551 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
×
COULTER 5C CELL CONTROL
FDA 510(k)
FDA Class 2
·Hematology
VARIAN ESOPHAGUS BOUGIE APPLICATOR
FDA 510(k)
FDA Class 2
·Radiology
COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
FDA 510(k)
FDA Class 2
·Hematology
COULTER LH 750 HEMATOLOGY ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
COULTER LIN-X LINEARITY CONTROL, MODEL A81196
FDA 510(k)
FDA Class 2
·Hematology
COULTER 6C CELL CONTROL, MODELS 628027 & A59925
FDA 510(k)
FDA Class 2
·Hematology
VARIAN HIGH ENERGY LINEAR ACCELERATOR
FDA 510(k)
FDA Class 2
·Radiology
Bed, Pediatric Open Hospital
FDA classification
FDA Class 2
·Bed, Pediatric Open Hospital
ALLURA 3D-CA, RELEASE 1
FDA 510(k)
FDA Class 2
·Radiology
PULSERA
FDA 510(k)
FDA Class 2
·Radiology
Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIMENSION DRUG CALIBRATOR, MODEL DC22B
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIMENSION ALDL CALIBRATOR, MODEL DC131
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Atellica CH Amylase_2 (AMY_2)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Atellica® CH Diazo Direct Bilirubin (D_DBil)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D
FDA 510(k)
FDA Class 2
·Hematology
STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C
FDA 510(k)
FDA Class 2
·Hematology