36 results · 15ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Filters Fda510k ×

QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

AFP 17 X 4 AUTOMATIC FILM PROCESSOR

FDA 510(k)
FDA Class 2 ·Radiology

AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION)

FDA 510(k)
FDA Class 3 ·Cardiovascular

ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY

FDA 510(k)
FDA Class 2 ·Immunology

AFP SYSTEM PULSE GENERATOR MODEL 261/262

FDA 510(k)
FDA Class 3 ·Cardiovascular

AIA-PACK AFP CALIBRATION VERIFICATION TEST SET

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DSL ACTIVE AFP ELISA, MODEL DSL-10-8400

FDA 510(k)
FDA Class 2 ·Immunology

DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454

FDA 510(k)
FDA Class 2 ·Immunology

AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM

FDA 510(k)
FDA Class 2 ·Immunology

AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

FDA 510(k)
FDA Class 2 ·Immunology

IMMULITE 2000 AFP, BR-MA, AND OM-MA CALIBRATION VERIFICATION MATERIAL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211

FDA 510(k)
FDA Class 2 ·Immunology

UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION

FDA 510(k)
FDA Class 2 ·Immunology

DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600

FDA 510(k)
FDA Class 2 ·Immunology

EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL

FDA 510(k)
FDA Class 2 ·Neurology