476 results · 36ms · Sources: EU EUDAMED, US FDA

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·ARTUS CMV RGQ MDX KIT

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Tendril MRI, Assurity MRI, Endurity MRI family of Pacemakers

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Durata, Optisure

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs

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

FDA Pre-Market Approval
FDA Class 3 ·Avant™ HF, Neutrino™ NxT HF, Gallant ™ HF, Entrant™ HF, Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assu

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Microny family of Pacemakers

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval
FDA Class 3 ·Tendril STS, UltiPace

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Assurity, Assurity+, Endurity, Accent family of Pacemakers

Leadless Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·Aveir Leadless System

Coal Black Polymer

FDA UDI
JBC and Company·D851QQ0·Tinted Opaque Powder

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·therascreen PIK3CA RGQ PCR Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·therascreen PIK3CA RGQ PCR Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·THERASCREEN KRAS RGQ PCR KIT

QG-50-SE

FDA UDI
CARESTREAM HEALTH, INC.·60889974000429·QG-50-4 X-RAY SE GEN 50KW

QG-50-2

FDA UDI
CARESTREAM HEALTH, INC.·60889974000412·QG-50-2 X-RAY GEN 50KW 3 PHASE 208-240

QG-40-3

FDA UDI
CARESTREAM HEALTH, INC.·60889976573235·QG-400-3 QUEST GEN 32KW 3 PH 380-480

QG-40-SE

FDA UDI
CARESTREAM HEALTH, INC.·60889976571842·QG-400-4 QUEST GEN, 40kW STORED

QG-32-2

FDA UDI
CARESTREAM HEALTH, INC.·60889976573204·QG-320-2 QUEST GEN 32KW 3 PH 208-240

QG-40-2

FDA UDI
CARESTREAM HEALTH, INC.·60889971016294·QG-4000-2 ODYSSEY GEN 40KW 3 PH 208-240