325 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODIFIED J & C LOOP MODEL PA36
Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
FDA Pre-Market Approval
FDA Class 3
·Gambro Prismaflex TPE 2000 Set
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM
Lens, Multifocal Intraocular
FDA Pre-Market Approval
FDA Class 3
·ACRYSOF IQ RESTOR +3.0 D MULTIFOCAL TORIC INTRAOCULAR LENS
Nitric Oxide Generator And Delivery System
FDA Pre-Market Approval
FDA Class 3
·LungFit PH
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·LCS TOTAL KNEE SYSTEM: REMAINING ULTRAHIGH MOLECULAR WEIGHT POLYETHYLENE DEVICES
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·CERAMAX Ceramic Total Hip System
Drug-Coated Peripheral Transluminal Angioplasty Catheter
FDA Pre-Market Approval
FDA Class 3
·IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Drug-Eluting Peripheral Transluminal Angioplasty Catheter
FDA Pre-Market Approval
FDA Class 3
·IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, IN.PACT 018 Paclitaxel-Coated
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
FDA Pre-Market Approval
FDA Class 3
·InterStim Therapy System, Verify Evaluation System
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·SynchroMed Infusion System, Ascenda Intrathecal Catheters
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA Pre-Market Approval
FDA Class 3
·Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense
Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·InterStim Therapy System, Verify Evaluation System
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Itrel, Synergy, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify, and Vectris Spinal Cord St
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·HOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENS
Glue, Surgical, Arteries
FDA Pre-Market Approval
FDA Class 3
·BIOGLUE SURGICAL ADHESIVE
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
FDA Pre-Market Approval
FDA Class 3
·UROLOGIX TARGIS SYSTEM
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·HYDROVIEW COMPOSITE HYDROGEL FOLDABLE UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS