2,565 results · 48ms · Sources: EU EUDAMED, US FDA

CRYOSTAB® GAC

Basic UDI-DI
EU MDR · Eu Md Class 1 ·GROUPE SOBER SAS·3 devices

CRF-GBC-B

Basic UDI-DI
EU MDD · Eu Md Class 2b ·Cambridge Interventional LLC·1 device

Flexi-Seal PROTECT Fecal Management System

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

Dimension EXL LOCI BRAHMS Procalcitonin (PCT)

FDA 510(k)
FDA Class 2 ·Microbiology

DIMENSION EXL WITH LM SYSTEM

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

GentleCath Glide Intermittent Urinary Catheter

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

DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516

FDA 510(k)
FDA Class 1 ·Clinical Toxicology

GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter

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

INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS

FDA 510(k)
FDA Class 2 ·Hematology

INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5

FDA 510(k)
FDA Class 2 ·Hematology

Atellica® IM High-Sensitivity Troponin I (TnIH)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)

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

N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC

FDA 510(k)
FDA Class 2 ·Immunology

Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

GentleCath Glide Intermittent Catheter

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