K000011

FDA registration

Lake Region Medical·1 product·🇺🇸 United States

Brasseler USA

FDA UDI

Peter Brasseler Holdings, LLC·00887919498858·K000011 SOLUTION ORTHO KIT 1P

H20 Guidewire

FDA registration

Merit Medical Nederland BV·1 product·🇳🇱 Netherlands

Medtronic2686 (MN) - AqWire Hydrophilic Guidewire

FDA registration

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

H20 Guidewire

FDA registration

Merit Medical Canada Ltd.·1 product·🇨🇦 Canada

H20 Guidewire

FDA registration

Merit Medical UK Limited·1 product·🇬🇧 United Kingdom

HydroSteer

FDA registration

Abbott Vascular Netherlands·1 product·🇳🇱 Netherlands

H20 Guidewire (Lake Region)

FDA registration

Sterigenics U.S., LLC·1 product·🇺🇸 United States

HydroSteer

FDA registration

St. Jude Medical, Cardiology Division, Inc.·1 product·🇺🇸 United States

H20 Guidewire

FDA registration

Merit Medical Australia Pty Ltd.·1 product·🇦🇺 Australia

AqWire Hydrophilic Guidewire

FDA registration

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

H20 Guidewire

FDA registration

MERIT MEDICAL SYSTEMS, INC.·1 product·🇺🇸 United States

Wire, Guide, Catheter ZIPwire

FDA registration

Venusa de Mexico S. de R.L de C.V·1 product·🇲🇽 Mexico

H20 Guidewire (Lake Region)

FDA registration

Sterigenics U.S., LLC·1 product·🇺🇸 United States

HydroSteer

FDA registration

St. Jude Medical, Atrial Fibrillation Division, Inc.·1 product·🇺🇸 United States

MODIFIED HYDROPHILIC COATED GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

N/A

FDA UDI

MEDTRONIC SOFAMOR DANEK, INC.·00613994989802·DRILL 2000011 CANNULATED 7MM

Medtronic Reusable Instruments

FDA UDI

MEDTRONIC SOFAMOR DANEK, INC.·00643169056091·CAM SPREADER TRIAL 4000011 6 DEG 11MM

PIVO 22G

FDA UDI

VELANO VASCULAR, INC.·00850984007010·PIVO 22G Compatible device

Impression Tray XSM

FDA UDI

Access Dental Lab, LLC·00850007728366·Impression Tray Extra Small