4,549 results · 45ms · Sources: EU EUDAMED, US FDA

HIGH SPEED EMG MODULE

FDA 510(k)
FDA Class 2 ·Neurology

OHMEGA

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MMS VIDEO OPTION

FDA 510(k)
FDA Class 2 ·Radiology

SOLAR GI SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO SOLAR GI

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SOLAR GI

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SOLAR GI

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SET ZZ BASE CU-AS - AS-V-WSM 4.7 - 5.0 - 5.5 (White Scanmarker and scr

FDA UDI
ZIRKONZAHN SRL·D800ZBCD10134·Compatible with Cumdente implants Set consisti...

Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel

FDA classification
FDA Class 2 ·Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel

ARCHITECT Total PSA Reagent Kit (LN 6C06-27, 6C06-35)

FDA registration
ABBOTT GmbH·5 products·🇩🇪 Germany

ARCHITECT Total PSA Reagent Kit (LN 6C06-27, 6C06-35)

FDA registration
ABBOTT LABORATORIES·5 products·🇺🇸 United States

ARCHITECT Total PSA Reagent Kit (LN 6C06-27, 6C06-35)

FDA registration
ABBOTT IRELAND·5 products·🇮🇪 Ireland

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·SIEMENS IMMULITE PSA AND THIRD GENERATION PSA ASSAYS ON THE IMMULITE, IMMULITE 1000, 2000 AND IMMULITE 2500 ANALYZERS

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT Total PSA Reagent/Calibrator/Control Kit

FDA Pre-Market Approval
Atellica® IM Complexed PSA (cPSA) Assay

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval
FDA Class 3 ·Elecsys free PSA Test System, Biotin remediation

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval
FDA Class 3 ·ACCESS HYBRITECH FREE PSA REAGENT/CALIBRATOR KIT

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·Atellica IM Prostate-Specific Antigen (PSA) Assay

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval
FDA Class 3 ·Atellica IM Prostate-Specific Antigen (PSA) Assay

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·Elecsys total PSA (100/200 tests) Immunoassay