2,784 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·EXPRESS/EXPRESS2 CORONARY STENT SYSTEM
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Edwards Commander Delivery System
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Precision, Precision Novi, Precision Spectra, Spectra WaveWriter, Precision Montage, and Precision Montage MRI Spinal Co
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBC-IGM ON COBAS E 411
Lens, Intraocular, Phakic
FDA Pre-Market Approval
FDA Class 3
·STAAR SURGICAL IMPLANTABLE COLLAMER LENSES
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·MED-EL Cochlear Implant System
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·ACRYSOF INTRAOCULAR LENSES
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·VENTAK(R) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·InterStim Therapy System, Verify Evaluation System (SNS Urinary)
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·CURRENT RF AND PROMOTE RF FAMILY OF DEVICES
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Lead Repair Kit, ENDOTAK RELIANCE® S, ENDOTAK RELIANCE®, ENDOTAK RELIANCE® SG, ENDOTAK RELIANCE® G, RELIANCE 4-FRONT, A
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·HBSAG IMMULITE ASSAY
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBC-IGM ON COBAS E 601
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Accessory, Cap, Accessory, Plug
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ACUITY Stylet, Straight 0.013, 45cm, ACUITY Stylet, Straight 0.013, 52cm, ACUITY Stylet, Straight 0.013, 59cm, ACUITY St
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·EMBLEM S-ICD, EMBLEM MRI S-ICD
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·CURRENT RF AND PROMOTE RF FAMILY OF DEVICES
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·ACUITY Spiral, Accessory, Slit Suture Sleeve, ACUITY X4 Straight, ACUITY X4 Spiral S, ACUITY X4 Spiral L, Slit Sutu
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ANTI-HBC IMMULITE ASSAY
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·- ESSENTIO SR, ESSENTIO DR, SSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR