580 results · 18ms · Sources: EU EUDAMED, US FDA

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)