725 results · 22ms · Sources: EU EUDAMED, US FDA

System, Hemodynamic, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CARDIOMEMS HF SYSTEM

Implant, Cochlear

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

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·LIFEPAK 15 monitor/defibrillator

Biologic Material, Dental

FDA Pre-Market Approval
FDA Class 3 ·Straumann Emdogain

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval
FDA Class 3 ·CollaPlug®, Absorbable Collagen Wound Dressing for Dental Surgery

Instrument, Glucose, Noninvasive Technology

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

MODEL 366-10 ADAPTAID STEP-DOWN ADAPTER

FDA 510(k)
FDA Class 3 ·Cardiovascular

MODEL 366-20 ADAPTAID STEP-DOWN ADAPTER

FDA 510(k)
FDA Class 3 ·Cardiovascular

MODEL 366-13 ADAPTAID STEP DOWN ADAPTER

FDA 510(k)
FDA Class 3 ·Cardiovascular

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·SYNCHROMED AND SYNCHROMED II IMPLANTABLE INFUSION PUMPS

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·VNS THERAPY SYSTEM

MODEL 366-28 ADAPTAID(TM) STEP-DOWN ADAPTER

FDA 510(k)
FDA Class 3 ·Cardiovascular

MODEL 366-23 ADAPTAID(TM) STEP-DOWN ADAPTER

FDA 510(k)
FDA Class 3 ·Cardiovascular

MODEL 366-27 ADAPTAID(TM) STEP-DOWN ADAPTER

FDA 510(k)
FDA Class 3 ·Cardiovascular

MODEL 366-12 ADAPTAID(TM) STEP-DOWN ADAPTER

FDA 510(k)
FDA Class 3 ·Cardiovascular

MODEL 366-12 ADAPTAID (TM) STEP-DOWN ADAPTER

FDA 510(k)
FDA Class 3 ·Cardiovascular

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval
FDA Class 3 ·Inspire Model 3028 Implantable Pulse Generator (IPG)

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM

Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation

FDA Pre-Market Approval
FDA Class 3 ·PINNACLE COMPLETE ACETABULAR HIP SYSTEM

Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation

FDA Pre-Market Approval
FDA Class 3 ·PINNACLE COMPLETE ACETABULAR HIP SYSTEM