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

EPISCREEN ORAL SPECIMEN COLLECTION DEVICE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GAMBRO HEMOFREEZE-BAG

FDA 510(k)

FDA Class 2 ·Hematology

LunulaLaser

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PHARMAFLEX CRYOGENIC BAG

FDA 510(k)

FDA Class 2 ·Hematology

PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

WavelinQ 4F EndoAVF System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Aspen Laser Systems Therapy Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Ellipsys Vascular Access System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ORAL-EZE ORAL FLUID COLLECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology