AIXPLORER

FDA 510(k)

FDA Class 2 ·Radiology

Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems

FDA 510(k)

FDA Class 2 ·Radiology

SuperSonic HepaVu

FDA 510(k)

FDA Class 2 ·Radiology

ES Series V2

FDA 510(k)

FDA Class 2 ·Radiology

Embosphere Microspheres

FDA 510(k)

FDA Class 2 ·Cardiovascular

EmboCube Embolization Gelatin

FDA 510(k)

FDA Class 2 ·Cardiovascular

Iga, Fitc, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Iga, Fitc, Antigen, Antiserum, Control

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·DIASORIN ETI-HA-IGMK PLUS

AIXPLORER

FDA 510(k)

FDA Class 2 ·Radiology

AIXPLORER

FDA 510(k)

FDA Class 2 ·Radiology

MODULAR PORP AND TORP MODEL TBD

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NASOPHARYNGOSCOPE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

DESKREM-1000

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AUDIO EXPERT AUDIOMETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

TruDi Curette

FDA 510(k)

FDA Class 2 ·Neurology

Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MACHIDA NASOPHARYNGO-LARYNGOSCOPE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat