2,000 results · 38ms · Sources: EU EUDAMED, US FDA

BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2

FDA 510(k)
FDA Class 2 ·Hematology

Dimension Vista MMB Assay

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION

FDA 510(k)
FDA Class 2 ·Radiology

Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices

FDA 510(k)
FDA Class 2 ·Orthopedic

DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454

FDA 510(k)
FDA Class 2 ·Immunology

Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors

FDA 510(k)
FDA Class 2 ·Cardiovascular

ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

INNOVANCE D-DIMER, MODEL OPBP09

FDA 510(k)
FDA Class 2 ·Hematology

LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DIMENSION VISA ENZ 2 CAL

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910)

FDA 510(k)
FDA Class 2 ·Cardiovascular

ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

EXL ANEM CAL, MODEL RC640

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Atellica CH Amylase_2 (AMY_2)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry