Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC SYNCHROMED INFUSION SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion System, Ascenda Intrathecal Catheters

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·IsoMed Infusion System

Reusable cold/hot gel compress

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Danyang Rapid Aid Hot and Cold Therapy Products Co., Ltd·10 devices

Human Care HC AB

Authorized representative

🇸🇪 Sweden

Eurobio Scientific

Importer

🇫🇷 France·8 Manufacturers

NOU-CLEAN SPRAY

FDA UDI

Nouvag AG·ENOU19849·Cleaning spray for Instruments and Motors 500ml

Global Regulatory Solutions HC B.V.

Authorized representative

🇳🇱 Netherlands·1 Manufacturer·1 Device

Magnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml)

FDA classification

Magnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml)

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCT HBSAG REAGENT PACK & CALIBRATOR & VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIRMATORY KI

Tasosol Europe B.V.

Importer

🇳🇱 Netherlands·6 Manufacturers

Tasosol Netherlands B.V.

Importer

🇳🇱 Netherlands·8 Manufacturers

NAVION SMART-WIRE(TM) CATHETER LOCATION SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

MEDIMAC BANDAGE

FDA 510(k)

FDA Class 1 ·General Hospital

TOP GUN

FDA 510(k)

FDA Class 2 ·General Hospital

INFUSION SET

FDA 510(k)

FDA Class 2 ·General Hospital

RXAIR 3000

FDA 510(k)

FDA Class 2 ·General Hospital

LYOFOAM EXTRA

FDA 510(k)

FDA Class 1 ·General Hospital

ACUVANCE PLUS SAFETY IV CATHETER, PROTECTIV PLUS SAFETY IV CATHETER, OPTIVA IV CATHETER

FDA 510(k)

FDA Class 2 ·General Hospital