Medical Device Manufacturer · US , St. Paul , MN

Hemostasis, LLC

10 submissions · 10 cleared · Since 2007
10
Total
10
Cleared
0
Denied

Hemostasis, LLC — FDA 510(k) Submissions

Hemostasis, LLC has submitted 10 FDA 510(k) premarket notifications since 2007, of which 10 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Hemostatic Wound Dressing Without Thrombin Or Other Biologics, Splint, Intranasal Septal, Wax, Bone, Polymer, Ear, Nose And Throat, Synthetic, Absorbable, Balloon, Epistaxis . Use the specialty filter in the sidebar to narrow results.

10 devices
1–10 of 10
Resolv Endoscopic Hemostat System
K234131 · QAU Hemostatic Device For... · General & Plastic Surgery
Jul 2024 211d
PosiSep X BAM Hemostat Dressing/Intranasal Splint
K220326 · EMX Balloon, Epistaxis · Ear, Nose, Throat
Nov 2022 283d
PosiSep EAR Fragmentable Ear Dressing
K210411 · NHB Polymer, Ear, Nose And... · Ear, Nose, Throat
May 2022 448d
OsteoSeal Bone Hemostat
K142348 · MTJ Wax, Bone · General & Plastic Surgery
Jan 2015 154d
POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT
K122494 · LYA Splint, Intranasal Septal · Ear, Nose, Throat
Mar 2013 223d
NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING
K122886 · QSY Hemostatic Wound Dressing... · General & Plastic Surgery
Nov 2012 56d
POSISEP AND POSISEP X HEMOSTAT DRESSINGS
K120958 · QSY Hemostatic Wound Dressing... · General & Plastic Surgery
Jul 2012 117d
NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGE
K102459 · QSY Hemostatic Wound Dressing... · General & Plastic Surgery
Dec 2010 98d
EXCELARREST FOAM
K072900 · QSY Hemostatic Wound Dressing... · General & Plastic Surgery
Oct 2007 15d
TRAUMARREST AND BLEEDARREST HEMOSTATIC PARTICLES AND FOAM
K070211 · QSY Hemostatic Wound Dressing... · General & Plastic Surgery
Apr 2007 73d
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