783 results · 19ms · Sources: EU EUDAMED, US FDA

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SOFTEC HDO

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Softec HD/ HD PS, Softec I, Softec HDO, Softec HDM IOLs

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·ELAVIEW 1.26 UG APPLICATION SOFTWARE FOR THE ORCHESTRA PROGRAMMER; RAM PATCHES ALTO P4 AND ALTO2 P3; AND HSO 2.70 SOFTWA

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·ORCHESTRA PROGRAMMER

Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·4Kscore Test

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SOFTEC HD,SOFTEC I,SOFTEC HD PS AND SOFTEC HDO

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SOFTEC HD, SOFTEC HD PS, SOFTEC I AND SOFTEC HDO DEVICES.

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Softec HD, Sotlec I, Softec HD PS, Softec HDO, Softec HDM

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SOFTEC HD; SOFTEC I; SOFTEC HD PS AND SOFTEC HDO IOLS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·HQL Softec HD, Softec I, Softec HD PS, Softec HDO, Softec HDM

Analyzer, Data, Obstetric

FDA Pre-Market Approval
FDA Class 3 ·STAN S31 FETAL HEART MONITOR

Analyzer, Data, Obstetric

FDA Pre-Market Approval
FDA Class 3 ·NEOVENTA'S STAN S31 FETAL HEART MONITOR

Analyzer, Data, Obstetric

FDA Pre-Market Approval
FDA Class 3 ·STAN S31 FETAL HEART MONITOR

Analyzer, Data, Obstetric

FDA Pre-Market Approval
FDA Class 3 ·NEOVENTA'S STAN S31 FETAL HEART MONITOR

Analyzer, Data, Obstetric

FDA Pre-Market Approval
FDA Class 3 ·NEOVENTA'S STAN S31 FETAL HEART MONITOR

Analyzer, Data, Obstetric

FDA Pre-Market Approval
FDA Class 3 ·STAN S31 FETAL HEART MONITOR

Analyzer, Data, Obstetric

FDA Pre-Market Approval
FDA Class 3 ·STAN S31 SYSTEM

Analyzer, Data, Obstetric

FDA Pre-Market Approval
FDA Class 3 ·STAN S31 FETAL HEART MONITOR

Analyzer, Data, Obstetric

FDA Pre-Market Approval
FDA Class 3 ·STAN S31 FETAL HEART MONITOR

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs