249 results · 19ms · Sources: EU EUDAMED, US FDA

DIGITAL BLOOD PRESSURE METER - MODEL NO.: BPM883

FDA 510(k)
FDA Class 2 ·Cardiovascular

MEMOMETAL INTRA-MEDULLARY BONE FASTENER

FDA 510(k)
FDA Class 2 ·Orthopedic

PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120

FDA 510(k)
FDA Class 2 ·Hematology

ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

MODIFICATION TO PENTRA 60 AND PENTRA 60C+

FDA 510(k)
FDA Class 2 ·Hematology

HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5

FDA 510(k)
FDA Class 2 ·Hematology

CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ABX PENTRA 400 : CRP

FDA 510(k)
FDA Class 2 ·Immunology

ABX PENTRA DX 120: OPTION SPS EVOLUTION

FDA 510(k)
FDA Class 2 ·Hematology

ABX MICROS CRP 200, OPTION IM

FDA 510(k)
FDA Class 2 ·Hematology

ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

BLOOD PRESSURE METER MODEL NO. BPM888

FDA 510(k)
FDA Class 2 ·Cardiovascular

Newclip Patient-matched instrumentation non sterile PSI

FDA 510(k)
FDA Class 2 ·Orthopedic

PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Activmotion Range

FDA 510(k)
FDA Class 2 ·Orthopedic