1,516 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·RENEWAL 3 RF CONTAK & RENEWAL PG, LIVIAN CRT-D
Stent, Superficial Femoral Artery
FDA Pre-Market Approval
FDA Class 3
·ASTRON PULSAR STENT SYSTEM, PULSAR-18 STENT SYSTEM
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·MINILINK TRANSMITTER (MMT-7703) AND CGMS IPRO RECORDER (MMT-7709)
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·REFLECTION CERAMIC ACETABULAR HIP SYSTEM
Automated Insulin Dosing , Threshold Suspend
FDA Pre-Market Approval
FDA Class 3
·t:slim X2 Insulin Pump with Basal-IQ Technology
Automated Insulin Dosing , Threshold Suspend
FDA Pre-Market Approval
FDA Class 3
·MINIMED 530G INSULIN PUMP
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·OrganOx metra System
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·HEARTWARE VENTRICULAR ASSIST SYSTEM
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·MULTI-LINK RX TETRA(TM) CORONARY STENT SYSTEM/ MULTI-LINK OTW TETRA(TM) CORONARY STENT SYSTEM
Processor, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·PREPSTAIN INSTRUMENT
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·PROTOS PULSE GENERATOR (PROTOS VR AND PROTOS DR) AND B-K00.P.U AND A-K00.0.U PROGRAMMER SOFTWARE
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC.KAPPA 400 SERIES PACEMAKERS
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·ABBOTT ARCHITECT AFP ASSAY
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·CIBA VISION AIR OPTIX AQUA (LOTRAFILCON B) SOFT CONTACT LENSES
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Sequentia LT INS (Model 977005), Vanta INS with AdaptiveStim (Model 977006)
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·FRESHLOOK DIMENSIONS (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR UP TO 7 DAYS/6 NIGHTS (SPHERICAL
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA Pre-Market Approval
FDA Class 3
·Percept PC INS with BrainSense (Model B35200)
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·FRESHLOOK RADIANCE SPHERICAL AND TORIC (PHEMFILCON A) SOFT CONTACT LENSES
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD