588 results · 18ms · Sources: EU EUDAMED, US FDA

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TIER A MODELS 24050,24150,25050,25350-125 LENSES

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL 14660 UV ABSORBING POSTERIOR CHAMBER LENSES

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ACCUTECH SINGLE & THREE PIECE INTRAOCULAR LENSES

Catheter, Percutaneous (Valvuloplasty)

FDA Pre-Market Approval
FDA Class 3 ·INOUE-BALLOON Catheter

Catheter, Percutaneous (Valvuloplasty)

FDA Pre-Market Approval
FDA Class 3 ·INOUE BALLOON CATHETER

Catheter, Percutaneous (Valvuloplasty)

FDA Pre-Market Approval
FDA Class 3 ·INOUE BALLOON CATHETER

Catheter, Percutaneous (Valvuloplasty)

FDA Pre-Market Approval
FDA Class 3 ·TORAY INOUE BALLON CATHETER

Catheter, Percutaneous (Valvuloplasty)

FDA Pre-Market Approval
FDA Class 3 ·Toray Inoue Balloon Catheter

Catheter, Percutaneous (Valvuloplasty)

FDA Pre-Market Approval
FDA Class 3 ·Inoue-Balloon Catheter

Catheter, Percutaneous (Valvuloplasty)

FDA Pre-Market Approval
FDA Class 3 ·TORAY INOUE BALLOON CATHETER

Catheter, Percutaneous (Valvuloplasty)

FDA Pre-Market Approval
FDA Class 3 ·Inoue Balloon Catheter

Catheter, Percutaneous (Valvuloplasty)

FDA Pre-Market Approval
FDA Class 3 ·INOUE BALLOON CATHETER

Catheter, Percutaneous (Valvuloplasty)

FDA Pre-Market Approval
FDA Class 3 ·INOUE BALLOON CATHETER

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Reply SR, Reply Dr, Esprit SR, Esprit DR (2nd generation , i.e. V2 ) & (5TH generation i.e.V5)

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·MEMORYGEL BREAST IMPLANT

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·Silicone Gel Breast Implants

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·SILICONE-FILLED NATRELLE BIOCELL TEXTURED SHELL SURFACE

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·Sientra Silicone Gel Breast Implants

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·MENTOR MEMORYSHAPE BREAST IMPLANTS

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·MemoryGel Silicone Gel-Filled Breast Implants