510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QSYUnclassified

Hemostatic Wound Dressing Without Thrombin Or Other Biologics

Unknown
FDA source (opens on fda.gov)

QSY is the FDA product code for Hemostatic Wound Dressing Without Thrombin Or Other Biologics. FDA's definition for this code reads: "To temporarily control bleeding and cover external wounds". As of , FDA records hold 127 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QSY
Device name
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
FDA definition
To temporarily control bleeding and cover external wounds.
Device class
Unclassified
Review panel
Unknown
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
127
Ingested recalls
0

Clearances, product code QSY

By decision year
127 clearances under product code QSY with a decision year between 1990 and 2026, 2007 the highest year at 13.
Show the numbers
510(k) clearances under FDA product code QSY by decision year
YearClearances
19902
19913
19982
20026
20033
20043
20054
20064
200713
20087
20099
20107
20118
20127
20133
20146
20156
20165
20171
20185
20194
20201
20211
20222
20237
20244
20252
20262

Applicants with the most clearances

Product code QSY
Applicants holding the most 510(k) clearances under product code QSY
ApplicantClearances
Medtrade Products Ltd.14
Z-Medica, LLC10
Hem Con Medical Technologies, Inc.9
Hemostasis, LLC5
Hemcon, Inc.4
Lifescience Plus, Inc.4
Advamedica Inc.3
Biolife, LLC3
Calgon Vestal Div.3
Cresilon Inc3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 104 companies shown, in name order