10,000 results
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82ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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TITAN DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
HCG MIDSTREAM PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
POSI-LINK
FDA 510(k)
FDA Class 2
·General Hospital
GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2
FDA 510(k)
FDA Class 2
·Hematology
AirSurgN Insufflator (10030/AirSurgN)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BD DIRECTIGEN EZ FLU A + B
FDA 510(k)
FDA Class 2
·Microbiology
VERIFYNOW-P2Y12 ASSAY
FDA 510(k)
FDA Class 2
·Hematology
IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400
FDA 510(k)
FDA Class 2
·Cardiovascular
GEN-PROBE PACE SYSTEM FOR NEISSERIA GONORRHOEAE
FDA 510(k)
FDA Class 2
·Microbiology
SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MEDICAL MULTI-IMAGE CAMERA-676
FDA 510(k)
FDA Class 2
·Radiology
APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER
FDA 510(k)
FDA Class 2
·Immunology
MACROPORE OS RECONSTRUCTION
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) Tigris
FDA 510(k)
FDA Class 2
·Microbiology
Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GESCO PER-Q-CATH REPAIR KIT
FDA 510(k)
FDA Class 2
·General Hospital
SOFTFORM FACIAL IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit
FDA 510(k)
FDA Class 2
·Microbiology
UNIKO PointCloud Knee Instruments
FDA 510(k)
FDA Class 2
·Orthopedic