1,840 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBC IGM ON MODULAR ANALYTICS E170
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·TIER A LENS MODELS UPB360GN AND UP320F
Stent, Superficial Femoral Artery
FDA Pre-Market Approval
FDA Class 3
·GORE VIABAHN ENDOPROSTHESIS
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Elecsys Anit-HBc IgM
Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
FDA Pre-Market Approval
FDA Class 3
·NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·GORE TAG THORACIC ENDOPROSTHESIS
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·SIMPSON CORONARY ATHEROCATH(R) (SCA(TM))DEV.MOD.
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODELS AC-21/AC-21B ANTERIOR CHAMBER IOL
Stent, Superficial Femoral Artery
FDA Pre-Market Approval
FDA Class 3
·GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
FDA Pre-Market Approval
FDA Class 3
·NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·ZENITH FLEX AAA ENDOVASCULAR GRAFT
Permanent Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP
Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·Oxford Partial Knee System
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODEL UPB240 POSTERIOR CHAMBER INTRAOCULAR LENSES
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM
Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
FDA Pre-Market Approval
FDA Class 3
·NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODELS 019B, 019C, 019E, 019F, 019J, & 019K
Diagnostic Low Electric Field
FDA Pre-Market Approval
FDA Class 3
·MARGINPROBE SYSTEM
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·COOK ZENITH RENU AAA ANCILLARY GRAFT
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODELS 019B, 019C, 019E, 019F, 019J, & 019K