208 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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INSULATIVE COATING FOR CARD. PULSE GEN
FDA 510(k)
FDA Class 3
·Cardiovascular
CYBERLITH IMPLANTABLE PULSE GEN. #253-02
FDA 510(k)
FDA Class 3
·Cardiovascular
MICROTHIN-PII BIPOLAR PULSE GEN. #0623
FDA 510(k)
FDA Class 3
·Cardiovascular
MODEL 327T UNIPOLAR CARDIAC PULSE GEN
FDA 510(k)
FDA Class 3
·Cardiovascular
PROLITH MODEL 21S CARDIAC PULSE GEN.
FDA 510(k)
FDA Class 3
·Cardiovascular
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·IMMULITE, IMMULITE 1000, IMMULITE 2000, and IMMULITE 2500 3rd gen PSA
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·S-ICD GEN 2, S-ICD EMBLEM, EMBLEM S-ICD ELECTRODE
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·MODELS 940 & 941 VISTA DDD GEN. & MODEL 2050 MODUL
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Subcutaneous Implantable Defibrillator (S-ICD) EMBLEM MRI, S-ICD Gen 2.
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·ZIMMER NEXT GEN LPS -FLEX MOBILE AND LPS-MOBILE BEARING KNEE
Device, Thermal Ablation, Endometrial
FDA Pre-Market Approval
FDA Class 3
·NovaSure Impedance Controlled Endometrial Ablation System
Kit, Rna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·Aptima HPV Assay
Kit, Rna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·APTIMA HPV 16 18/45 GENOTYPE ASSAY
Prostrate Cancer Genes Nucleic Acid Amplification Test System
FDA Pre-Market Approval
FDA Class 3
·PROGENSA PCA3 ASSAY
Kit, Rna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·APTIMA HPV ASSAY
Kit, Rna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·Aptima HPV Assay
Kit, Rna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·Aptima HPV Assay
Prostrate Cancer Genes Nucleic Acid Amplification Test System
FDA Pre-Market Approval
FDA Class 3
·Progensa PCA3 Assay
Kit, Rna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·Aptima HPV Assay
Kit, Rna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·APTIMA HPV 16 18/45 GENOTYPE ASSAY