508 results
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70ms
·
Sources: EU EUDAMED, US FDA
Drug-Coated Peripheral Transluminal Angioplasty Catheter
FDA Pre-Market Approval
FDA Class 3
·IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant Thoracic Stent Graft (FreeFlo Tapers Line Extens
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·Resolute Onyx Rapid Exchange Zotarolimus-Eluting Coronary Stent System, Resolute Onyx Over The Wire Zotarolimus-Eluting
Acid, Hyaluronic, Intraarticular
FDA Pre-Market Approval
FDA Class 3
·GEL-ONE
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·ACS MULTI-LINK RX DUET/OTW DUET CORONARY STENT SYSTEM
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
Prosthesis, Breast, Inflatable, Internal, Saline
FDA Pre-Market Approval
FDA Class 3
·IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·PALMAZ-SCHATZ CROWN BALLOON EXPANDABLE STENT WITH POWERGRIP OVER-THE-WIRE DELIVERY SYSTEM
Sealant, Dural
FDA Pre-Market Approval
FDA Class 3
·DURASEAL DURAL SEALANT SYSTEM
Lens, Contact, Orthokeratology, Overnight
FDA Pre-Market Approval
FDA Class 3
·BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS FOR OVERNIGHT WEAR FOR BAUSH & LOMB VISION SHAPING TREATMENT
FDA Pre-Market Approval
OSTEONICS CONSTRAINED ACETABULAR INSERT
System, Photopheresis, Extracorporeal
FDA Pre-Market Approval
FDA Class 3
·THERAKOS UVAR(R) PHOTOPHORESIS SYSTEM
Implant, Hearing, Active, Middle Ear, Partially Implanted
FDA Pre-Market Approval
FDA Class 3
·VIBRANT SOUNDBRIDGE
Dressing, Wound And Burn, Interactive
FDA Pre-Market Approval
FDA Class 3
·TRANSCYTE
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·DURALOC OPTION CERAMIC ON CERAMIC HIP SYSTEM
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·LCS TOTAL KNEE SYSTEM
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ABBOTT HBE (RDNA) EIA
Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
FDA Pre-Market Approval
FDA Class 3
·LCS UNI KNEE SYSTEM
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNDIAGNOSTICS PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATOR