GAMMA CLQ

FDA 510(k)

FDA Class 2 ·Immunology

BINDAZYME CLQ CIC EIA KIT

FDA 510(k)

FDA Class 2 ·Immunology

OLYMPUS BF TYPE UC160-OL8

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LAS-R HUMAN COMPLEMENT CLQ TEST

FDA 510(k)

FDA Class 2 ·Immunology

CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

ELLIPSE JUVIA, MODEL 9EJU7465

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery