52 results · 23ms · Sources: EU EUDAMED, US FDA

DJP UNIPOLAR

FDA 510(k)
FDA Class 3 ·Cardiovascular

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·EDP 30 EXTERNAL DUAL CHAMBER PACEMAKER

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·HARMONY HIRESOLUTION BIONIC EAR SYSTEM

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·DURASPHERE EXP

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·DURASPHERE EXP

LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP

FDA 510(k)
FDA Class 3 ·Cardiovascular

LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 45-UP

FDA 510(k)
FDA Class 3 ·Cardiovascular

LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 60-UP

FDA 510(k)
FDA Class 3 ·Cardiovascular

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

FDA Pre-Market Approval
FDA Class 3 ·SIENTRA SILICONE GEL BREAST IMPLANTS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ICS 3000/EDP 30/CARDIOMESSENGER

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·Protego EP PASSION

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Protego EP PASSION

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·EP Passion Initiative

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval
FDA Class 3 ·TRULIGN TORIC WEB-BASED TORIC CALCULATOR

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval
FDA Class 3 ·enVista One-Piece Hydrophobic Acrylic Toric Intraocular Lens (Model MX60T)

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval
FDA Class 3 ·TRULIGN TORIC WEB BASED TORIC CALCULATOR

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval
FDA Class 3 ·TECNIS Toric 1-Piece Intraocular Lenses (IOL)

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval
FDA Class 3 ·ELASTIC AND ELASTIMIDE ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval
FDA Class 3 ·CRYSTALENS AND TRULIGN TORIC INTRAOCULAR LENSES (IOLS)

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval
FDA Class 3 ·UV-ABSORBING SILICONE POSTERIOR CHAMBER IOLS W/TORIC OPTIC