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

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CAPSUREFIX & CRYSTALLINE ACT FIX

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·ISOLINE 2CR AND ISOLINE 2CT LEADS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·SWIFT(TM) 1CT SERIES 4040 DEFIBRILLATION LEAD

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·ISOLINE 2CR, ISOLINE 2CT STEROID ELUTING PACING LEADS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·PARADYM VR 8750,PARADYM DR8750,ISOLINE 2CT-ISOLINE 2CR

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·Immulite/Immulite 1000 PSA/Immulite 2000 PSA

Bronchial Thermoplasty System

FDA Pre-Market Approval
FDA Class 3 ·ALAIR BRONCHIAL THERMOPLASTY SYSTEM

Instrument, Glucose, Noninvasive Technology

FDA Pre-Market Approval
FDA Class 3 ·GLUCOWATCH G2 BIOGRAPHER

Artificial Iris

FDA Pre-Market Approval
FDA Class 3 ·CustomFlex Artificial Iris

Artificial Iris

FDA Pre-Market Approval
FDA Class 3 ·CustomFlex ArtificialIris

Instrument, Glucose, Noninvasive Technology

FDA Pre-Market Approval
FDA Class 3 ·GLUCOWATCH G2 BIOGRAPHER

Instrument, Glucose, Noninvasive Technology

FDA Pre-Market Approval
FDA Class 3 ·GLUCOWATCH G2 BIOGRAPHER

Instrument, Glucose, Noninvasive Technology

FDA Pre-Market Approval
FDA Class 3 ·GLUCOWATCH G2 BIOGRAPHER: MODIFIED GLUCOWATCH G2 BIOGRAPHER & AUTOSENSOR

Instrument, Glucose, Noninvasive Technology

FDA Pre-Market Approval
FDA Class 3 ·GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER

Artificial Iris

FDA Pre-Market Approval
FDA Class 3 ·CustomFlex Artificial Iris

Instrument, Glucose, Noninvasive Technology

FDA Pre-Market Approval
FDA Class 3 ·GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER

Artificial Iris

FDA Pre-Market Approval
FDA Class 3 ·CustomFlex Artificial Iris

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CAPSUREFIX LEAD; CAPSUREFIX NOVUS LEAD; SUREFIX LEAD;VITATRON CRYSTALLINE ACTIVE FIXATION LEAD; VITATRON CRYSTALLINE ACT

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD,SUREFIX LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD, VITATRON CRYSTALLINE ACT