Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System

FDA classification

FDA Class 2 ·Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System

ACIES

FDA 510(k)

FDA Class 2 ·Radiology

BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ACTHK-PR RIA KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Reverso Pro System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

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