FASTPACK CONTROL KIT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

FASTPACK TESTOSTERONE CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ICON POLYAXIAL PEDICLE SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ILT SAFE CROSS 0.035 SUPPORT CATHETER, MODEL C135SN1

FDA 510(k)

FDA Class 2 ·Cardiovascular

ILT SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1

FDA 510(k)

FDA Class 2 ·Cardiovascular

ILT SUPPORT CATHETER .014, MODEL C114LW1; ILT SUPPORT CATHETER ADVANCING MECHANISM, MODEL A11AM1

FDA 510(k)

FDA Class 2 ·Cardiovascular

SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [PERIPHERAL]

FDA 510(k)

FDA Class 2 ·Cardiovascular

FASTPACK FREE T4 IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO SAFE-STEER GUIDE WIRE SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

NEXFLEX TOTAL HIP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

NEXFLEX TOTAL HIP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

AirSculpt Body Contouring System (AIRS-1-SYS)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER

FDA 510(k)

FDA Class 2 ·Immunology

FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY

FDA 510(k)

FDA Class 1 ·Clinical Chemistry