22 results · 56ms · Sources: EU EUDAMED, US FDA

Healing abutments, dental

FDA registration
WILLO AB·1 product·🇸🇪 Sweden

Ortopedic Implants

FDA registration
WILLO AB·1 product·🇸🇪 Sweden

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·CORETHERM SYSTEM MICROWAVE THERMOTHERAPY

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·IPULSE CIRCULATORY SUPPORT SYSTEM

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval
FDA Class 3 ·GAMBRO AB PLASMAFILTER PF 2000N AND EXCORIM KB MAXO PLASMAFILTER

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval
FDA Class 3 ·AMS 700 INFLATABLE PENILE PROSTHESIS

Implanted Fecal Incontinence Device

FDA Pre-Market Approval
FDA Class 3 ·AMS ACTICON NEOSPHINCTER-ARTIFICIAL BOWL SPHINCTER (ABS)

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·AMS 800 ARTIFICIAL URINARY SPHINCTER (AUS)

Biologic Material, Dental

FDA Pre-Market Approval
FDA Class 3 ·STRAUMANN EMDOGAIN

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·AB-HAVK, ETI-AB-HAVK, ETI-AB-HAVK PLUS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·DEMA/DIVA IMPLANTABLE PULSE GENERATORS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·GEM & MARQUIS FAMILY ICD'S

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ACTIVITRAX PACEMAKER FAMILY

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC JEWEL/GEM ICD'S

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC/VITATRON CARELINK PROGRAMMER

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC INSYNC (TM) BIVENTRICAL PACING SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·KAPPA 400 PACEMAKER FAMILY

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC GEM ICD

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·LEGEND PLUS PACEMAKER FAMILY

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC KAPPA/SIGMA PACEMAKER FAMILIES