Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·Arctic Front Cardiac CryoAblation System: Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoabl

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Epic, Epic Supra, Epic Plus, Epic Plus Supra, Epic Max, Portico, Navitor, and Navitor Titan Tissue Heart Valves

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Epic, Epic Supra, Epic Plus, Epic Plus Supra, Epic Max, Portico, Navitor, and Navitor Titan Tissue Heart Valves

KAB Import GmbH

Importer

🇦🇹 Austria

381008

Certificate

MDD Annex V·KAZ Europe Sàrl·DQS Medizinprodukte GmbH·2 Basic UDI-DIs

Medical Monitor

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Xuzhou AKX Electronic Science and Technology co.，Ltd·1 device

Digital Electronic Colposcope

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Xuzhou AKX Electronic Science and Technology co.，Ltd·2 devices

Endoscope Camera (FULL HD Endoscope System; 4K Medical Endoscope Camera System)

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Xuzhou AKX Electronic Science and Technology co.，Ltd·13 devices

Sterrad

FDA UDI

ADVANCED STERILIZATION PRODUCTS SERVICES INC.·10705037016532·Sterrad 50/100S Sterilizer Cyclesure 24 Validat...

Sterrad

FDA UDI

ADVANCED STERILIZATION PRODUCTS SERVICES INC.·10705037016594·Sterrad NX Validation Kit

Wax, Bone

FDA classification

FDA Unclassified ·Wax, Bone

IMMAGE Immunochemistry Systems KAP Kappa Light Chain Reagent

Basic UDI-DI

EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·1 device

Kai Europe GmbH

Authorized representative

🇩🇪 Germany·1 Manufacturer·6 Devices

HZ 2066395-1

Certificate

MDR QMS·Kai Industries Co., Ltd.·TÜV Rheinland LGA Products GmbH

ENT POCKET LIGHT

FDA UDI

C F M TECHNOLOGIES INC·00850013958030·Deluxe ENT Pocket Light Set Otoscope set with ...

ENT POCKET LIGHT

FDA UDI

C F M TECHNOLOGIES INC·00850013958023·Deluxe ENT Pocket Light Set Otoscope set with ...

FAX INTERNATIONAL OPHTALMICS INSTRUMENTS

Importer

🇫🇷 France·10 Manufacturers

GRZEGORZ NOWAK HAXE POLSKA

Importer

🇵🇱 Poland

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ENPULSE E1 IPG, ENPULSE E2 IPG,KAPPA D (KAPPA 700) IPG, KAP

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA,VERSA,SENSIA IPG,ADVISA DR IPG,ADVISA DR MRI IPG,AT500 DDDRP PACING SYSTEM IPG, ENPULSE E2 IPG,ENPULSE E2 IPG,KAP