WEC-WASH, CATALOG NO. 850-115

FDA 510(k)

FDA Class 1 ·General Hospital

WEC-KLEEN, CATALOG N. 850-102

FDA 510(k)

FDA Class 1 ·General Hospital

WECK-KREEM, CATALOG NO. 850-155

FDA 510(k)

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·INSYNC CRT-D & CONCERTO/CONSULTA CRT-D/MAXIMO II CRT-D & VARIOUS INSYNC FAMILES ODF ICDS

ONE STEP Malaria P.F/P. V Tri-line Rapid Test (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

ONE STEP Malaria P.F/P. V Tri-line Rapid Test (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CDF-BOBATH-10

Basic UDI-DI

EU MDR · Eu Md Class 1 ·MOBERCAS SL·1 device

CDF-30-PC

Basic UDI-DI

EU MDR · Eu Md Class 1 ·MOBERCAS SL·1 device

G-EYE System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Ambu® aScope™ Colon; Ambu® aBox™ 2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VMA ASSAY KIT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DiLumen Endolumenal Interventional Platform

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FUJINON COLONOSCOPES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HVA EIA KIT YAMASA

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FUJIFILM Endoscope Models EC-600HL and EC-600LS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AO FLEXIBLE FIBER OPTIC S/COLONOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VS-200 VIDEO SIGMOIDOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190I

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology