1,479 results · 21ms · Sources: EU EUDAMED, US FDA

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