ClearanceBrief
Panels › Cardiovascular › Product code DWC · Class 2

Controller, Temperature, Cardiopulmonary Bypass

Regulation 870.4250

0510(k)s in 12 months (30 all time)
0recalls in 12 months (52 all time)
51recalls that name a 510(k)
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Top companies in DWC

Company510(k)sRecalls
Terumo Cardiovascular Systems Corp.115
Sorin Group USA, Inc.014
CardioQuip, LLC09
Daily Medical Products, Inc.50
LivaNova USA04
Cincinnati Sub-Zero Products, Inc.12
Livanova Deutschland, GmbH21
3M Health Care, Sarns20
Cincinnati Sub-Zero Products LLC, a Gentherm Company02
Gambro, Inc.20
DateFirm and productCodeLinked 510(k)
Jun 11, 2010Terumo Cardiovascular Systems Corporation
Terumo HX2 Temperature Management System 120V, 50/60 Hz catalog number 809810, Terumo Cardiovascular Systems Corp., Ann Arbor MI. The Terumo HX2 Temperature Management System provides temperature con
Terminated		 DWCK071521
Jan 25, 2007MAQUET Inc.
Jostra Heater Cooler Unit HCU30, system version 1.02-Low voltage machine
Terminated		 DWCK031544

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