
·Anesthesiology
Zip 4 Skin Closure Device
FDA 510(k)
FDA Class 1
·General Hospital
Atellica CH Magnesium (Mg)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator
FDA 510(k)
FDA Class 1
·Clinical Chemistry
INFLUENZA HI PRESERUM
FDA 510(k)
FDA Class 1
·Microbiology