GEM SRL

Manufacturer

🇮🇹 Italy·28 Basic UDI-DIs·38 Devices·TUV Rheinland Italia SRL, ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', and TUV Rheinland Italia SRL

Sydney IVF Culture Oil

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SULLIVAN AUTOSET HOME NASAL CPAP SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

WEST NILE VIRUS IGM CAPTURE ELISA

FDA 510(k)

FDA Class 2 ·Microbiology

SIMPLIFY D-DIMER, MODEL DCGK1

FDA 510(k)

FDA Class 2 ·Hematology

EchoSolv AS

FDA 510(k)

FDA Class 2 ·Radiology

Australis Anterior Lumbar Cage System

FDA 510(k)

FDA Class 2 ·Orthopedic

AirFit N20

FDA 510(k)

FDA Class 2 ·Anesthesiology

Qlicksmart BladeFlask UNIVERSAL

FDA 510(k)

FDA Class 2 ·General Hospital

COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000) KITS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TOTAL BILIRUBIN REAGENT, CONCENTRATED

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Aurora® Anterior Lumbar Plate Sytstem

FDA 510(k)

FDA Class 2 ·Orthopedic

LD1 ISOENZYME REAGENT KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

THE TMJ APPLIANCE

FDA 510(k)

FDA Class 1 ·Dental

Zipbond

FDA 510(k)

FDA Class 2 ·Dental

XV Lung Ventilation Analysis Software

FDA 510(k)

FDA Class 2 ·Radiology

CALCIUM REAGENT-METHYL THYMOL BLUE METHOD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SignaSure Dual Mobility System

FDA 510(k)

FDA Class 2 ·Orthopedic

Uterine ElevatOR PRO with OccludOR Balloon

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology