34 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
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