10,000 results · 101ms · Sources: EU EUDAMED, US FDA

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FDA Pre-Market Approval
LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers

MEDIN TECH ZIRCONIA-CP10, SS1000

FDA 510(k)
FDA Class 2 ·Dental

SoundBite Crossing System - Peripheral (14P)

FDA 510(k)
FDA Class 2 ·Cardiovascular

ANDROFLOW - RESPIRATORY RATE MONITOR

FDA 510(k)
FDA Class 2 ·Anesthesiology

I-STETHOS LINK

FDA 510(k)
FDA Class 2 ·Cardiovascular

ECHO. AKHO

FDA 510(k)
FDA Class 2 ·Radiology

BIOLOGICAL SOUND MONITOR (BSM) SENSOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A

FDA 510(k)
FDA Class 2 ·Cardiovascular

DENTALMATIC TI PROSTHESIS AND DENTALMATIC TI-A PROSTHETIC

FDA 510(k)
FDA Class 2 ·Dental

SoundBite® Crossing System XS Peripheral

FDA 510(k)
FDA Class 2 ·Cardiovascular

SoundBite Console, SoundBite Active Wire 18

FDA 510(k)
FDA Class 2 ·Cardiovascular

STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX

FDA 510(k)
FDA Class 2 ·Cardiovascular

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·VITROS IMMUNODIAGNOSTIC ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATORS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·Alinity i Anti-HBs Reagent Kit (2x100 Tests), Alinity i Anti-HBs Reagent Kit (2x600 Tests), Alinity i Anti-HBs Reagent K

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·Alinity i Anti-HBs Reagent Kit (2x 100 Tests), Alinity i Anti-HBs Reagent Kit (2x600 Tests), Alinity i Anti-HBs Reagent

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·VITROS IMMUNADIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATO

BD Centro Vena Acute Central Line (7 French Dual Lumen)

FDA 510(k)
FDA Class 2 ·General Hospital

BD Acute Central Line

FDA 510(k)
FDA Class 2 ·General Hospital

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ELECSYS ANTI-HBS TEST SYSTEM