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

LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HAEMONETICS 1400 ML THERAPEUTIC BAG

FDA 510(k)

FDA Class 2 ·Hematology

MLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53) Deletion FISH Probe Kit; EVI1 (MECOM) Breakapart FISH Probe Kit, Del(20q) Deletion FISH Probe Kit; AML1/ETO (RUNX1/RUNXIT1)) Translocation, Dual Fusi, CBFB (CBFB) /MYH11 Translocation, Dual Fusion FISH Probe Kit,Del(5q)Deletion FISH Probe Kit; Del(7q)Deletion FISH Probe Kit

FDA 510(k)

FDA Class 2 ·Medical Genetics

FOTONA XP ND: YAG LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

WavelinQ Plus EndoAVF System

FDA 510(k)

FDA Class 2 ·Cardiovascular

KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501

FDA 510(k)

FDA Class 2 ·Hematology

EMPTY TRANSFER BAG

FDA 510(k)

FDA Class 2 ·Hematology

DEROYAL SURGICAL, UMBILICUP

FDA 510(k)

FDA Class 2 ·Hematology