Product code QSY ยท Class U
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
4510(k)s in 12 months (127 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QSY
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtrade Products , Ltd. | 14 | 0 |
| Z-Medica Corporation | 10 | 0 |
| Hem Con Medical Technologies, Inc. | 9 | 0 |
| Hemostasis, LLC | 5 | 0 |
| Hemcon, Inc. | 4 | 0 |
| Lifescience Plus, Inc. | 4 | 0 |
| Advamedica, Inc. | 3 | 0 |
| Biolife, LLC | 3 | 0 |
| Calgon Vestal Div. | 3 | 0 |
| Cresilon, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 21, 2012 | K121485 | GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING Hemcon Medical Technologies Europe, Ltd. | QSY |
| Aug 2, 2012 | K112864 | SOFTSEAL-C Chitogen, Inc. | QSY |
| Aug 1, 2012 | K113560 | CELOX GAUZE PRO Medtrade Products , Ltd., GB | QSY |
| Jul 25, 2012 | K120958 | POSISEP AND POSISEP X HEMOSTAT DRESSINGS Hemostasis, LLC | QSY |
| May 23, 2012 | K112800 | SUNTOUCH TOPICAL HEMOSTATIC DRESSING Huizhou Foryou Medical Devices Co., Ltd. | QSY |
| Apr 12, 2012 | K112215 | HEMCON HEMOSTATIC GEL Hemcon Medical Technologies Europe, Ltd. | QSY |
| Dec 1, 2011 | K101257 | ADVANCED TRAUMA DRESSING (ATD) Nanosys, Inc. | QSY |
| Oct 31, 2011 | K112961 | CLO-SURPLUS P.A.D. Scion Cardio-Vascular, Inc. | QSY |
| Sep 7, 2011 | K102944 | CORELEADER HEMO-PAD MODEL CPII 02030 Coreleader Biotech Co., Ltd., TW | QSY |
| Jun 16, 2011 | K103641 | GUARDACARE Hem Con Medical Technologies, Inc. | QSY |
| May 17, 2011 | K111163 | CHITOGAUZE FUSION Hem Con Medical Technologies, Inc. | QSY |
| May 10, 2011 | K110386 | CELOX RAPID GAUZE Medtrade Products , Ltd., GB | QSY |
| Mar 23, 2011 | K103245 | CELSTAT Baxter Healthcare Corp | QSY |
| Feb 2, 2011 | K102742 | NASAL CEASE Catalina, Inc. | QSY |
| Dec 8, 2010 | K102965 | CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TRAUMA GAUZE AG, OMNI-STAT HEMOSTATIC ANTI Medtrade Products , Ltd., GB | QSY |
| Dec 3, 2010 | K102459 | NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGE Hemostasis, LLC | QSY |
| Nov 17, 2010 | K102546 | CHITOGAUZE Hem Con Medical Technologies, Inc. | QSY |
| Sep 22, 2010 | K101097 | CALGAESEAL MODEL: CAS Bz Medical, Inc. | QSY |
| Jun 8, 2010 | K093729 | GUARDIVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 IN/ 4MM, STERILE, GUARD IVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 I Hemcon Medical Technologies Europe, Ltd. | QSY |
| Jan 20, 2010 | K093593 | CELOX PRO, CELOX PRO OTC, CELOX HEMOSTATIC GRANULES, CELOX PRO HEMOSTATIC GRANULES, OMNI STAT PRO Medtrade Products Limited, GB | QSY |
| Jan 14, 2010 | K093519 | MEDTRADE PRODUCTS CELOX VASCULAR TOPICAL HEMOSTATIC GRANULES ON SHEET Medtrade Products , Ltd., GB | QSY |
| Nov 20, 2009 | K091795 | MEDTRADE PRODUCTS CELOX TRAUMA GAUZE Medtrade Products , Ltd., GB | QSY |
| Nov 20, 2009 | K090780 | MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC PASTE Medtrade Products , Ltd., GB | QSY |
| Sep 4, 2009 | K092552 | CLO-SURPLUS P.A.D. Scion Cardio-Vascular, Inc. | QSY |
| Aug 25, 2009 | K092357 | 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 Hem Con Medical Technologies, Inc. | QSY |
| May 18, 2009 | K091194 | ALGISEAL PAD Evolution Medical Technologies, LLC | QSY |
| Apr 8, 2009 | K090620 | QUIKCLOT INTEVENTIONAL, MODEL P/N 182 Z-Medica Corporation | QSY |
| Mar 31, 2009 | K090026 | CHITOGAUZE, MODELS 130, 131, 263, 264, 265, 266 Hem Con Medical Technologies, Inc. | QSY |
| Mar 11, 2009 | K090100 | SOFTSEAL-STF Chitogen, Inc. | QSY |
| Feb 10, 2009 | K080210 | PRO QR ADVANCED FORMULA POWDER Biolife, LLC | QSY |
| Nov 12, 2008 | K080532 | BENACEL, MODELS C-001, C-002 AND C-005 Unicare Biomedical, Inc. | QSY |
| Oct 9, 2008 | K082601 | UltraClot, UltraClot OTC Emergency Medical Devices, LLC | QSY |
| Aug 6, 2008 | K072486 | MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC Hem Con Medical Technologies, Inc. | QSY |
| Jul 9, 2008 | K080097 | MEDTRADE PRODUCTS CELOX HEMOSTATIC GRANULES ON SHEET Medtrade Products , Ltd., GB | QSY |
| Jun 19, 2008 | K081183 | WOUNDSTAT Traumacure, Inc. | QSY |
| May 15, 2008 | K080818 | HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING Hem Con Medical Technologies, Inc. | QSY |
| May 7, 2008 | K080648 | TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE Ore-Medix, LLC | QSY |
| Dec 21, 2007 | K072328 | MEDTRADE PRODUCTS CELOX SOLBAG, ANTI - COAGULANT Medtrade Products , Ltd., GB | QSY |
| Dec 10, 2007 | K072890 | STASILON FR Entegrion, Inc. | QSY |
| Nov 2, 2007 | K072681 | BLOODSTOP HEMOSTATIC GAUZE; IX HEMOSTATIC GAUZE Lifescience Plus, Inc. | QSY |
| Oct 26, 2007 | K072900 | EXCELARREST FOAM Hemostasis, LLC | QSY |
| Oct 23, 2007 | K070520 | PRO QR (QUICK RELIEF) POWDER (FOR MINOR EXTERNAL BLEEDING FROM WOUNDS & PROCEDURES) Biolife, LLC | QSY |
| Oct 16, 2007 | K072474 | QUIKCLOT EX Z-Medica Corporation | QSY |
| Sep 27, 2007 | K071578 | BLOODSTOP AND BLOODSTOP IX HEMOSTATIC GAUZE, MODELS BS-10,BS-11,BS-12,B-13, BS-IX27, BS-IX-14, BSIX-15, BSIX-17 Lifescience Plus, Inc. | QSY |
| Aug 23, 2007 | K071936 | WOUNDSTAT, MODEL TC1001 Traumacure, Inc. | QSY |
| Aug 21, 2007 | K063190 | SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC Noble Fiber Technologies, Inc. | QSY |
| Aug 6, 2007 | K071519 | HEMCON CHITOFLEX-SURGICAL DRESSING Hemcon, Inc. | QSY |
| Jul 25, 2007 | K070175 | AQUANOVA SUPER-ABSORBENT GELLING DRESSING, OTC Medtrade Products , Ltd., GB | QSY |
| Apr 5, 2007 | K070211 | TRAUMARREST AND BLEEDARREST HEMOSTATIC PARTICLES AND FOAM Hemostasis, LLC | QSY |
| Jan 25, 2007 | K070010 | QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER Z-Medica Corporation | QSY |
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