5,404 results · 45ms · Sources: EU EUDAMED, US FDA

HemoSphere Advanced Monitor (HEM1)

FDA registration
BECTON, DICKINSON AND COMPANY·2 products·🇺🇸 United States

McKesson Cardiology Hemo

FDA registration
Change Healthcare Israel Ltd.·2 products·🇮🇱 Israel

HeartKey® Rhythm

FDA registration
B-SECUR LIMITED·2 products·🇬🇧 United Kingdom

Holter System, models SE-2003 and SE-2012

FDA registration
EDAN INSTRUMENTS, INC.·2 products·🇨🇳 China

Ultiri Measurement System

FDA registration
Abbott Vascular Netherlands·2 products·🇳🇱 Netherlands

ULTRASAFE FACEMASKS

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Akzenta International SA·1 device

ORBIS - PATIENT TOWELS

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Akzenta International SA·11 devices

Stool sample collection set filled with extraction buffer IDK Extract® (dilution 1:100)

Device
EU IVDR · Eu Ivd Class A ·Immundiagnostik AG·On the market

Stool sample preparation system filled with extraction buffer IDK Extract® (dilution 1:100)

Device
EU IVDR · Eu Ivd Class A ·Immundiagnostik AG·On the market

Stool sample preparation system filled with extraction buffer IDK Extract® (dilution 1:100

Device
EU IVDR · Eu Ivd Class A ·Immundiagnostik AG·On the market

Stool sample preparation system filled with extraction buffer IDK Extract® (dilution 1:100)

Device
EU IVDR · Eu Ivd Class A ·Immundiagnostik AG·On the market

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·iSert® Pre-loaded System, iSert Preloaded IOL System, IPURE Pre-loaded System, PreVue Pre-loaded System

MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY); MULTISCAN ULTRASOUND SYSTEM, MODEL M0001

FDA 510(k)
FDA Class 2 ·Radiology

FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Drip tray for ink

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Copan Wasp S.r.l.·1 device

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ACRYSERT DELIVERY SYSTEM

FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ACRYSERT C DELIVERY SYSTEM

Black Eye Endoscopic Marker Ink

Basic UDI-DI
EU MDD · Eu Md Class 2b ·The Standard. Co., Ltd.·1 device

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval
FDA Class 3 ·GYNECARE INTERCEED Absorbable Adhesion Barrier