Prosthesis, Testicular

FDA Pre-Market Approval

FDA Class 3 ·MENTOR SALINE-FILLED TESTICULAR PROSTHESIS

Prosthesis, Testicular

FDA classification

FDA Class 3 ·Prosthesis, Testicular

Delta Fab GmbH

Manufacturer

🇩🇪 Germany

PAREDES MAPEDO FAB SPA

Manufacturer

🇮🇹 Italy

FAE Famed Łódź S.A.

Manufacturer

🇵🇱 Poland·7 Basic UDI-DIs·38 Devices

FACS Loader

FDA registration

Becton, Dickinson and Company, BD Biosciences·1 product·🇺🇸 United States

FACS CLEAN

FDA registration

Avantor Performance Materials Poland S.A.·1 product·🇵🇱 Poland

Clip-FAB

FDA registration

CLIP-FAB R&D MEDICAL INSTRUMENTS, S.L.·1 product·🇪🇸 Spain

Hang Fai Optical Industrial Co.

Manufacturer

🇨🇳 China

Shinjin Medics Inc.

Manufacturer

🇰🇷 South Korea·2 Basic UDI-DIs·2 Devices

Shanghai PZ Medical Technology Co., Ltd.

Manufacturer

🇨🇳 China·11 Basic UDI-DIs·11 Devices

Liaoning Dihao Biotechnology Co., Ltd.

Manufacturer

🇨🇳 China

DM Orthotics Ltd

Manufacturer

31 Basic UDI-DIs·148 Devices·1 Importer

HIDROFER SA

Manufacturer

🇵🇹 Portugal·49 Basic UDI-DIs·56 Devices

SRS Medical Systems, Inc.

Manufacturer

🇺🇸 United States

ASEP HEALTHCARE LTD

Manufacturer

2 Importers

3F-Fit Fabricando Faber doo

Manufacturer

🇷🇸 Serbia·3 Basic UDI-DIs·4 Devices·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ

PHAKOS

Manufacturer

🇫🇷 France

SillHa paper Test Strip Kit

FDA registration

ARKRAY FACTORY USA, INC.·1 product·🇺🇸 United States

Joimax® Intracs® System

FDA registration

ERGOSURG·1 product·🇩🇪 Germany