Hemostatic Wound Dressing Without Thrombin Or Other Biologics
FDA product code QSY · 115 cleared devices
Class U
Unknown
- Review panel
- SU
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1990-02-13 – 2026-04-30
To temporarily control bleeding and cover external wounds.
QSY
2026-04-30
QSY
2026-02-26
Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (FG100600); Ganymede 20cm x 30cm (FG100700); Ganymede 25cm x 25cm (FG100800); Ganymede 30cm x 30cm (FG100900); Ganymede 40cm x 40cm (FG100999); Ganymede 7.5cm x 120cm (FG100100); Ganymede-X 2cm diameter (FG100301); Ganymede-X 5cm x 5cm (FG100401); Ganymede-X 10cm x 10cm (FG100501); Ganymede-X 15cm x 15cm (FG100601); Ganymede-X 20cm x 30cm (FG100701); Ganymede-X 25cm
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QSY
2025-12-15
MFUSE (MS001)
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QSY
2025-12-12
TRAUMAGEL® 2.0 Hemostatic Gel
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QSY
2024-08-14
TRAUMAGEL®
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QSY
2024-05-22
Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)
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QSY
2024-04-19
Hemoblock_S (Prescription); Hemoblock_S (OTC)
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QSY
2024-03-15
RESPONDER® Polysaccharide Hemostat
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QSY
2023-12-04
RESPONDER Polysaccharide Hemostat
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QSY
2023-11-17
Celox Rapid X-Ray Gauze
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QSY
2023-09-01
Hemostatic Dressing
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QSY
2023-06-28
Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)
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QSY
2023-05-02
Zeolite Hemostatic Cotton
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QSY
2023-04-07
Axiostat Gauze
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QSY
2023-02-02
S.E.A.L. Hemostatic Wound Spray
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QSY
2022-07-29
Vascette HP (hemostatic pad)
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QSY
2022-02-10
Zeolite Hemostatic Gauze
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QSY
2021-04-15
Axiostat Patch
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QSY
2020-08-28
Hemostatic Xerogel Sponge
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QSY
2019-12-18
OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid
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QSY
2019-12-02
NasalCEASE and BleedCEASE
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QSY
2019-10-25
gel-e Flex+ gel OTC
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QSY
2019-08-29
gel-e Flex+
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QSY
2018-12-24
QuikClot Radial
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QSY
2018-09-19
IHM Technology Bandage
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QSY
2018-06-22
gel-e Flex
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QSY
2018-04-12
StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing
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QSY
2018-02-23
Axiostat Chitosan Hemostatic Dressing
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QSY
2017-01-18
Bondiloxs Topical Hemostatic Granules
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QSY
2016-11-29
InnoSEAL Hemostatic Pad
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QSY
2016-08-08
WoundClot9
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QSY
2016-06-29
Nustat XR
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QSY
2016-06-29
BloodSTOP iX Battle Matrix
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QSY
2016-05-25
Prometheus ChitoGauze XR PRO
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QSY
2013-07-09
STATSEAL DISC
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QSY
2013-04-12
QUIKCLOT HEMOSTATIC DRESSING
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QSY
2013-03-20
INTERVENTIONAL HEMOSTATIC BANDAGE
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QSY
2012-11-15
NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING
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QSY
2012-08-21
GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING
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QSY
2012-08-02
SOFTSEAL-C
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QSY
2012-08-01
CELOX GAUZE PRO
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QSY
2012-07-25
POSISEP AND POSISEP X HEMOSTAT DRESSINGS
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QSY
2012-05-23
SUNTOUCH TOPICAL HEMOSTATIC DRESSING
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QSY
2012-04-12
HEMCON HEMOSTATIC GEL
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QSY
2011-12-01
ADVANCED TRAUMA DRESSING (ATD)
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QSY
2011-10-31
CLO-SURPLUS P.A.D.
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QSY
2011-09-07
CORELEADER HEMO-PAD MODEL CPII 02030
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QSY
2011-06-16
GUARDACARE
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QSY
2011-05-17
CHITOGAUZE FUSION
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QSY
2011-05-10
CELOX RAPID GAUZE
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QSY
2011-03-23
CELSTAT
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QSY
2011-02-02
NASAL CEASE
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QSY
2010-12-08
CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TRAUMA GAUZE AG, OMNI-STAT HEMOSTATIC ANTI
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QSY
2010-12-03
NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGE
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QSY
2010-11-17
CHITOGAUZE
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QSY
2010-09-22
CALGAESEAL MODEL: CAS
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QSY
2010-06-08
GUARDIVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 IN/ 4MM, STERILE, GUARD IVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 I
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QSY
2010-01-20
CELOX PRO, CELOX PRO OTC, CELOX HEMOSTATIC GRANULES, CELOX PRO HEMOSTATIC GRANULES, OMNI STAT PRO
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QSY
2010-01-14
MEDTRADE PRODUCTS CELOX VASCULAR TOPICAL HEMOSTATIC GRANULES ON SHEET
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QSY
2009-11-20
MEDTRADE PRODUCTS CELOX TRAUMA GAUZE
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QSY
2009-11-20
MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC PASTE
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QSY
2009-09-04
CLO-SURPLUS P.A.D.
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QSY
2009-08-25
CHITOGAUZE,2 IN X 2 IN,8 PLY, 4 IN X 4 IN 8 PLY, 4 IN X 8 IN, 8PLY, 1 IN X 4 IN, 8PLY, CHITOGAUZE, PACKAGING STRIP, 1/2
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QSY
2009-05-18
ALGISEAL PAD
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QSY
2009-04-08
QUIKCLOT INTEVENTIONAL, MODEL P/N 182
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QSY
2009-03-31
CHITOGAUZE, MODELS 130, 131, 263, 264, 265, 266
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QSY
2009-03-11
SOFTSEAL-STF
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QSY
2009-02-10
PRO QR ADVANCED FORMULA POWDER
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QSY
2008-11-12
BENACEL, MODELS C-001, C-002 AND C-005
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QSY
2008-10-09
UltraClot, UltraClot OTC
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QSY
2008-08-06
MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC
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QSY
2008-07-09
MEDTRADE PRODUCTS CELOX HEMOSTATIC GRANULES ON SHEET
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QSY
2008-06-19
WOUNDSTAT
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QSY
2008-05-15
HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING
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QSY
2008-05-07
TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE
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QSY
2007-12-21
MEDTRADE PRODUCTS CELOX SOLBAG, ANTI - COAGULANT
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QSY
2007-12-10
STASILON FR
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QSY
2007-11-02
BLOODSTOP HEMOSTATIC GAUZE; IX HEMOSTATIC GAUZE
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QSY
2007-10-26
EXCELARREST FOAM
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QSY
2007-10-23
PRO QR (QUICK RELIEF) POWDER (FOR MINOR EXTERNAL BLEEDING FROM WOUNDS & PROCEDURES)
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QSY
2007-10-16
QUIKCLOT EX
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QSY
2007-09-27
BLOODSTOP AND BLOODSTOP IX HEMOSTATIC GAUZE, MODELS BS-10,BS-11,BS-12,B-13, BS-IX27, BS-IX-14, BSIX-15, BSIX-17
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QSY
2007-08-23
WOUNDSTAT, MODEL TC1001
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QSY
2007-08-21
SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC
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QSY
2007-08-06
HEMCON CHITOFLEX-SURGICAL DRESSING
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QSY
2007-07-25
AQUANOVA SUPER-ABSORBENT GELLING DRESSING, OTC
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QSY
2007-04-05
TRAUMARREST AND BLEEDARREST HEMOSTATIC PARTICLES AND FOAM
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QSY
2007-01-25
QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER
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QSY
2006-08-02
BLOXX RAPID CLOTTING AGENT
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QSY
2006-07-19
QUIKCLOT 1ST RESPONSE & QUIKCLOT ACS+
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QSY
2006-06-02
MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC GRANULES, MEDTRADE PRODUCTS CELOX 762 HEMOSTATIC GRANULES
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QSY
2006-05-17
HEMOHALT HEMOSTASIS PAD
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QSY
2005-08-10
QUICKCLOT ACS - ACCELERATED CLOTTING SPONGE
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QSY
2005-07-22
BIOPAD
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QSY
2005-06-03
HEMCON BANDAGE AND HEMCON BANDAGE OTC
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QSY
2005-04-14
QUIKCLOT BRAND HEMOSTATIC AGENT - ADVANCED BEADED FORMULATION - 100G - 1.9MM - 2.4MM., MODEL 100172
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QSY
2004-05-11
NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND
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QSY
2004-03-17
TOPSEAL HEMOSTATIC DRESSING, MODEL 11150
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QSY
2004-03-01
CLO-SURPLUSP.A.D.
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QSY
2003-12-17
HEMADERM
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