iDart Lyme IgM ImmunoBlot Kit

FDA 510(k)

FDA Class 2 ·Microbiology

CENTROS CHRONIC HEMODIALYSIS CATHETER SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit

FDA 510(k)

FDA Class 2 ·Microbiology

iDart Lyme IgG ImmunoBlot Kit

FDA 510(k)

FDA Class 2 ·Microbiology

ASH ADVANCE HEMODIALYSIS CATHETER AND PROCEDURE KIT, MODELS; 15FR X 24CM, 15FR X 28CM, 15FR X 32CM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020

FDA 510(k)

FDA Class 2 ·Immunology

Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TELEMANOMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ATOMSPEC GF BLOOD LEAD WORKSTATION

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Single-use Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VYSIS D7S486/CEP 7 FISH PROBE KIT

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

VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)

FDA 510(k)

FDA Class 2 ·Hematology

2-Way 100% Silicone ClearTract Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

2-Way 100% Silicone Cleartract Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

2-Way 100% Silicone Cleartract Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Kerecis SecureMesh

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Noxturnal Web

FDA 510(k)

FDA Class 2 ·Neurology