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)
Top companies in MWS
| Company | 510(k)s | Recalls |
|---|---|---|
| Maquet Cardiovascular, LLC | 0 | 8 |
| Medtronic Perfusion Systems | 0 | 4 |
| Terumo Cardiovascular Systems Corporation | 0 | 3 |
| Guidant Cardiac Surgery | 0 | 2 |
| Cardio Thoracic Systems | 1 | 0 |
| Cardiothoracic Systems, Inc. | 1 | 0 |
| Medtronic Vascular | 1 | 0 |
| Pilling Weck Surgical | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 24, 2026 | Medtronic Perfusion Systems Octopus 4 Tissue Stabilizer, Model 29400 Open, Classified |
MWS | None listed |
| Jun 24, 2026 | Medtronic Perfusion Systems Octopus Evolution AS Tissue Stabilizer, Model TS2500 Open, Classified |
MWS | None listed |
| Jun 24, 2026 | Medtronic Perfusion Systems Octopus Evolution Tissue Stabilizer, Model TS2000 Open, Classified |
MWS | None listed |
| Feb 26, 2026 | Medtronic Perfusion Systems Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1 Open, Classified |
MWS | None listed |
| Nov 18, 2024 | Maquet Cardiovascular, LLC Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z Open, Classified |
MWS | None listed |
| Nov 18, 2024 | Maquet Cardiovascular, LLC Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z Open, Classified |
MWS | None listed |
| Nov 18, 2024 | Maquet Cardiovascular, LLC Acrobat-i Positioner. Model Number C-XP-5000Z Open, Classified |
MWS | None listed |
| Dec 19, 2023 | Maquet Cardiovascular, LLC Acrobat-i Vacuum Positioner System, Model Number XP-5000Z Open, Classified |
MWS | None listed |
| Oct 22, 2023 | Maquet 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 |
MWS | None listed |
| Mar 2, 2021 | Terumo 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 |
MWS | None listed |
| Feb 22, 2017 | Terumo Cardiovascular Systems Corporation Titan" Stabilizer Attachment and Titan TM 360 Stabilizer
Attachment Terminated |
MWS | None listed |
| Feb 14, 2017 | Terumo Cardiovascular Systems Corporation Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel Terminated |
MWS | None listed |
| Oct 24, 2014 | Maquet 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 |
MWS | None listed |
| Feb 6, 2012 | Maquet 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 |
MWS | None listed |
| Feb 6, 2012 | Maquet 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 |
MWS | None listed |
| Mar 16, 2007 | Guidant Cardiac Surgery Guidant Acrobat Vacuum Stabilizer, Model number-OM-9100 Terminated |
MWS | None listed |
| Mar 16, 2007 | Guidant Cardiac Surgery Guidant Acrobat Vacuum Stabilizer, Model Number OM-9000. Terminated |
MWS | None listed |
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