FDA 510(k) Applications for Medical Device Product Code "QSY"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K021062 | ABBOTT VASCULAR INC. | CHITO-SEAL | 08/23/2002 |
| K172324 | Advamedica Inc. | Axiostat Chitosan Hemostatic Dressing | 02/23/2018 |
| K202830 | Advamedica Inc. | Axiostat Patch | 04/15/2021 |
| K010933 | ALLTRACEL PHARMA LTD. | SEAL-ON TOPICAL HEMPSTATIC POWDER SPRAY | 01/08/2002 |
| K103245 | BAXTER HEALTHCARE CORP. | CELSTAT | 03/23/2011 |
| K142363 | Beeken Biomedical | NUSTAT, NUSTAT XR | 01/09/2015 |
| K160578 | Beeken Biomedical, LLC | Nustat XR | 06/29/2016 |
| K143462 | BENQ MATERIALS CORPORATION | AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use) | 05/08/2015 |
| K150963 | BENQ MATERIALS CORPORATION | AnsCare ChitoClot Pad | 11/05/2015 |
| K070520 | BIOLIFE, LLC | PRO QR (QUICK RELIEF) POWDER (FOR MINOR EXTERNAL BLEEDING FROM WOUNDS & PROCEDURES) | 10/23/2007 |
| K080210 | BIOLIFE, LLC | PRO QR ADVANCED FORMULA POWDER | 02/10/2009 |
| K130324 | BIOLIFE, LLC | STATSEAL DISC | 07/09/2013 |
| K101097 | BZ MEDICAL INC | CALGAESEAL MODEL: CAS | 09/22/2010 |
| K102742 | CATALINA, INC. | NASAL CEASE | 02/02/2011 |
| K112864 | CHITOGEN, INC. | SOFTSEAL-C | 08/02/2012 |
| K090100 | CHITOGEN, INC. | SOFTSEAL-STF | 03/11/2009 |
| K140313 | COAG MEDICAL LLC | STOPSBLEEDING TOPICAL HEMOSTAT POWDER AND FOAM | 07/28/2014 |
| K160679 | CORE SCIENTIFIC CREATION LTD. | WoundClot9 | 08/08/2016 |
| K140573 | CORE SCIENTIFIC LTD. | WOUNDCLOT HEMOSTATIC GAUZE | 11/24/2014 |
| K102944 | CORELEADER BIOTECH CO., LTD. | CORELEADER HEMO-PAD MODEL CPII 02030 | 09/07/2011 |
| K151204 | CORELEADER BIOTECH CO., LTD. | HEMO-Bandage | 07/31/2015 |
| K061722 | CROSSLINK-D, INC | BLOXX RAPID CLOTTING AGENT | 08/02/2006 |
| K082601 | EMERGENCY MEDICAL DEVICES, LLC | UltraClot, UltraClot OTC | 10/09/2008 |
| K072890 | ENTEGRION, INC. | STASILON FR | 12/10/2007 |
| K040283 | EURORESEARCH S.R.L. | BIOPAD | 07/22/2005 |
| K091194 | EVOLUTION MEDICAL TECHNOLOGIES LLC | ALGISEAL PAD | 05/18/2009 |
| K180152 | gel-e, Inc. | gel-e Flex | 06/22/2018 |
| K182811 | gel-e, Inc. | gel-e Flex+ | 08/29/2019 |
| K192667 | gel-e, Inc. | gel-e Flex+ gel OTC | 10/25/2019 |
| K211570 | Hangzhou Zeo-Innov Life Technology Co., Ltd. | Zeolite Hemostatic Gauze | 02/10/2022 |
| K093729 | HEMCON MEDICAL TECHNOLOGIES EUROPE LTD | GUARDIVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 IN/ 4MM, STERILE, GUARD IVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 I | 06/08/2010 |
| K121485 | HEMCON MEDICAL TECHNOLOGIES EUROPE LTD | GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING | 08/21/2012 |
| K112215 | HEMCON MEDICAL TECHNOLOGIES EUROPE, LTD. | HEMCON HEMOSTATIC GEL | 04/12/2012 |
| K102546 | HEMCON MEDICAL TECHNOLOGIES, INC. | CHITOGAUZE | 11/17/2010 |
| K111163 | HEMCON MEDICAL TECHNOLOGIES, INC. | CHITOGAUZE FUSION | 05/17/2011 |
| K090026 | HEMCON MEDICAL TECHNOLOGIES, INC. | CHITOGAUZE, MODELS 130, 131, 263, 264, 265, 266 | 03/31/2009 |
| K092357 | HEMCON MEDICAL TECHNOLOGIES, INC. | 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 | 08/25/2009 |
| K103641 | HEMCON MEDICAL TECHNOLOGIES, INC. | GUARDACARE | 06/16/2011 |
| K150916 | HemCon Medical Technologies, Inc. | HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO | 11/10/2015 |
| K080818 | HEMCON MEDICAL TECHNOLOGIES, INC. | HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING | 05/15/2008 |
| K072486 | HEMCON MEDICAL TECHNOLOGIES, INC. | MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC | 08/06/2008 |
| K153582 | HEMCON MEDICAL TECHNOLOGIES, INC. | Prometheus ChitoGauze XR PRO | 05/25/2016 |
| K023298 | HEMCON, INC. | HEMCON BANDAGE | 11/04/2002 |
| K043050 | HEMCON, INC. | HEMCON BANDAGE AND HEMCON BANDAGE OTC | 06/03/2005 |
| K030946 | HEMCON, INC. | HEMCON BANDAGE OTC; HEMCON CATH/AID | 06/19/2003 |
| K071519 | HEMCON, INC. | HEMCON CHITOFLEX-SURGICAL DRESSING | 08/06/2007 |
| K965034 | HEMOSTACE LLC. | SORBASTACE | 04/09/1998 |
| K072900 | HEMOSTASIS, LLC | EXCELARREST FOAM | 10/26/2007 |
| K102459 | HEMOSTASIS, LLC | NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGE | 12/03/2010 |
| K122886 | HEMOSTASIS, LLC | NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING | 11/15/2012 |
| K120958 | HEMOSTASIS, LLC | POSISEP AND POSISEP X HEMOSTAT DRESSINGS | 07/25/2012 |
| K070211 | HEMOSTASIS, LLC | TRAUMARREST AND BLEEDARREST HEMOSTATIC PARTICLES AND FOAM | 04/05/2007 |
| K112800 | HUIZHOU FORYOU MEDICAL DEVICES CO, LTD | SUNTOUCH TOPICAL HEMOSTATIC DRESSING | 05/23/2012 |
| K161013 | InnoTherapy Inc. | InnoSEAL Hemostatic Pad | 11/29/2016 |
| K982638 | INNOVATIVE TECHNOLOGIES LTD. | 3M TEGAGEN HI ALGINATE DRESSING & 3 M TEGAGEN HG ALGINATE DRESSING, MODEL #'S 90110,90112,90114,90120, 90210,90212,90214 | 08/21/1998 |
| K183622 | Les Laboratoires Brothier S.A. | NasalCEASE and BleedCEASE | 12/02/2019 |
| K071578 | LIFESCIENCE PLUS, INC. | BLOODSTOP AND BLOODSTOP IX HEMOSTATIC GAUZE, MODELS BS-10,BS-11,BS-12,B-13, BS-IX27, BS-IX-14, BSIX-15, BSIX-17 | 09/27/2007 |
| K072681 | LIFESCIENCE PLUS, INC. | BLOODSTOP HEMOSTATIC GAUZE; IX HEMOSTATIC GAUZE | 11/02/2007 |
| K160130 | LifeSciencePLUS Inc. | BloodSTOP iX Battle Matrix | 06/29/2016 |
| K033666 | MEDAFOR, INC. | HEMADERM | 12/17/2003 |
| K021678 | MEDAFOR, INC. | HEMADERM COTAINING HEMADEX CLOTTING BEADS | 07/12/2002 |
| K190012 | Medtrade Product Ltd | OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid | 12/18/2019 |
| K093593 | MEDTRADE PRODUCTS LIMITED | CELOX PRO, CELOX PRO OTC, CELOX HEMOSTATIC GRANULES, CELOX PRO HEMOSTATIC GRANULES, OMNI STAT PRO | 01/20/2010 |
| K070175 | MEDTRADE PRODUCTS LTD. | AQUANOVA SUPER-ABSORBENT GELLING DRESSING, OTC | 07/25/2007 |
| K132333 | MEDTRADE PRODUCTS LTD. | BONDILOXS TOPICAL HEMOSTATIC DRESSING | 06/25/2014 |
| K161274 | MEDTRADE PRODUCTS LTD. | Bondiloxs Topical Hemostatic Granules | 01/18/2017 |
| K113560 | MEDTRADE PRODUCTS LTD. | CELOX GAUZE PRO | 08/01/2012 |
| K110386 | MEDTRADE PRODUCTS LTD. | CELOX RAPID GAUZE | 05/10/2011 |
| K102965 | MEDTRADE PRODUCTS LTD. | CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TRAUMA GAUZE AG, OMNI-STAT HEMOSTATIC ANTI | 12/08/2010 |
| K080097 | MEDTRADE PRODUCTS LTD. | MEDTRADE PRODUCTS CELOX HEMOSTATIC GRANULES ON SHEET | 07/09/2008 |
| K072328 | MEDTRADE PRODUCTS LTD. | MEDTRADE PRODUCTS CELOX SOLBAG, ANTI - COAGULANT | 12/21/2007 |
| K061079 | MEDTRADE PRODUCTS LTD. | MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC GRANULES, MEDTRADE PRODUCTS CELOX 762 HEMOSTATIC GRANULES | 06/02/2006 |
| K090780 | MEDTRADE PRODUCTS LTD. | MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC PASTE | 11/20/2009 |
| K091795 | MEDTRADE PRODUCTS LTD. | MEDTRADE PRODUCTS CELOX TRAUMA GAUZE | 11/20/2009 |
| K093519 | MEDTRADE PRODUCTS LTD. | MEDTRADE PRODUCTS CELOX VASCULAR TOPICAL HEMOSTATIC GRANULES ON SHEET | 01/14/2010 |
| K101257 | NANOSYS, INC. | ADVANCED TRAUMA DRESSING (ATD) | 12/01/2011 |
| K063190 | NOBLE FIBER TECHNOLOGIES, INC. | SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC | 08/21/2007 |
| K021581 | ON SITE GAS SYSTEMS, INC. | HEMOSORB | 07/12/2002 |
| K013390 | ON SITE GAS SYSTEMS, INC. | QUICKCLOT | 05/23/2002 |
| K080648 | ORE-MEDIX, LLC | TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE | 05/07/2008 |
| K180893 | Protege Biomedical | IHM Technology Bandage | 09/19/2018 |
| K033291 | RADI MEDICAL SYSTEMS AB | TOPSEAL HEMOSTATIC DRESSING, MODEL 11150 | 03/17/2004 |
| K143466 | REMEDIUM TECHNOLOGIES, INC. | Hemogrip Patch | 06/08/2015 |
| K133121 | SAM MEDICAL PRODUCTS | CHITO-SAM 100,4IN X4IN,CHITO-SAM, 3IN X6FT, CHITO-SAM 100,3IN X10FT, CHITO-SAM ACTIVE, 4INX4IN,CHITO-SAM ACTIVE, 3INX6FT | 05/22/2014 |
| K112961 | SCION CARDIO-VASCULAR, INC. | CLO-SURPLUS P.A.D. | 10/31/2011 |
| K092552 | SCION CARDIO-VASCULAR, INC. | CLO-SURPLUS P.A.D. | 09/04/2009 |
| K032986 | SCION CARDIO-VASCULAR, INC. | CLO-SURPLUSP.A.D. | 03/01/2004 |
| K192671 | Solaplus Biotech Co., Ltd. | Hemostatic Xerogel Sponge | 08/28/2020 |
| K172155 | StatGuard, LLC | StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing | 04/12/2018 |
| K030334 | T-SCIENTIFIC, INC. | T-SCIENTIFIC T-PAD | 04/21/2003 |
| K081183 | TRAUMACURE INC. | WOUNDSTAT | 06/19/2008 |
| K071936 | TRAUMACURE INC. | WOUNDSTAT, MODEL TC1001 | 08/23/2007 |
| K040208 | TZ MEDICAL, INC. | NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND | 05/11/2004 |
| K080532 | UNICARE BIOMEDICAL, INC. | BENACEL, MODELS C-001, C-002 AND C-005 | 11/12/2008 |
| K060409 | VANSON-HALOSOURCE, INC. | HEMOHALT HEMOSTASIS PAD | 05/17/2006 |
| K120782 | Z-MEDICA CORPORATION | INTERVENTIONAL HEMOSTATIC BANDAGE | 03/20/2013 |
| K051955 | Z-MEDICA CORPORATION | QUICKCLOT ACS - ACCELERATED CLOTTING SPONGE | 08/10/2005 |
| K061767 | Z-MEDICA CORPORATION | QUIKCLOT 1ST RESPONSE & QUIKCLOT ACS+ | 07/19/2006 |
| K050769 | Z-MEDICA CORPORATION | QUIKCLOT BRAND HEMOSTATIC AGENT - ADVANCED BEADED FORMULATION - 100G - 1.9MM - 2.4MM., MODEL 100172 | 04/14/2005 |
| K072474 | Z-MEDICA CORPORATION | QUIKCLOT EX | 10/16/2007 |
| K090620 | Z-MEDICA CORPORATION | QUIKCLOT INTEVENTIONAL, MODEL P/N 182 | 04/08/2009 |
| K070010 | Z-MEDICA CORPORATION | QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER | 01/25/2007 |
| K140757 | Z-MEDICA, LLC | D2 HEMOSTANTIC DRESSING | 07/17/2014 |
| K123387 | Z-MEDICA, LLC | QUIKCLOT HEMOSTATIC DRESSING | 04/12/2013 |
| K181641 | Z-Medica, LLC | QuikClot Radial | 12/24/2018 |
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