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

OFM GmbH

Importer

🇩🇪 Germany

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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VITATRON

IFM-Gerbershagen GmbH

Importer

🇩🇪 Germany·5 Manufacturers

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

FDA Pre-Market Approval

FDA Class 3 ·T SPOT-TB TEST

NA

FDA UDI

MEDTRONIC, INC.·00763000181185·CABLE 2292 MDT GLBL

EFMED SP. Z O.O.

Importer

🇵🇱 Poland·2 Manufacturers

GfM mbH

System producer

🇩🇪 Germany

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

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

pfm medical cpp

System producer

🇨🇭 Switzerland

SANGUESA SA

Importer

🇪🇸 Spain·10 Manufacturers

pfm medical gmbh

Importer

🇩🇪 Germany·8 Manufacturers

System, Mycolic Acid Analysis, Mycobacterium Tuberculosis

FDA classification

FDA Class 1 ·System, Mycolic Acid Analysis, Mycobacterium Tuberculosis

International Business Compendious of Sweden

Authorized representative

🇸🇪 Sweden·47 Manufacturers·1 Device

COMED SAS

Importer

🇫🇷 France·25 Manufacturers