ORTHODONTIC CERAMIC BRACKET

FDA 510(k)

FDA Class 2 ·Dental

Medical Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Embosphere Microspheres

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SmartTarget

FDA 510(k)

FDA Class 2 ·Radiology

Access PCT

FDA 510(k)

FDA Class 2 ·Microbiology

Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set

FDA 510(k)

FDA Class 2 ·Microbiology

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls

FDA 510(k)

FDA Class 2 ·Microbiology

Access PCT, Access PCT Calibrators

FDA 510(k)

FDA Class 2 ·Microbiology

AMYSYSTEMS PTS50CG 50 DEGREE WEIGHT SHIFT POWER TILT SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

AMYSYSTEMS PTS50-50 DEGREE POWER TILT SYSTEM FOR MID-WHEEL OR FRONT-WHEEL DRIVE POWER WHEELCHAIRS.

FDA 510(k)

FDA Class 2 ·Physical Medicine

Alkaline Phosphatase

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness

FDA classification

FDA Class 2 ·Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness

Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

FDA classification

FDA Class 2 ·Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

Scaler, Ultrasonic

FDA classification

FDA Class 2 ·Scaler, Ultrasonic

System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer

FDA classification

FDA Class 2 ·System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer

EVERON

FDA 510(k)

FDA Class 2 ·Anesthesiology

Lite

FDA 510(k)

FDA Class 2 ·Physical Medicine

MIS CONNECT Conical Connection Abutment

FDA 510(k)

FDA Class 2 ·Dental

TEMP-A-SURE

FDA 510(k)

FDA Class 2 ·General Hospital

BB-613-BPM

FDA 510(k)

FDA Class 2 ·Cardiovascular