GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MEDICAL DISPLAY, MDC1900-1LG (1LR)

FDA 510(k)

FDA Class 2 ·Radiology

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·USE OF RED PLASTIC PLUG WITH CONCEPT -1 SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·USE OF RED PLASTIC PLUG WITH CONCEPT -1 SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·USE OF RED PLASTIC PLUG WITH CONCEPT -1 SOLUTION

GO-PEN®

FDA 510(k)

FDA Class 2 ·General Hospital

BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR

FDA 510(k)

FDA Class 2 ·Hematology

ELLIPSE FLEX PPT, MODEL 9ESF7255

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR

FDA 510(k)

FDA Class 2 ·Hematology

GetSet Surgical GoPLF! Posterior Lateral Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

ELLIPSE MULTIFLEX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ELLIPSE I2PL+/ELLIPSE MULTIFLEX+

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Ellipse Ydun

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ELLIPSE 12PL, MODEL 9ESL7228

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN

FDA 510(k)

FDA Class 2 ·Hematology