PRO HMPV+ ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

MAGNETIC RESONANCE DIAGNOSTIC SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Vivid iq

FDA 510(k)

FDA Class 2 ·Radiology

BIOCHEM 515 RESPIRATION MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

HEATER WIRE BREATHING CIRCUIT

FDA 510(k)

FDA Class 2 ·Anesthesiology

VARELISA RNP-SM ANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OPTIMA CT660

FDA 510(k)

FDA Class 2 ·Radiology

GRAMS NYLON NONABSORBABLE SUTURE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION

FDA 510(k)

FDA Class 2 ·Neurology

GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS

FDA 510(k)

FDA Class 2 ·Radiology

VOCALIS GEL

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

GE VOLUSON E8 ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

TRANSESOPHAGEAL ECHO TRANSDUCER

FDA 510(k)

FDA Class 2 ·Cardiovascular

POMC/PCSK1/LEPR CDx Panel

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE

FDA 510(k)

FDA Class 2 ·Radiology

MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION TO PROFLU+ ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

QWH-085 WRIST ARRAY COIL

FDA 510(k)

FDA Class 2 ·Radiology

APOLLO MULTI-RACIAL REFERENCE POPULATION

FDA 510(k)

FDA Class 2 ·Radiology