Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Enticos 4 DR, Enticos 4

HEALTHIUM MEDTECH LIMITED

Manufacturer

🇮🇳 India·1 Importer·3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., and 3EC International a.s.

AMEDA/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GE DATEX-OHMEDA AISYS

FDA 510(k)

FDA Class 2 ·Anesthesiology

C. DIFFICILE TOX A/B II

FDA 510(k)

FDA Class 1 ·Microbiology

SUNDASH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AMEDA/EGNELL DOLPHIN UMBILICAL CORD SEVERING DEVIC

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000

FDA 510(k)

FDA Class 2 ·Anesthesiology

Voluson Expert 22, Voluson Expert 20, Voluson Expert 18

FDA 510(k)

FDA Class 2 ·Radiology

Voluson Expert 22, Voluson Expert 20, Voluson Expert 18

FDA 510(k)

FDA Class 2 ·Radiology

GE DATEX-OHMEDA AVANCE

FDA 510(k)

FDA Class 2 ·Anesthesiology

LASER TRAP 100 LASER PLUME SMOKE EVACUATION FILTER

FDA 510(k)

FDA Class 1 ·Orthopedic

AMEDA AMECARE(R) NEONATAL INCUBATOR

FDA 510(k)

FDA Class 2 ·General Hospital

GE DATEX-OHMEDA AISYS

FDA 510(k)

FDA Class 2 ·Anesthesiology

CLOSTRIDIUM DIFFICILE TOX-A-TEST

FDA 510(k)

FDA Class 1 ·Microbiology

LOGIQ P10, LOGIQ P9, LOGIQ P8

FDA 510(k)

FDA Class 2 ·Radiology

LOGIQ P10, LOGIQ P9, LOGIQ P8

FDA 510(k)

FDA Class 2 ·Radiology

TECHLAB 1-HOUR TOX-A-TEST

FDA 510(k)

FDA Class 1 ·Microbiology

EMERGENCY PERCUTANEOUS CRICOTHYROIDOTOMY KIT,MODIF

FDA 510(k)

FDA Class 2 ·Anesthesiology

AESPIRE 7900, AESPIRE VIEW

FDA 510(k)

FDA Class 2 ·Anesthesiology