NA

FDA UDI

GMDASZ manufacturing Co., Ltd.·06970341670160·DS1015, electrode pad, 10x15cm butterfly, dual ...

Implanted Fecal Incontinence Device

FDA classification

FDA Class 3 ·Implanted Fecal Incontinence Device

Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis

FDA classification

FDA Class 3 ·Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis

Microspheres Radionuclide

FDA classification

FDA Class 3 ·Microspheres Radionuclide

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction

FDA classification

FDA Class 3 ·Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction

Ventricular (Assist) Bypass

FDA classification

FDA Class 3 ·Ventricular (Assist) Bypass

Transcatheter Septal Occluder

FDA classification

FDA Class 3 ·Transcatheter Septal Occluder

uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)

FDA registration

Shenzhen Mindray Bio-Medical Electronics Co.,LTD·12 products·🇨🇳 China

uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)

FDA registration

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.·12 products·🇨🇳 China

Computer, Diagnostic, Pre-Programmed, Single-Function

FDA classification

FDA Class 2 ·Computer, Diagnostic, Pre-Programmed, Single-Function

Cement, Bone, Vertebroplasty, Pre-Formed, Modular

FDA classification

FDA Class 2 ·Cement, Bone, Vertebroplasty, Pre-Formed, Modular

D P Medical Systems (Ireland) Limited

Importer

🇮🇪 Ireland·6 Manufacturers

Bioptimal International Pte. Ltd.

System producer

🇸🇬 Singapore

HD 60149099 0001

Certificate

MDD Annex II (excluding section 4)·GME German Medical Engineering GmbH·TÜV Rheinland LGA Products GmbH·5 Basic UDI-DIs

HD60123813

Certificate

MDD Annex II (excluding section 4)·GME German Medical Engineering GmbH·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI

Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty

FDA classification

FDA Class 2 ·Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty

IntelliVue Patient Monitor MP5, MP5T, MP5SC SW Rev. J.20

FDA registration

Philips Electronics Ltd·13 products·🇨🇦 Canada

IntelliVue Guardian Software

FDA registration

Philips Electronics Ltd·13 products·🇨🇦 Canada

IntelliVue Guardian Software

FDA registration

Philips Medizin Systeme Boeblingen GmbH·13 products·🇩🇪 Germany

IntelliVue Patient Monitor MP5, MP5T, MP5SC SW Rev. J.20

FDA registration

Philips Medizin Systeme Boeblingen GmbH·13 products·🇩🇪 Germany