MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS

FDA 510(k)

FDA Class 2 ·General Hospital

PALL LEUKOCYTE REMOVAL FILTER, PLATELETS

FDA 510(k)

FDA Class 2 ·General Hospital

INTERFACE TRANSFUSION BLOOD FILTER #30

FDA 510(k)

FDA Class 2 ·General Hospital

INTERFACE 20 MICRON TRANSFUSION BLD. F.

FDA 510(k)

FDA Class 2 ·General Hospital

ALPHA MICRON 20 MICROAGGREGATE FILTER

FDA 510(k)

FDA Class 2 ·General Hospital

SEPACELL R-500 AND SEPACELL R-500A

FDA 510(k)

FDA Class 2 ·General Hospital

BLOOD FILTER, MICROEMBOLI-ATS-F10

FDA 510(k)

FDA Class 2 ·General Hospital

20 MICRON HIGH CAPACITY TRANS/FILTER

FDA 510(k)

FDA Class 2 ·General Hospital

PEDIATRIC MICROAGGREGATE BLOOD FILTER

FDA 510(k)

FDA Class 2 ·General Hospital

NEOCARE 20 MICRON BLOOD FILTER

FDA 510(k)

FDA Class 2 ·General Hospital

PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST)

FDA 510(k)

FDA Class 2 ·General Hospital

Alinity m BKV

FDA 510(k)

FDA Class 2 ·Microbiology

cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

FDA 510(k)

FDA Class 2 ·Microbiology

CHK B.V.

Importer

🇳🇱 Netherlands

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·PERFLURON

Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms

FDA classification

FDA Class 2 ·Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms

Dimension Vista THC Flex

FDA registration

SIEMENS HEALTHCARE DIAGNOSTICS INC.·10 products·🇺🇸 United States

No.2020-IVD/QS-008

Certificate

IVDD Annex IV (excluding sections 4, 6)·CTK Biotech Inc.·3EC International a.s.·1 Basic UDI-DI

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·MODEL 7421 ITREL 7424 ITREL II, 7425 ITREL III AND MODEL 7427 SYNERGY SPINAL CORD STIMULATION (SCS) SYSTEM

CBR Services GmbH

Importer

🇩🇪 Germany