Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·FC2 FEMALE CONDOM

BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BCI WW1021 PC APPLICATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

BCI WW1030 PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

BCI 3180 PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

FC-1000 FLUOROSCOPIC IMAGING COMPUTER

FDA 510(k)

FDA Class 2 ·Radiology

LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA

FDA 510(k)

FDA Class 2 ·General Hospital

SHARPS CONTAINER 18 GALLON

FDA 510(k)

FDA Class 2 ·General Hospital

FLEXO DENTAL RESIN MATERIAL

FDA 510(k)

FDA Class 2 ·Dental

IRRIGATOR, BODY CAVITY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

3420 DIGIT PULSE OXIMETER, MODEL 3420

FDA 510(k)

FDA Class 2 ·Cardiovascular

CAPNOCHECK

FDA 510(k)

FDA Class 2 ·Anesthesiology

BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

BCI ADVISOR VITAL SIGNS MONITOR (9200)

FDA 510(k)

FDA Class 2 ·Cardiovascular

BCI ADVISOR VITAL SIGNS MONITOR (9200)

FDA 510(k)

FDA Class 2 ·Cardiovascular

BCI M4529A OEM DIGITAL HANDHELD OXIMETER, MODEL M4529A

FDA 510(k)

FDA Class 2 ·Cardiovascular

BCI 3403 SLEEP SCREENING PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM

FDA 510(k)

FDA Class 2 ·Cardiovascular

GFX NERVE ABLATION SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology