HAEMONETICS 1000ML COMPONENT BAG

FDA 510(k)

FDA Class 2 ·Hematology

BLOOD FREEZING BAG

FDA 510(k)

FDA Class 2 ·Hematology

ScreenDx

FDA 510(k)

FDA Class 2 ·Radiology

PLASMA FLEX

FDA 510(k)

FDA Class 2 ·Hematology

Fibresolve

FDA 510(k)

FDA Class 2 ·Radiology

Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRANSFER PAK 4R 9006

FDA 510(k)

FDA Class 2 ·Hematology

EPISCREEN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Quantisal II Oral Fluid Collection Device

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TFX-LT2000 Therapy Light

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AF Laser

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Sepsis ImmunoScore

FDA 510(k)

FDA Class 2 ·General Hospital

Quantisal™ II Oral Fluid Collection Device

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle

FDA 510(k)

FDA Class 2 ·Cardiovascular

REMY Medical Therapy Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Q-CLEAR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FREEDOM ND: YAG LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Onycho Laser V

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)

FDA 510(k)

FDA Class 2 ·Cardiovascular

IQ-UIP

FDA 510(k)

FDA Class 2 ·Radiology