1,479 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-HBS IMMUNOASSAY
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·CERAMIC TRANSCEND ARTICULATION SYSTEM
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODIFIED J & C LOOP POSTERIOR CHAMBER SINGLE PIECE
System, Rf/Microwave Hyperthermia, Cancer Treatment
FDA Pre-Market Approval
FDA Class 3
·CLINI-THERM MARK I/IV/ DIPOLE ARRAY APPLICATOR
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·VOYAGER NC CORONARY DILATATION CATHETER
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·CERAMIC TRANSCEND ARTICULATION SYSTEM
Dressing, Wound And Burn, Interactive
FDA Pre-Market Approval
FDA Class 3
·APLIGRAF
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODIFIED J-LOOP POSTERIOR CHAMBER IOL
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·CERAMIC TRANSCEND ARTICULATION SYSTEM
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·OSTEO CERAMIC HIP
Dressing, Wound And Burn, Interactive
FDA Pre-Market Approval
FDA Class 3
·APLIGRAF (GRAFTSKIN)
Agent, Bulking, Injectable For Gastro-Urology Use
FDA Pre-Market Approval
FDA Class 3
·DURASPHERE INJECTABLE BULKING AGENT
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Elecsys HBeAg Immunoassay
System, Rf/Microwave Hyperthermia, Cancer Treatment
FDA Pre-Market Approval
FDA Class 3
·CLINI-THERM MARK I/IV
Implant, Anti-Gastroesophageal Reflux
FDA Pre-Market Approval
FDA Class 3
·LINX REFLUX MANAGEMENT SYSTEM, IMPLANT AND SIZING TOOL
System, Rf/Microwave Hyperthermia, Cancer Treatment
FDA Pre-Market Approval
FDA Class 3
·CLINI-THERM MARK I/IV
Laparoscopic Contraceptive Tubal Occlusion Device
FDA Pre-Market Approval
FDA Class 3
·FALOPE-RING BAND AND APPLICATOR SYSTEMS
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·VOYAGER RX CORONARY DILATATION CATHETER
Intravascular Radiation Delivery System
FDA Pre-Market Approval
FDA Class 3
·GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM
Dressing, Wound And Burn, Interactive
FDA Pre-Market Approval
FDA Class 3
·APLIGRAF