26 results · 53ms · Sources: EU EUDAMED, US FDA

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ENDOTAK RELIANCE G/SG LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ENDOTAK RELIANCE S /GS /G

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ENDOTAK RELIANCE G/SG DEFIBRILLATION LEADS AND G/SG WITH 4-SITE CONNECTOR DEFIBRILLATION LEADS

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·SOF-SENSOR GLUCOSE SENSOR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ENDOTAK RELIANCE G/SG WITH 4-SITE CONNECTOR DEFIBRILLATION LEADS, ENDOTAK RELIANCE G/SG DEFIBRILLATION LEADS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·ALGES(TM) (HEFILCON A) CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·ALGES(TM) (HEFILCON A) CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·ALGES(TM) (HEFILCON A) CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·ALGES(TM) (HEFILCON A) CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·ALGES(TM) (HEFILCON A) CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·ALGES(TM) (HEFILCON A) CONTACT LENS

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template andIntegra Omnigraft Dermal Regenerati

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·Alinity i AFP Reagent Kit

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval
FDA Class 3 ·Alinity i Free PSA Reagent Kit

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

FDA Pre-Market Approval
FDA Class 3 ·Alinity i Total PSA Reagent Kit

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ENDOTAK RELIANCE G/SG LEAD MODELS 0180-0187

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ENDO RELIANCE/ S/G/SG/DF4 DEFIBRILLATION LEADS

Lens, Contact (Polymethylmethacrylate)

FDA Pre-Market Approval
FDA Unclassified ·THE BOSTON LENS II ALGES(R) BIFOCAL CONTACT LENS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ENDOTAK RELIANCE S, ENDOTAK RELIANCE G/SG, ENDOTAK RELIANCE 4-SITE LEAD FAMILY