34 results · 18ms · Sources: EU EUDAMED, US FDA

ZOLL SUREPOWER SINGLE BAY CHARGER

FDA 510(k)
FDA Class 3 ·Cardiovascular

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·InterStim Therapy System, Verify Evaluation System

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·Interstim Therapy System, Verify Evaluation System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·SKINVIVE™ by Juvederm

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·SKINVIVE by Juvéderm

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Skinvive by Juvéderm

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Skinvive™ by Juvéderm

Implantable Cardioverter Defibrillator (Non-Crt)

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

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Skinvive™ by Juvéderm®

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Skinvive™ by Juvéderm®

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·ROTAGLIDE(TM) LUBRICANT

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY ANTI-HER 2INEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·BIOELECTRON SPINALPAK II SPINE FUSION STIMULATOR

HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE

FDA 510(k)
FDA Class 3 ·Cardiovascular

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA and ALTRUA 2 supported by LATITUDE Consult

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA and ALTRUA 2 supported by LATITUDE Consult

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ADVANTIO, INGENIO, VITALIO, FORMIO ESSENTIO, ACCOLADE, PROPONENT, AND ALTRUA 2 SUPPORTED BY LATITUDE CONSULT ONLY) (PACE

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·AED Plus and Fully Automatic AED Plus

Device, Impotence, Mechanical/Hydraulic

FDA classification
FDA Class 3 ·Device, Impotence, Mechanical/Hydraulic