Hemostasis, LLC
Saint Paul, MN, US
HEMOSTASIS, LLC appears in FDA device records in Saint Paul, MN. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Hemostasis, LLC between 2007 and 2024. The busiest year on record is 2007, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 2 |
| 2010 | 1 |
| 2012 | 2 |
| 2013 | 1 |
| 2015 | 1 |
| 2022 | 2 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K234131 | Resolv Endoscopic Hemostat System | QAU | Substantially Equivalent | |
| K220326 | PosiSep X BAM Hemostat Dressing/Intranasal Splint | EMX | Substantially Equivalent | |
| K210411 | PosiSep EAR Fragmentable Ear Dressing | NHB | Substantially Equivalent | |
| K142348 | OsteoSeal Bone Hemostat | MTJ | Substantially Equivalent | |
| K122494 | POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT | LYA | Substantially Equivalent | |
| K122886 | NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING | QSY | Substantially Equivalent | |
| K120958 | POSISEP AND POSISEP X HEMOSTAT DRESSINGS | QSY | Substantially Equivalent | |
| K102459 | NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGE | QSY | Substantially Equivalent | |
| K072900 | EXCELARREST FOAM | QSY | Substantially Equivalent | |
| K070211 | TRAUMARREST AND BLEEDARREST HEMOSTATIC PARTICLES AND FOAM | QSY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007225047 | 3007225047 | HEMOSTASIS, LLC | 5000 Township Pkwy, Saint Paul, MN 55110 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Hemostasis, LLC edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain