Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VIRTUOSO & ENTRUST

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·COSMODERM 1 HUMAN-BASED COLLAGEN, COSMODERM 2 HUMAN-BASED COLLAGEN AND COSMOPLAST HUMAN-BASED COLLAGEN

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·BELLAFILL

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBsAg Next Qualitative I Qualitative Confirmatory/ Alinity i HBsAg Next Qualitative I Alinity i HBsAg Next Con

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM THERAPY SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED(TM) INFUSION SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Restore, ltrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Resume, Specify, and Vectris Spinal Cord Stimula

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM THERAPY SYSTEM

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Atellica® IM Hepatitis B surface Antigen II (HBsll), Atellica® IM Hepatitis B surface Antigen 11 Confirmatory (HBsll Con

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·BRAVA CRT-D, QUAD CRT-D, CONCERTO OCD,CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC II PROTECT ICD, MAXIMO II CRT-D, PROTECT

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D, Quard CRT-D; Brava CRT-D, Quard CRT-D; Claria MRI CRT-D, Quard CRT-DCompia MRI CRT-D, Quard CRT-D; Con

Organ Care System (Ocs) Heart System

FDA Pre-Market Approval

FDA Class 3 ·Organ Care System (OCS) Heart

Organ Care System (Ocs) Heart System

FDA Pre-Market Approval

FDA Class 3 ·Organ Care System™ (OCS™) Heart

Organ Care System (Ocs) Heart System

FDA Pre-Market Approval

FDA Class 3 ·OCS Heart System

Organ Care System (Ocs) Heart System

FDA Pre-Market Approval

FDA Class 3 ·Organ Care System (OCS) Heart System

Organ Care System (Ocs) Heart System

FDA Pre-Market Approval

FDA Class 3 ·Organ Care System (OCS) Heart System

Organ Care System (Ocs) Heart System

FDA Pre-Market Approval

FDA Class 3 ·Organ Care System (OCS) Heart System

Organ Care System (Ocs) Heart System

FDA Pre-Market Approval

FDA Class 3 ·Organ Care System™ (OCS™) Heart

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·INTERCEED (TC7) ABSORBABLE ADHESION BARRIER