512 results
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23ms
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Sources: EU EUDAMED, US FDA
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Classification: FDA Class 2
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FDA 510(k)
FDA Class 2
·Neurology
REGALTECH MAXISCOPE
FDA 510(k)
FDA Class 2
·Ophthalmic
TELEMEDCARE HEALTH MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
COMPUMEDICS SOMTE PSG RECORDING SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
Nurochek-Pro System
FDA 510(k)
FDA Class 2
·Neurology
Precision AI Surgical Planning System (PAI-SPS)
FDA 510(k)
FDA Class 2
·Orthopedic
ALBUMIN REAGENT - BROMCRESOL GREEN METHOD
FDA 510(k)
FDA Class 2
·Clinical Chemistry
THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Towako Transmyometrial Embryo Transfer Set
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Quicktome
FDA 510(k)
FDA Class 2
·Radiology
DentaTOOTH
FDA 510(k)
FDA Class 2
·Dental
Field Orthopaedics Micro Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
TROPHON CHEMICAL INDICATOR
FDA 510(k)
FDA Class 2
·General Hospital
Nurochek-II System
FDA 510(k)
FDA Class 2
·Neurology
ADAPT Tissue
FDA 510(k)
FDA Class 2
·Cardiovascular
AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CREATININE REAGENT - PICRIC ACID METHOD
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Gems Vitrification Set, Gems Warming Set
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TRUMPET VALVE HANDLE WITH 3-METRE TUBING, SINGLE SPIKE, 5MM CANNULA, TRUMPET VALVE HANDLE WITH 3-METRE TUBING, DOUBLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
360CAS Knee
FDA 510(k)
FDA Class 2
·Neurology