60 results
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16ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 1
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NEW BASE FOR ORTHODONTIC APPLIANCES
FDA 510(k)
FDA Class 1
·Dental
SENTINOL -ORTHODONTIC ARCH WIRE
FDA 510(k)
FDA Class 1
·Dental
GAC THUMB-SUCKING CONTROL APPLIANCE
FDA 510(k)
FDA Class 1
·Dental
ION-IMPLANTED NEO SENTALLOY
FDA 510(k)
FDA Class 1
·Dental
MESIAL LOOP BAR
FDA 510(k)
FDA Class 1
·Dental
ORTHODONTIC ELASTOMER
FDA 510(k)
FDA Class 1
·Dental
BIOFORCE WIRE
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
STABIDENT LOCAL ANESTHESIA SYSTEM
FDA 510(k)
FDA Class 1
·Dental
HANDCARE PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK
FDA 510(k)
FDA Class 1
·Immunology
ORTHOFAB WHEELCHAIR ULTIMA (RIGID FRAME MANUAL WHEELCHAIR)
FDA 510(k)
FDA Class 1
·Physical Medicine
ORTHOFAB WHEELCHAIR ASTRA (FOLDING MANUAL WHEELCHAIR)
FDA 510(k)
FDA Class 1
·Physical Medicine
DIMENSION EXL WITH LM SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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
HUMAN (IGG) SUBCLASS (EIA) KIT
FDA 510(k)
FDA Class 1
·Immunology