10,000 results
·
224ms
·
Sources: EU EUDAMED, US FDA
Stimulator, Invasive Bone Growth
FDA Pre-Market Approval
FDA Class 3
·EBI OsteoGen Implantable Bone Growth Stimulators
Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·Oxford Partial Knee System - tibial tray and femoral components
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·BELOS A+ /BELOS A+/T, /KAINOX A+ 75/15, /KAINOX A+ 75/17
Stimulator, Invasive Bone Growth
FDA Pre-Market Approval
FDA Class 3
·SPF Implantable Spinal Fusion Stimulators
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·HeartMate 3 Left Ventricular Assist System
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·SIMPSON CORONARY ATHEROCATH-GTO
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·DEXCOM SEVEN AND SEVEN PLUS SYSTEM
Gastric Emptying Breath Test
FDA Pre-Market Approval
FDA Class 3
·13C-SPIRULINA GEBT/13C-SPIRULINA GASTRIC EMPTYING BREATH TEST (GEBT)
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·AMPLICOR HCV TEST,VERSION 2.0
FDA Pre-Market Approval
RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS
Agent, Absorbable Hemostatic, Collagen Based
FDA Pre-Market Approval
FDA Class 3
·AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) NON-WOVEN WEB
Extended Depth Of Focus Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·TECNIS SYMFONY EXTENDED RANGE OF VISION INTRAOCULAR LENS
Pulmonary Valve Prosthesis Percutaneously Delivered
FDA Pre-Market Approval
Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent
Agent, Absorbable Hemostatic, Collagen Based
FDA Pre-Market Approval
FDA Class 3
·AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FLOUR
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·Sientra Silicone Gel Breast Implants
Prosthesis, Penis, Inflatable
FDA Pre-Market Approval
FDA Class 3
·AMS 700 Inflatable Penile Prosthesis without InhibiZone
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne Liquid CDx (F1LCDx)
Device, Incontinence, Mechanical/Hydraulic
FDA Pre-Market Approval
FDA Class 3
·AMS 800 Artificial Urinary Sphincter with and without InhibiZone
FDA Pre-Market Approval
GEM III VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR(ICD)
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