Inhibitor, Peridural Fibrosis (Adhesion Barrier)

FDA Pre-Market Approval

FDA Class 3 ·ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·EBI BONE HEALING SYSTEM(R)

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LASERVISION/VISX EXCIMER LASER FOR PRK AND PTK (MOBILEXCIMER)

Automated Breast Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·Invenia ABUS Premium, Invenia ABUS Prime

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER LITHOTRIPTER (STATIONARY AND MOBILE)

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·Gore Viatorr TIPS

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·ECONOLITH LITHOTRIPTER

FIB

Basic UDI-DI

EU IVDD · Eu Ivd General ·TECO Medical Instruments, Production + Trading GmbH·1 device

FIB

Basic UDI-DI

EU IVDD · Eu Ivd General ·TECO Medical Instruments, Production + Trading GmbH·1 device

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC SYNCHROMED INFUSION SYSTEM

5-926-200-2106

Certificate

MDD Annex II (excluding section 4)·FIXIER SA DE CV·NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC)·2 Basic UDI-DIs

CE611677

Certificate

MDD Annex II Section 4·Lifetech Scientific (Shenzhen) Co., Ltd.·BSI Group The Netherlands B.V.·23 Basic UDI-DIs

The BAG II Disposable Resuscitator

Certificate

MDD Annex V·Laerdal Medical AS·DNV Product Assurance AS·1 Basic UDI-DI

M.2017.106.7946

Certificate

MDD Annex II Section 4·Tulpar Tıbbi Ürünler İthalat İhracat Sanayi ve Ticaret L.T.D Ş.T.İ·UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.·212 Basic UDI-DIs

2217576CE02

Certificate

MDD Annex II (excluding section 4)·VITROMED GmbH·DEKRA Certification B.V.·4 Basic UDI-DIs

1984-MDD-18-524

Certificate

MDD Annex II (excluding section 4)·ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETI·Kiwa Belgelendirme Hizmetleri A.Ş.·2 Basic UDI-DIs

0068/QCO-DM/166-2020

Certificate

MDD Annex II (excluding section 4)·Pulsenmore Ltd·MTIC InterCert S.r.l.·2 Basic UDI-DIs

DD 601492220001

Certificate

MDD Annex V·AT&M Biomaterials Co., Ltd.·TÜV Rheinland LGA Products GmbH·4 Basic UDI-DIs

DD601492220001

Certificate

MDD Annex V·AT&M Biomaterials Co., Ltd.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI

Fab, Antigen, Antiserum, Control

FDA classification

FDA Class 1 ·Fab, Antigen, Antiserum, Control