# Hemostasis, LLC

- Location (FDA's records): St. Paul, MN
- FDA decisions: 10 (2007–2024): 10 510(k) clearances
- Product codes: QSY (5), QAU (1), NHB (1), MTJ (1), LYA (1), EMX (1)
- Predicates its devices cite: 23 (6 its own); citations of its devices by later devices: 14 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medafor, Inc.: 4 (https://510kreport.com/company/medafor)
- Orthocon, Inc.: 2 (https://510kreport.com/company/orthocon)
- Endoclot Plus Co., Ltd.: 1 (https://510kreport.com/company/endoclot-plus)
- Polyganics B.V.,: 1 (https://510kreport.com/company/polyganics)
- Skeletal Kinetics, LLC: 1 (https://510kreport.com/company/skeletal-kinetics)
- Synthes (Usa) Products, LLC/Norian Corporation: 1 (https://510kreport.com/company/synthes-usa-products-norian)
- Hemcon, Inc.: 1 (https://510kreport.com/company/hemcon)
- Hem Con Medical Technologies, Inc.: 1 (https://510kreport.com/company/hem-con-medical-technologies)

## Firms that cite its devices most
- Catalina, Inc.: 1 (https://510kreport.com/company/catalina)
- Medtronic, Inc.: 1 (https://510kreport.com/company/medtronic)
- Emergency Medical Devices, LLC: 1 (https://510kreport.com/company/emergency-medical-devices)
- Polyganics B.V.,: 1 (https://510kreport.com/company/polyganics)
- Hem Con Medical Technologies, Inc.: 1 (https://510kreport.com/company/hem-con-medical-technologies)
- Gyrus Acmi, Inc.: 1 (https://510kreport.com/company/gyrus-acmi)
- Cryolife, Inc.: 1 (https://510kreport.com/company/cryolife)
- Coag Medical, LLC: 1 (https://510kreport.com/company/coag-medical)

## Its most-cited devices
- K070211: Traumarrest and Bleedarrest Hemostatic Particles and Foam (2007), cited by 5
- K102459: Nexstat (TM) Topical Hemostat Powder; Nexfoam (R) Topical Sponge (2010), cited by 3
- K120958: Posisep and Posisep X Hemostat Dressings (2012), cited by 2
- K072900: Excelarrest  Foam (2007), cited by 2
- K122494: Posisep and Posisep X Hemostat Dressing/Intranasal Splint (2013), cited by 2

## Recent decisions
- K234131: Resolv Endoscopic Hemostat System (Jul 26, 2024)
- K220326: PosiSep X BAM Hemostat Dressing/Intranasal Splint (Nov 14, 2022)
- K210411: PosiSep EAR Fragmentable Ear Dressing (May 5, 2022)
- K142348: OsteoSeal Bone Hemostat (Jan 23, 2015)
- K122494: Posisep and Posisep X Hemostat Dressing/Intranasal Splint (Mar 27, 2013)
- K122886: Nexstat Plus and Nexfoam Plus Topical Hemostat Dressing (Nov 15, 2012)
- K120958: Posisep and Posisep X Hemostat Dressings (Jul 25, 2012)
- K102459: Nexstat (TM) Topical Hemostat Powder; Nexfoam (R) Topical Sponge (Dec 3, 2010)

Source page: https://510kreport.com/company/hemostasis