Floy GmbH

Manufacturer

🇩🇪 Germany·TÜV Rheinland LGA Products GmbH

Hangzhou Clongene Biotech Co., Ltd.

Manufacturer

🇨🇳 China·7 Basic UDI-DIs·7 Devices·2 Importers·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

PERCUTANEOUS NEPHROSTOMY SETS (GUNTHER)

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

CAB2 COMPUTER ASSISTED BIOFEEDBACK

FDA 510(k)

FDA Class 2 ·Neurology

MEDIS 5MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One

FDA 510(k)

FDA Class 2 ·Dental

NON-STERILE, POWDER FREE, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (50 UG OR LESS)

FDA 510(k)

FDA Class 1 ·General Hospital

MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT

FDA 510(k)

FDA Class 2 ·Cardiovascular

PATHWAY ACCESS SHEATH CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NON-STERILE POWDER FREE, LATEX EXAMINATION GLOVES, POLYMER COATED WHITE COLOR, WITH PROTEIN LABELING, CONTAINS 50 MICROG

FDA 510(k)

FDA Class 1 ·General Hospital

ANGIOMED RENAL DILATION SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PERIO-FLOW nozzle

FDA 510(k)

FDA Class 1 ·Dental

ANGIO MED DISPOSABLE PRESSURE CONNECTORS

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

Dexter L6 System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VINYL EXAM GLOVES, POWDER-FREE, YELLOW

FDA 510(k)

FDA Class 1 ·General Hospital

TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY

FDA 510(k)

FDA Class 2 ·Dental

NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE

FDA 510(k)

FDA Class 1 ·General Hospital

INNOVA EPVISION 2.0, INNOVA EPVISION 2.0

FDA 510(k)

FDA Class 2 ·Radiology

SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI)

FDA 510(k)

FDA Class 2 ·Radiology