Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ISOFLEX S PERMANENT PACING LEAD MODELS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ilivia Neo 7 VR-T, Intica Neo 7 and 5 VR-T, Ilivia Neo 7 VR-T DX, and Intica Neo 7 and 5 VR-T DX

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR-T

DKT WomanCare Global Services SAS

Importer

🇫🇷 France·1 Manufacturer

Elos Accurate Customized Abutment, Elos Prosthetic Screw

FDA 510(k)

FDA Class 2 ·Dental

Ambu® aScope™ Colon; Ambu® aBox™ 2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ULTRASOUND SCANNER, TYPE 2400

FDA 510(k)

FDA Class 2 ·Radiology

SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TRIOS Ready Tip

FDA 510(k)

FDA Class 2 ·Dental

Hydrozid Precise

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PEDIATRIC ARTERIAL CANNULA

FDA 510(k)

FDA Class 2 ·Cardiovascular

EmbryoSlide+ ic8 dish

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ULTRASOUND SCANNER PRO FOCUS, MODEL 2202

FDA 510(k)

FDA Class 2 ·Radiology

ICS Dizcovery (1091)

FDA 510(k)

FDA Class 2 ·Neurology

PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS

FDA 510(k)

FDA Class 2 ·General Hospital

ULTRASOUND SCANNER MINI FOCUS, MODEL 1402

FDA 510(k)

FDA Class 2 ·Radiology

K-SYSTEMS WORK STATIONS, TYPE L-13W, L-13E, L-13ES, L-13ET, L-13EM, L-23, L-23E, L-24, L-24E, L-25, L-25E, L-26, L-26E,L

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION

FDA 510(k)

FDA Class 2 ·Neurology