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

D3 (PHEMFILCON A) UV OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES

FDA 510(k)

FDA Class 2 ·Ophthalmic

Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)

FDA 510(k)

FDA Class 2 ·General Hospital

BEL-GEN Cold Storage Solution

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PERF-GEN Pulsatile Perfusion Solution

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RM4 Control Unit

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Nasogastric Feeding Tubes - ENFit Port - PVC

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Pediatric Nasogastric Feeding Tubes - Single ENFit Port

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology