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