538 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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MAYO HIP PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
EFAI PACS Picture Archiving and Communication System
FDA 510(k)
FDA Class 2
·Radiology
EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
FDA 510(k)
FDA Class 2
·Radiology
EFAI RTSuite CT HN-Segmentation System
FDA 510(k)
FDA Class 2
·Radiology
EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)
FDA 510(k)
FDA Class 2
·Radiology
EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)
FDA 510(k)
FDA Class 2
·Radiology
DFS-2100
FDA 510(k)
FDA Class 2
·Radiology
IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
DFV CPG COLPOSCOPE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OsseOne Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
OsseOne Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
VECTRA LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CorticaLINK Spinal Fusion Platform
FDA 510(k)
FDA Class 2
·Orthopedic
MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT
FDA 510(k)
FDA Class 2
·Neurology
Kangaroo Feeding Tube with IRIS Technology
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VertebraLINK Fusion Platform
FDA 510(k)
FDA Class 2
·Orthopedic
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator