4,090 results · 53ms · Sources: EU EUDAMED, US FDA

SCoV-2 Ag Detect Rapid Test

FDA 510(k)
FDA Class 2 ·Microbiology

Healgen Rapid COVID-19 Antigen Test

FDA 510(k)
FDA Class 2 ·Microbiology

cobas liat SARS-CoV-2 v2 nucleic acid test

FDA 510(k)
FDA Class 2 ·Microbiology

Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set

FDA 510(k)
FDA Class 2 ·Microbiology

Nano-Check™ COVID-19 Antigen Test

FDA 510(k)
FDA Class 2 ·Microbiology

Blanket, Neonatal Phototherapy

FDA classification
FDA Class 2 ·Blanket, Neonatal Phototherapy

Tabletop Sunlamp System

FDA classification
FDA Class 2 ·Tabletop Sunlamp System

Needle And Needle Set, Gastro-Urology, Reprocessed

FDA classification
FDA Class 2 ·Needle And Needle Set, Gastro-Urology, Reprocessed

Set, Dialysis, Single Needle (Co-Axial Flow)

FDA classification
FDA Class 2 ·Set, Dialysis, Single Needle (Co-Axial Flow)

Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617)

FDA 510(k)
FDA Class 2 ·Physical Medicine

IPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-1196B, D-1196W, D-1196C, D-1196C1, D-T099K, D-T099KW, D-T012, D-T012W)

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

E-CUBE 15

FDA 510(k)
FDA Class 2 ·Radiology

E-CUBE 15

FDA 510(k)
FDA Class 2 ·Radiology

E-CUBE 12

FDA 510(k)
FDA Class 2 ·Radiology

E-CUBE 7

FDA 510(k)
FDA Class 2 ·Radiology

E-CUBE INNO

FDA 510(k)
FDA Class 2 ·Radiology

E-CUBE 15 Diagnostic Ultrasound System

FDA 510(k)
FDA Class 2 ·Radiology

E-CUBE 5

FDA 510(k)
FDA Class 2 ·Radiology

Synxess Neurovascular Guidewire

FDA 510(k)
FDA Class 2 ·Cardiovascular

E-CUBE 7

FDA 510(k)
FDA Class 2 ·Radiology