319 results · 41ms · Sources: EU EUDAMED, US FDA

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·SPL LEAD SYSTEM

Alinity i STAT High Sensitivity Troponin-I

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Cievka pupočná pre novorodenca CP-01

Device
EU MDD · Eu Md Class 2a ·GAMA GROUP a.s.·On the market·2 countries

TF-BP01 BLOOD PRESSURE MEASUREMENT SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

Eye Mask (EM01, EM02, EM03, EM04, EM05, EM06, EP01, EP02, EP03, EP04, EP05)

FDA registration
SHENZHEN SUNGROW LED TECHNOLOGY CO.,LTD·1 product·🇨🇳 China

SAVI®

FDA UDI
MERIT MEDICAL SYSTEMS, INC.·00884450434758·

NA

FDA UDI
GE Healthcare Finland Oy·00840682104104·

MEDINAUT MAX

FDA UDI
IMEDICOM CO., LTD.·08800038056138·N/A

Autoplaque for ORS Visual

FDA UDI
Object Research Systems (ORS) Inc·B332VIAP0100·Autoplaque is a post-processing add-on module f...

MEDINAUT MAX

FDA UDI
IMEDICOM CO., LTD.·08800038055599·MEDINAUT MAX Small AO Adaptor(Zimmer-Hall)

Blood Pressure Monitor LC-BP01

FDA UDI
APEMAN INTERNATIONAL CO., LIMITED·04897118930017·Upper Arm Type Intelligent Blood Pressure Monit...

E. coli reference strain O101

FDA UDI
Ssi Diagnostica A/S·05713106821077·Reference strain

Blood Pressure Monitor LC-BP01

FDA UDI
APEMAN INTERNATIONAL CO., LIMITED·04897118930024·Upper Arm Type Intelligent Blood Pressure Monit...

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval
FDA Class 3 ·PLASMAFLO

Opiate 2000 ng Reagent (OP2 1 x 250)

Device
EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·On the market·32 countries

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval
FDA Class 3 ·PLASMAFLO OP-05 W(A) ASAHI PLASMA SEPARATOR

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval
FDA Class 3 ·PLASMAFLO OP-05 W(A) ASAHI PLASMA SEPARATOR

Biograph mMR with syngo MR E11P-AP01 system software

FDA 510(k)
FDA Class 2 ·Radiology

E. coli O101 serum, 3 mL

FDA UDI
Ssi Diagnostica A/S·05713106458372·Rabbit antiserum, Ready to use

E. coli O101 serum, 1 mL

FDA UDI
Ssi Diagnostica A/S·05713106850954·Rabbit antiserum, Ready to use