5,404 results · 41ms · Sources: EU EUDAMED, US FDA

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS

Computer, Diagnostic, Programmable

FDA classification
FDA Class 2 ·Computer, Diagnostic, Programmable

Binder, Perineal

FDA classification
FDA Class 1 ·Binder, Perineal

Right Ventricular Pressure algorithm

FDA registration
BECTON, DICKINSON AND COMPANY·6 products·🇺🇸 United States

HemoSphere ClearSight Module

FDA registration
BECTON, DICKINSON AND COMPANY·6 products·🇺🇸 United States

BENCHMARK ELECTRONICS, INC.

FDA registration
BENCHMARK ELECTRONICS, INC.·6 products·🇺🇸 United States

BENCHMARK ELECTRONICS, INC.

FDA registration
BENCHMARK ELECTRONICS, INC.·6 products·🇺🇸 United States

Viewfinder Remote

FDA registration
EDWARDS LIFESCIENCES LLC·6 products·🇺🇸 United States

HemoSphere ClearSight Module

FDA registration
EDWARDS LIFESCIENCES LLC·6 products·🇺🇸 United States

HemoSphere ClearSIght Module

FDA registration
EDWARDS LIFESCIENCES LLC·6 products·🇺🇸 United States

HemoSphere ClearSIght Module

FDA registration
BECTON, DICKINSON AND COMPANY·6 products·🇺🇸 United States

BENCHMARK ELECTRONICS, INC.

FDA registration
BENCHMARK ELECTRONICS, INC.·6 products·🇺🇸 United States

BENCHMARK ELECTRONICS, INC.

FDA registration
BENCHMARK ELECTRONICS, INC.·6 products·🇺🇸 United States

Right Ventricular Pressure algorithm

FDA registration
EDWARDS LIFESCIENCES LLC·6 products·🇺🇸 United States

Labware, Assisted Reproduction, Exempt

FDA classification
FDA Class 2 ·Labware, Assisted Reproduction, Exempt

EV1000

FDA UDI
Edwards Lifesciences LLC·00690103193473·PRESSURE CONTROLLER KIT

EV1000

FDA UDI
Edwards Lifesciences LLC·00690103193374·HEART REFERENCE SENSOR

BE19/819943491

Certificate
MDD Annex II (excluding section 4)·IQ Messenger B.V·SGS Belgium NV·1 Basic UDI-DI

2114129CE01

Certificate
IVDD Annex IV (excluding sections 4, 6)·IQ Products BV·DEKRA Certification B.V.·1 Basic UDI-DI

2114921

Certificate
IVDD Annex IV (excluding sections 4, 6)·IQ Products BV·DEKRA Certification B.V.·1 Basic UDI-DI