28 results · 43ms · Sources: EU EUDAMED, US FDA

HawkOne Directional Atherectomy System

FDA registration
Medtronic, Inc.·1 product·🇺🇸 United States

Synergy Health Westport Ltd

FDA registration
Synergy Health Westport Ltd·1 product·🇮🇪 Ireland

HawkOne HawkOne™ Directional Atherectomy System Intraluminal artery stripper

FDA registration
MEDTRONIC IRELAND·1 product·🇮🇪 Ireland

HawkOne HawkOne™ Directional Atherectomy System Intraluminal artery stripper

FDA registration
Medtronic, Inc.·1 product·🇺🇸 United States

Sterigenics US LLC

FDA registration
Sterigenics US LLC·1 product·🇺🇸 United States

Synergy Health Ireland Ltd

FDA registration
Synergy Health Ireland Ltd·1 product·🇮🇪 Ireland

Isomedix Operations, Inc.

FDA registration
Isomedix Operations, Inc.·1 product·🇺🇸 United States

HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

Catheter, Peripheral, Atherectomy

FDA classification
FDA Class 2 ·Catheter, Peripheral, Atherectomy

3M™ Unitek™

FDA UDI
3M UNITEK CORPORATION·00652221037985·Unitek(TM) Bicuspid Band General Purpose Wide L...

TOMZ Corporation

FDA registration
TOMZ Corporation·5 products·🇺🇸 United States

Viper System

FDA registration
Jabil Switzerland Manufacturing GmbH (Le Locle)·5 products·🇨🇭 Switzerland

EXPEDIUM MIS SPINE SYSTEM

FDA registration
EXEL INC. DBA DHL SUPPLY CHAIN (USA)·5 products·🇺🇸 United States

SJF

FDA registration
HOOSIER, INC.·1 product·🇺🇸 United States

Viper System

FDA registration
SYNTHES GMBH·5 products·🇨🇭 Switzerland

Viper System

FDA registration
MEDOS INTERNATIONAL SARL·5 products·🇨🇭 Switzerland

Simmetry Indication Change

FDA registration
SIVANTAGE, INC.·1 product·🇺🇸 United States

Metal Craft Machine & Engineering, Inc.

FDA registration
Metal Craft Machine & Engineering, Inc.·1 product·🇺🇸 United States

Viper System

FDA registration
Synthes GMBH·5 products·🇨🇭 Switzerland

Viper System

FDA registration
DEPUY SPINE, INC.·5 products·🇺🇸 United States