SEJONG Surgical Gown Soft

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL,

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SPORT-ELEC, MODELS DUO CT5 SLIMNESS AND CT5 SLIMNESS

FDA 510(k)

FDA Class 2 ·Physical Medicine

PHARAON LIPO

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SMOOTHKIT+

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DENTRIa series

FDA 510(k)

FDA Class 2 ·Radiology

MAGLIFE C/MAGLIFE C PLUS

FDA 510(k)

FDA Class 2 ·Cardiovascular

ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIQ FUNCTION XPRESS

FDA 510(k)

FDA Class 2 ·Radiology

INTEGRATED REGISTRATION

FDA 510(k)

FDA Class 2 ·Radiology

ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT

FDA 510(k)

FDA Class 2 ·Hematology

ABX MICROS ES 60 OT and ABX MICROS ES 60 CT

FDA 510(k)

FDA Class 2 ·Hematology

ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MICROS 60

FDA 510(k)

FDA Class 2 ·Hematology

PENTRA XLR

FDA 510(k)

FDA Class 2 ·Hematology

SURPASSON P5 NEWTRON

FDA 510(k)

FDA Class 2 ·Dental