HELONTIX VENT

FDA 510(k)

FDA Class 2 ·Anesthesiology

LEKSELL GAMMA KNIFE PERFEXION

FDA 510(k)

FDA Class 2 ·Radiology

ETEST FOR CEFTAZIDIME

FDA 510(k)

FDA Class 2 ·Microbiology

ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE

FDA 510(k)

FDA Class 2 ·Microbiology

SENTINEL, MODEL SP-001

FDA 510(k)

FDA Class 2 ·Radiology

Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray

FDA 510(k)

FDA Class 2 ·General Hospital

ETEST FOR GEMIFLOXACIN

FDA 510(k)

FDA Class 2 ·Microbiology

RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRT (ACUSON) NEEDLE GUIDE KIT, STERILE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT

FDA 510(k)

FDA Class 2 ·Neurology

ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut

FDA 510(k)

FDA Class 2 ·Immunology

MOSAIQ Oncology Information System

FDA 510(k)

FDA Class 2 ·Radiology

Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial

FDA 510(k)

FDA Class 2 ·Neurology

PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR CABLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

ELEKTA MICRODRIVE, MODEL 916716

FDA 510(k)

FDA Class 2 ·Neurology

DENZIR

FDA 510(k)

FDA Class 2 ·Dental

YSANPOINT) (MENSTRUAL) DIGITAL TAMPON

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ProTrach Dualcare

FDA 510(k)

FDA Class 2 ·Anesthesiology

Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Vivo 45 LS

FDA 510(k)

FDA Class 2 ·Anesthesiology