580 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Processor, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·THINPREP SLIDES
Stimulator, Hypoglossal Nerve, Implanted, Apnea
FDA Pre-Market Approval
FDA Class 3
·Inspire II Upper Airway Stimulator
Processor, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·ThinPrep Processors and ThinPrep Imaging System
OVALITH P-BP BIPOLAR CARDIAC PACEMAKER
FDA 510(k)
FDA Class 3
·Cardiovascular
Processor, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·BD PrepStain System, BD Totalys MultiProcessor, BD Totalys SlidePre, BD SurePath Liquid-based Pap Test
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM
Processor, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·THINPREP 2000 SYSTEM
Sensor, Electro-Optical (For Cervical Cancer)
FDA Pre-Market Approval
FDA Class 3
·LUMA CERVICAL IMAGING SYSTEM
Processor, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·BD PREPSTAIN SYSTEM
Reader, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·THINPREP (R) IMAGING SYSTEM
Reader, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·ThinPrep Integrated Imager
System, Hemodynamic, Implantable
FDA Pre-Market Approval
FDA Class 3
·Cordella Pulmonary Artery Sensor System (CorPASS)
Reader, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·AUTOPAP SYSTEM
Processor, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·PREPSTAIN SYSTEM
Processor, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·PREPSTAIN SYSTEM
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·AMVISC (R)
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·AMVISC 0.8 ML SYRINGE AND AMVISC PLUS, O.8 ML SYRINGE
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·VISCOAT Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscoelastic System, and DISCOVISC Ophthalmic Viscosurgic
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (OVD)