PMA · Approved
Recalled · Class II · 2023Floseal Matrix/Floseal Matrix Hemostatic Sealant/Proceed Hemostatic Sealant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · PMX Absorbable Collagen Hemostatic Agent With Thrombin
Approved on Dec 8, 1999 through premarket approval, which rests on the device’s own clinical evidence after a 289-day review. It has been recalled 3 times.
- Decided
- Dec 8, 1999
- Review
- 289 days
- Class
- Class III
- Product code
- PMX
- Recalls
- 3
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P990009 has 74 supplements since 2000: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2000 | 1 |
| 2001 | 9 |
| 2002 | 2 |
| 2003 | 2 |
| 2005 | 2 |
| 2006 | 2 |
| 2007 | 3 |
| 2008 | 3 |
| 2009 | 1 |
| 2010 | 5 |
| 2011 | 2 |
| 2012 | 2 |
| 2013 | 3 |
| 2014 | 1 |
| 2015 | 3 |
| 2016 | 2 |
| 2017 | 6 |
| 2019 | 7 |
| 2020 | 7 |
| 2021 | 1 |
| 2022 | 3 |
| 2023 | 2 |
| 2024 | 2 |
| 2025 | 3 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PMX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 6, 2023 | Class II | Z-0667-2024 | Under Investigation by firm | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information… |
| May 30, 2018 | Class II | Z-2957-2018 | Mixed-up of materials/components | Baxter r recalled this device due to the use of an incorrect plastic formulation in the manufacture of the blue luer component of the FLOSEAL malleable tips. |
| Jul 31, 2008 | Not classified | Z-2340-2008 | Pending | The recall is being conducted as a precautionary measure due to potential discoloration of the FloSeal material noted in six (6) non-medical complaints during delivery by the Endoscopic Applicator. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All PMX devicesPMX Absorbable Collagen Hemostatic Agent With Thrombin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · PMX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PMX
Too few PMX 510(k)s in any year since 2007 to give a median.
Recalls per year · PMX
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PMX
5in 2025
MAUDE reports naming product code PMX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 8 | — | 0 | 0 |
| 2018 | 11 | — | 0 | 1 |
| 2019 | 16 | — | 0 | 2 |
| 2020 | 10 | — | 0 | 1 |
| 2021 | 5 | — | 0 | 2 |
| 2022 | 4 | — | 0 | 0 |
| 2023 | 1 | — | 1 | 5 |
| 2024 | 3 | — | 0 | 5 |
| 2025 | 4 | — | 0 | 5 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/P990009 · printed Nov 3, 2026
Cite this page
510(k) Report. “P990009: Floseal Matrix/Floseal Matrix Hemostatic Sealant/Proceed Hemostatic Sealant.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/P990009
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026