Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·THUNDER HIGH SCAFFORDING OVER-THE-WIRE AND RAPID EXCHANGE SAPHENOUS VEIN GRAFT STENT SYSTEMS

Instrumenta Diagnostiska och Kirurgiska AB

Importer

🇸🇪 Sweden·2 Manufacturers

si_Mochi

FDA UDI

BIOSTONE CO. LIMITED·05060548020088·Silica induced bi-phase calcium phosphate ceram...

si_Mochi

FDA UDI

BIOSTONE CO. LIMITED·05060548020095·Silica induced bi-phase calcium phosphate ceram...

DT-8412SDT

FDA UDI

ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.·00886333677023·Single 1-way 60 drops, 60inch tube length Adset...

OTC Medical B.V.

Authorized representative

🇳🇱 Netherlands·1 Manufacturer

KADAKO ACCES SRL

Authorized representative

🇷🇴 Romania

2019/MDD

Certificate

MDD Annex II (excluding section 4)·MONTEFARMACO OTC SPA·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.·9 Basic UDI-DIs

0425-MED-004106-00

Certificate

MDD Annex II (excluding section 4)·MONTEFARMACO OTC SPA·ICIM S.P.A.·2 Basic UDI-DIs

0425-MED-004179-OO

Certificate

MDD Annex V·MONTEFARMACO OTC SPA·ICIM S.P.A.·1 Basic UDI-DI

0425-MED-004179-00

Certificate

MDD Annex V·MONTEFARMACO OTC SPA·ICIM S.P.A.·1 Basic UDI-DI

1919/MDD

Certificate

MDD Annex V·MONTEFARMACO OTC SPA·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.·4 Basic UDI-DIs

Ligamed β-TCP Putty 2 cc

Basic UDI-DI

EU MDD · Eu Md Class 3 ·Bonegraft Biomaterials Co.·1 device

Ligamed β-TCP Putty 1 cc

Basic UDI-DI

EU MDD · Eu Md Class 3 ·Bonegraft Biomaterials Co.·1 device

Ligamed β-TCP Putty 3 cc

Basic UDI-DI

EU MDD · Eu Md Class 3 ·Bonegraft Biomaterials Co.·1 device

Emboseal Non-Adhesive Embolization Agent (1cc)

Basic UDI-DI

EU MDD · Eu Md Class 3 ·İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş.·1 device

Emboseal Non-Adhesive Embolization Agent (1cc)

Basic UDI-DI

EU MDD · Eu Md Class 3 ·İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş.·1 device

Emboseal Non-Adhesive Embolization Agent (1cc)

Basic UDI-DI

EU MDD · Eu Md Class 3 ·İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş.·1 device

Emboseal Non-Adhesive Embolization Agent (1cc)

Basic UDI-DI

EU MDD · Eu Md Class 3 ·İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş.·1 device

Emboseal Non-Adhesive Embolization Agent (1cc)

Basic UDI-DI

EU MDD · Eu Md Class 3 ·İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş.·1 device