ClearanceBrief
Panels › Cardiovascular › Product code MWS · Class 1

Stabilizer, Heart

Regulation 870.4500

0510(k)s in 12 months (4 all time)
4recalls in 12 months (17 all time)
0recalls that name a 510(k)
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Top companies in MWS

DateFirm and productCodeLinked 510(k)
Jun 24, 2026Medtronic Perfusion Systems
Octopus 4 Tissue Stabilizer, Model 29400
Open, Classified
MWSNone listed
Jun 24, 2026Medtronic Perfusion Systems
Octopus Evolution AS Tissue Stabilizer, Model TS2500
Open, Classified
MWSNone listed
Jun 24, 2026Medtronic Perfusion Systems
Octopus Evolution Tissue Stabilizer, Model TS2000
Open, Classified
MWSNone listed
Feb 26, 2026Medtronic Perfusion Systems
Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
Open, Classified
MWSNone listed
Nov 18, 2024Maquet Cardiovascular, LLC
Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z
Open, Classified
MWSNone listed
Nov 18, 2024Maquet Cardiovascular, LLC
Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
Open, Classified
MWSNone listed
Nov 18, 2024Maquet Cardiovascular, LLC
Acrobat-i Positioner. Model Number C-XP-5000Z
Open, Classified
MWSNone listed
Dec 19, 2023Maquet Cardiovascular, LLC
Acrobat-i Vacuum Positioner System, Model Number XP-5000Z
Open, Classified
MWSNone listed
Oct 22, 2023Maquet Cardiovascular, LLC
Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product Code: OM-10000Z
Open, Classified
MWSNone listed
Mar 2, 2021Terumo Cardiovascular Systems Corporation
Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm with links, a handle for providing cable tension, and a mechanis
Terminated
MWSNone listed
Feb 22, 2017Terumo Cardiovascular Systems Corporation
Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment
Terminated
MWSNone listed
Feb 14, 2017Terumo Cardiovascular Systems Corporation
Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
Terminated
MWSNone listed
Oct 24, 2014Maquet Cardiovascular, LLC
Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S Axius Xpose 3 Access Device XP-3000 XPOSE 4 Access Device XP-4000 Acrobat V Vacuum Off-Pump System Each Acroba
Terminated
MWSNone listed
Feb 6, 2012Maquet Cardiovascular, LLC
XPOSE 4 Access Device (XP-4000) XPOSE 3 Access Device (XP-3000) positioners. Product Usage: The OM-9100S Acrobat V Vacuum Off-Pump System is intended for use during performance of cardiac surgical pr
Terminated
MWSNone listed
Feb 6, 2012Maquet Cardiovascular, LLC
ACROBAT Stabilizers- ACROBAT V Vacuum Off-Pump System (OM-91 OOS), ACROBAT SUV Vacuum Off-Pump System (OM-9000S), ACROBAT Mechanical Off-Pump System (OM-6000S) Product Usage: The OM-9100S Acrobat V V
Terminated
MWSNone listed
Mar 16, 2007Guidant Cardiac Surgery
Guidant Acrobat Vacuum Stabilizer, Model number-OM-9100
Terminated
MWSNone listed
Mar 16, 2007Guidant Cardiac Surgery
Guidant Acrobat Vacuum Stabilizer, Model Number OM-9000.
Terminated
MWSNone listed

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