K-SNAP

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIGITRON 2, DIGITAL SUBSTRACTION ANGIO. SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

WVSM (WIRLESS VITAL SIGNS MONITOR)

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIGICAM LHP (DIGITAL LASER HIGH PERFORMANCE)

FDA 510(k)

FDA Class 2 ·Radiology

GX-770 X-RAY CONTROL, MODEL 46-404600G4

FDA 510(k)

FDA Class 2 ·Dental

Alinity m HSV 1 & 2 / VZV

FDA 510(k)

FDA Class 2 ·Microbiology

PRECISION UV (VASURFILCON A)

FDA 510(k)

FDA Class 2 ·Ophthalmic

Alinity m STI Assay

FDA 510(k)

FDA Class 2 ·Microbiology

RHIGENE MESACUP2 TEST- SM

FDA 510(k)

FDA Class 2 ·Immunology

PEDIATRIC DEFIB K-PADS

FDA 510(k)

FDA Class 2 ·Cardiovascular

K-APATITE 20-40 MESH K-APATITE 40-60

FDA 510(k)

FDA Class 2 ·Dental

DEFIB K-PADS

FDA 510(k)

FDA Class 2 ·Cardiovascular

WVSM (WIRELESS VITAL SIGNS MONITOR), MODEL 5.0

FDA 510(k)

FDA Class 2 ·Cardiovascular

K-DISPERSE

FDA 510(k)

FDA Class 2 ·Neurology

PORTABLE LIGHT CURING UNIT

FDA 510(k)

FDA Class 2 ·Dental

ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PERSONAL WARMING GEL

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

K-STIK DEFIBRILLATION PADS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)

FDA 510(k)

FDA Class 2 ·Microbiology