EliA SmDP Immunoassay

FDA 510(k)

FDA Class 2 ·Immunology

ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed

FDA 510(k)

FDA Class 2 ·Immunology

Vivo 1, Vivo 2

FDA 510(k)

FDA Class 2 ·Anesthesiology

FLOLAB

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Healing Cap Multi-Unit Titanium

FDA 510(k)

FDA Class 2 ·Dental

Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SANPOINT MENSTRUAL TAMPON

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DTX Studio design

FDA 510(k)

FDA Class 2 ·Dental

EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay

FDA 510(k)

FDA Class 2 ·Immunology

DTX Studio Clinic

FDA 510(k)

FDA Class 2 ·Radiology

A-18 HEMODIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TRAX, POWERED WHEELCHAIR, MODEL 308686-00-0

FDA 510(k)

FDA Class 2 ·Physical Medicine

RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3

FDA 510(k)

FDA Class 2 ·Radiology

Suture-TOOL System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Multi4 System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PHASEAL PROTECTOR P14, P21, P28 AND P50

FDA 510(k)

FDA Class 2 ·General Hospital

ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING

FDA 510(k)

FDA Class 2 ·Microbiology

ScandiDos Delta4 Phantom+

FDA 510(k)

FDA Class 2 ·Radiology

DELTA4

FDA 510(k)

FDA Class 2 ·Radiology

Servo-air 4.0 Ventilator System

FDA 510(k)

FDA Class 2 ·Anesthesiology