INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Medicare HTM

Importer

🇫🇷 France·5 Manufacturers

pfm medical ag

Authorized representative

🇩🇪 Germany·3 Manufacturers

pfm medical gmbh

Authorized representative

🇩🇪 Germany·3 Manufacturers

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI, ICD, DF-1 ICD, S DR ICD, XT DR ICD, XT VR ICD; Mirro MRI DR ICD, VR ICD; Primo MRI DR ICD, VR ICD; Visia AF M

Oregon Scientific

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ear, Nose & Throat Smart Otoscope

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Dongguan HEMS Electronic Technology Co., Ltd.·7 devices

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

FDA Pre-Market Approval

FDA Class 3 ·Evia HF /HF-T; Entovis HF/ HF-T ; Edora 8 HF-T; Entira 8 HF-1; Etrinsa 8 HF-T; Epyra 8 HF-T; Eluna 8 HF-T; Edora 8HF-T Q

HBM Medical

Authorized representative

🇮🇪 Ireland·1 Manufacturer·23 Devices

EFMED SP. Z O.O.

Importer

🇵🇱 Poland·2 Manufacturers

GfM mbH

System producer

🇩🇪 Germany

MEDICALDEVICE.ORG OÜ

Importer

🇪🇪 Estonia·2 Manufacturers

Bathophenanthroline, Colorimetry, Iron (Non-Heme)

FDA classification

FDA Class 1 ·Bathophenanthroline, Colorimetry, Iron (Non-Heme)

Ige, Ferritin, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Ige, Ferritin, Antigen, Antiserum, Control

pfm medical cpp

System producer

🇨🇭 Switzerland

Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

FDA classification

FDA Class 3 ·Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

Kidney Perfusion Kit

FDA classification

FDA Class 2 ·Kidney Perfusion Kit

Parenteral Administration Kit

FDA classification

FDA Class 2 ·Parenteral Administration Kit

D And C Tray

FDA classification

FDA Not Classified ·D And C Tray

PHICOGIS EUROPE SARL

Importer

🇫🇷 France·4 Manufacturers