1,088 results
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50ms
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Sources: EU EUDAMED, US FDA
Filters
FDA Pre Market Approval
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Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC MODEL 7250 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (AF ONLY STUDY)
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·VISTAKON (SENOFILCON A) CONTACT LENSES
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM
Intravascular Radiation Delivery System
FDA Pre-Market Approval
FDA Class 3
·GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·IMMULITE/IMMULITE 1000 FREE PSA AND IMMULITE 2000 FREE PSA
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·USCI GRUNTZIG DILACA CATHETER
System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
FDA Pre-Market Approval
FDA Class 3
·COLOGUARD
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODEL 304 (ULTRA C-LOOP)
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·ANCURE ENDOGRAFT SYSTEM/ILIAC BALLOON CATHETER
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC REVO MRI SURESCAN PACING SYSTEM
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·LIAISON® XL MUREX HBsAg Qual assay and Control
System, Photopheresis, Extracorporeal
FDA Pre-Market Approval
FDA Class 3
·UVAR PHOTOPHERESIS SYSTEM
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·HCII HPV TEST (DIGENE HPV TEST USING HYBRID CAPTURE II TECHNOLOGY)
System, Rf/Microwave Hyperthermia, Cancer Treatment
FDA Pre-Market Approval
FDA Class 3
·BSD 1000 HYPERTHERMIA SYSTEM
Kit, Rna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·APTIMA HPV 16 18/45 GENOTYPE ASSAY
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT
Stent, Carotid
FDA Pre-Market Approval
FDA Class 3
·XACT CAROTID STENT SYSTEM
Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
FDA Pre-Market Approval
FDA Class 3
·INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
Transcervical Contraceptive Tubal Occlusion Device
FDA Pre-Market Approval
FDA Class 3
·ESSURE SYSTEM
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·POSTERIOR CHAMBER INTRAOCULAR LENSES