FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K222859 |
3M |
3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place Dressing Kit, Medium (EZ10MED), 3M V.A.C. Peel and Place Dressing Kit, Large (EZ10LRG) |
03/23/2023 |
K220560 |
3M |
Dermatac Drape |
07/14/2022 |
K221585 |
3M Health Care Business Group |
3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit |
03/23/2023 |
K211521 |
3M Health Care Business Group |
3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG) |
12/20/2021 |
K212320 |
3M Health Care Business Group |
DermatacÖ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring Se |
09/28/2021 |
K220660 |
3M Health Care Business Group |
Prevena Restor Adapti-Form Dressing |
07/01/2022 |
K190119 |
4L Health Co., Ltd. |
Foryou NPWT Dressing Kit |
11/01/2019 |
K100823 |
ACCURO MEDICAL PRODUCTS LLC |
WOUND PRO APEX |
01/24/2011 |
K221223 |
Alleva Medical Devices |
extriCARE« 3000 Negative Wound Pressure Therapy System |
02/09/2023 |
K213906 |
Alleva Medical Ltd |
extriCARE 1000 Negative Pressure Wound Therapy System |
03/08/2023 |
K182409 |
Applied Tissue Technologies LLC |
Applied Tissue Technologies PWDÖ Platform Wound Dressing |
01/11/2019 |
K212359 |
Applied Tissue Technologies LLC |
PWD Negative Pressure Wound Therapy System |
09/21/2022 |
K191460 |
Applied Tissue Technologies LLC |
PWD Platform Wound Dressing 3ö x 5ö Oblong |
07/02/2019 |
K141033 |
ARGENTUM MEDICAL, LLC |
SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON EASY AG ANTIMICROBIAL WOUND CONTACT NEGATIV |
09/12/2014 |
K090130 |
ATMOS INC. |
ATMOS S041 WOUND |
04/02/2009 |
K181929 |
Baymax Research, Inc. |
MiMo(TM) Negative Pressure Wound Therapy System |
03/27/2019 |
K133333 |
BLUE OCEAN MEDICAL PRODUCT, LLC. |
UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT |
12/31/2014 |
K061367 |
BLUE SKY MEDICAL GROUP INCORPORATED |
BLUESKY VISTA WOUND VACUUM SYSTEM, MODEL 100.0500 |
08/10/2006 |
K052456 |
BLUE SKY MEDICAL GROUP INCORPORATED |
MODIFICATION TO VERSATILE 1 WOUND VACUUM SYSTEM |
11/04/2005 |
K061919 |
BLUE SKY MEDICAL GROUP INCORPORATED |
VERSATILE 1 EZCARE WOUND VACUUM SYSTEM |
02/05/2007 |
K042134 |
BLUE SKY MEDICAL GROUP INCORPORATED |
VERSATILE 1 WOUND VACUUM SYSTEM |
11/01/2004 |
K061788 |
BOEHRINGER LABORATORIES |
BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM |
07/11/2006 |
K161418 |
CARDINAL HEALTH |
Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set |
01/19/2017 |
K150124 |
CARDINAL HEALTH |
Cardinal Health NPWT PRO HC |
09/02/2015 |
K143016 |
CARDINAL HEALTH |
Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home |
04/20/2015 |
K202217 |
Cardinal Health |
Kendall NPWT Incision Management Device |
06/04/2021 |
K191101 |
Cardinal Health |
Kendall NPWT Incision Management Dressing Kit |
07/31/2020 |
K171499 |
Cardinal Health |
Occlusion Detection Dressing Kit |
09/22/2017 |
K142916 |
CARDINAL HEALTH |
SVED Wound Treatment System |
03/04/2015 |
K173407 |
Carilex Medical, Inc. |
VT - 100, VT - 200 |
08/09/2018 |
K172725 |
Carilex Medical, Inc. |
VT Dressing Kits |
06/08/2018 |
K161410 |
CARILEX MEDICAL, INC. |
VT╖One, VT╖One 60days |
10/13/2016 |
K122490 |
CGBIO CO., LTD |
KULAVAC |
11/13/2013 |
K211277 |
Clear Choice Therapeutics, Inc. |
Theia NPWT Foam Wound Dressing Kit |
12/16/2021 |
K180205 |
ConvaTec Limited |
AVELLE Negative Pressure Wound Therapy System |
10/19/2018 |
K140022 |
CORK MEDICAL PRODUCTS LLC |
NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS NPWT CANISTER 500-ML, CORK MEDICAL PRODUCT |
10/24/2014 |
K203693 |
Cork Medical Products, LLC |
Nisus Touch Negative Pressure Wound Therapy Pump |
08/13/2021 |
K132004 |
CREO QUALITY, LLC. |
NPWT WOUND DRESSING KIT- MEDIUM, NPWT WOUND DRESSING KIT- LARGE |
05/02/2014 |
K132252 |
DEVON MEDICAL |
EXTRICARE 100CC/ 250CC/ 400CC CANISTERS |
09/27/2013 |
K132225 |
DEVON MEDICAL INC. |
EXTRICARE |
05/15/2014 |
K131464 |
DEVON MEDICAL INC. |
EXTRICARE NPWT FOOT DRESSING |
08/13/2013 |
K143362 |
Devon Medical Products |
extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister |
02/03/2015 |
K151240 |
Devon Medical Products |
extriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 7pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 6pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 5pc, extriCARE Negative |
06/09/2015 |
K110078 |
DEVON MEDICAL PRODUCTS, INC. |
EXTRICARE |
02/10/2012 |
K140634 |
Devon Medical, Inc. |
extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam Dressing Kit |
09/19/2014 |
K113236 |
FORYOU MEDICAL ELECTRONICS CO, LTD |
FORYOU NPWT DEVICE |
02/12/2013 |
K190028 |
Genadyne Biotechnologies |
UNO 30 |
01/15/2020 |
K182722 |
Genadyne Biotechnologies |
XLR8 Abdominal Wound Dressing Kit |
09/27/2019 |
K221891 |
Genadyne Biotechnologies, Inc |
UNO Negative Pressure Wound Therapy System |
12/14/2022 |
K142646 |
Genadyne Biotechnologies, Inc |
XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and |
04/30/2015 |
K092992 |
GENADYNE BIOTECHNOLOGIES, INC. |
A4-XLR8 FOAM DRESSING |
06/29/2010 |
K082676 |
GENADYNE BIOTECHNOLOGIES, INC. |
GENADYNE A4 WOUND VACUUM SYSTEM |
12/18/2008 |
K090638 |
GENADYNE BIOTECHNOLOGIES, INC. |
GENADYNE A4-XLR8 WOUND VACUUM SYSTEM |
04/29/2009 |
K221888 |
Genadyne Biotechnologies, Inc. |
Genadyne Hybrid Foam Dressings |
06/12/2023 |
K141961 |
GENADYNE BIOTECHNOLOGIES, INC. |
GENADYNE SPIRO FOAM DRESSING KIT |
03/26/2015 |
K210107 |
Genadyne Biotechnologies, Inc. |
Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System |
06/01/2022 |
K161599 |
GENADYNE BIOTECHNOLOGIES, INC. |
UNO Negative Pressure Wound Therapy System |
04/06/2017 |
K180840 |
Genadyne Biotechnologies, Inc. |
UNO Negative Pressure Wound Therapy System |
11/30/2018 |
K141437 |
GENADYNE BIOTECHNOLOGIES, INC. |
XLR8 PLUS (XLR8+) |
09/19/2014 |
K143726 |
GENADYNE BIOTECHNOLOGIES, INC. |
XLR8 PLUS (XLR8+) |
06/19/2015 |
K080275 |
IASIS MEDICAL, INC. |
NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM |
10/09/2008 |
K071301 |
INNOVATIVE THERAPIES, INC. |
ANTLIA I WOUND IRRIGATION SYSTEM |
05/24/2007 |
K070904 |
INNOVATIVE THERAPIES, INC. |
ANTLIA II SUCTION PUMP SYSTEM |
04/13/2007 |
K111333 |
INNOVATIVE THERAPIES, INC. |
ANTLIA III WOUND TREATMENT SYSTEM |
08/08/2011 |
K093564 |
INNOVATIVE THERAPIES, INC. |
SVED WOUND TREATMENT SYSTEM |
11/25/2009 |
K142956 |
Integrated Healing Technologies |
NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome Kit |
02/24/2015 |
K143301 |
Integrated Healing Technologies |
NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit |
03/03/2015 |
K121817 |
IVT MEDICAL LTD |
VCARE A |
09/17/2013 |
K201571 |
KCI USA, Inc |
ACTIV.A.C. Negative Pressure Wound Therapy System |
07/08/2020 |
K200390 |
KCI USA, Inc |
V.A.C. DERMATAC Drape |
05/18/2020 |
K183543 |
KCI USA, Inc. |
ACTIV.A.C. Therapy Unit |
03/20/2019 |
K120033 |
KCI USA, INC. |
ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT |
05/31/2012 |
K123507 |
KCI USA, INC. |
KCI NPWT GAUZE DRESSING |
04/04/2013 |
K053627 |
KCI USA, INC. |
MODIFICATION TO: V.A.C. GRANUFOAM SILVER PROTECTION DRESSING |
02/06/2006 |
K083357 |
KCI USA, INC. |
OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CANISTER, MODEL 370510 |
03/04/2009 |
K100821 |
KCI USA, INC. |
PREVENA INCISION MANAGEMENT SYSTEM |
06/11/2010 |
K150006 |
KCI USA, INC. |
Prevena Incision Management System with Peel & Place Dressing, Prevena Incision Management System with Customizable Dressing |
11/06/2015 |
K190697 |
KCI USA, Inc. |
PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag) |
11/22/2019 |
K153199 |
KCI USA, INC. |
Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit with Customizable Dressing, Prevena Plus Customizable Dressing 5-Pack |
02/29/2016 |
K173426 |
KCI USA, INC. |
PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System |
03/09/2018 |
K180855 |
KCI USA, Inc. |
Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System |
06/01/2018 |
K181507 |
KCI USA, Inc. |
PREVENA RESTOR(TM) Incision Management System |
02/15/2019 |
K111280 |
KCI USA, INC. |
V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT |
07/21/2011 |
K063426 |
KCI USA, INC. |
V.A.C. ATS LARGE (1000 ML) CANISTER WITH GEL, MODELS M6275093/5, M6275093/10 |
12/13/2006 |
K181505 |
KCI USA, Inc. |
V.A.C. DERMATAC Drape |
03/28/2019 |
K063590 |
KCI USA, INC. |
V.A.C. FREEDOM CANISTER, MODEL M6275421; V.A.C. ATS CANISTER, MODELS K6275422, M6275423 |
01/25/2007 |
K133276 |
KCI USA, INC. |
V.A.C. GRANUFOAM DRESSING, GRANUFOAM THIN DRESSING, GRANUFOAM ROUND DRESSING, GRANUFOAM SILVER DRESSING, WHITEFOAM DRESS |
11/19/2013 |
K160487 |
KCI USA, Inc. |
V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System |
12/09/2016 |
K063740 |
KCI USA, INC. |
V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766 |
06/07/2007 |
K063692 |
KCI USA, INC. |
V.A.C. THERAPY SYSTEMS-ACTI V.A.C. THERAPY UNIT MODEL# 340000 |
06/07/2007 |
K132741 |
KCI USA, INC. |
V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEM |
11/15/2013 |
K173447 |
KCI USA, Inc. |
V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit |
03/02/2018 |
K091585 |
KCI USA, INC. |
VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100 |
12/29/2009 |
K120499 |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM |
10/05/2012 |
K161897 |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings |
10/04/2016 |
K133232 |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA INCISION MANAGEMANT SYSTEM WITH PEEL& PLACE DRES |
03/24/2014 |
K123878 |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING |
01/15/2013 |
K121883 |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT |
10/11/2012 |
K141017 |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, |
08/20/2015 |
K160451 |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... |
06/20/2016 |
K102956 |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
V.A.C. GRANUFOAM SILVER SMALL DRESSING; V.A.C. GRANUFOAM SILVER MEDIUM DRESSING; V.A.C. GRANUFOAM SILVER LARGE DRESSING |
12/15/2010 |
K062227 |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
V.A.C. THERAPY SYSTEM |
10/04/2006 |
K100657 |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY SYSTEM) MODEL V.A.C. ULTA THERAPY UNIT MODEL U |
09/17/2010 |
K103156 |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
V.A.C. VERAFLO CLEANSE DRESSING SYSTEM |
03/14/2011 |
K093526 |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM D |
03/10/2010 |
K162790 |
KCI USA, Inc. (Kinetic Concepts, Inc.) |
V.A.C.ULTA Negative Pressure Wound Therapy System |
01/26/2017 |
K203316 |
KCI, a part of 3M Health Care Business Group |
V.A.C.ULTA Negative Pressure Wound Therapy System |
10/27/2021 |
K113199 |
KEVO MEDICAL SUPPLIES |
KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT |
07/30/2012 |
K971548 |
KINETIC CONCEPTS, INC. |
AMBUVAC |
05/22/1997 |
K032310 |
KINETIC CONCEPTS, INC. |
MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS |
10/10/2003 |
K041642 |
KINETIC CONCEPTS, INC. |
V.A.C. GRANUFOAM SILVER DRESSING |
01/25/2005 |
K050261 |
KINETIC CONCEPTS, INC. |
V.A.C. GRANUFOAM SILVER PROTECTION DRESSING |
05/26/2005 |
K021501 |
KINETIC CONCEPTS, INC. |
V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT |
12/02/2002 |
K992448 |
KINETIC CONCEPTS, INC. |
V.A.C. PLUS |
01/18/2000 |
K021500 |
KINETIC CONCEPTS, INC. |
VACUUM ASSISTED CLOSURE |
12/20/2002 |
K161570 |
LC Medical Concepts, Inc. |
Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large |
08/29/2016 |
K202898 |
Lightstone Medical Products (Ningbo) Co Ltd |
Tzoar 207 Negative Pressure Wound Therapy (NPWT) System |
12/30/2021 |
K182191 |
Medela AG |
Invia Abdominal Dressing Kit |
02/01/2019 |
K214112 |
Medela AG |
Invia Ease Negative Pressure Wound Therapy (NPWT) System |
07/26/2022 |
K141926 |
MEDELA AG |
INVIA ENDURE NEGATIVE PRESSURE WOUND THERAPY SYSTEM |
12/19/2014 |
K151261 |
Medela AG |
Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit Large |
10/07/2015 |
K172145 |
Medela AG |
Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion û 120 days, Invia Motion û 60 days, Invia Motion û 30 days, Invia Motion û 15 days, Invia Motion û 7 days), Invia Liberty Negati |
05/09/2018 |
K113678 |
MEDELA AG |
INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM |
10/01/2012 |
K161128 |
Medela AG |
Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply |
12/01/2016 |
K180415 |
Medela AG |
Invia White Foam NPWT |
11/02/2018 |
K223388 |
Medela AG |
Invia« Integrated Dressing |
07/07/2023 |
K080357 |
MEDELA AG |
MEDELA INVIA WOUND THERAPY |
07/24/2008 |
K061435 |
MEDELA AG |
MEDELA VARIO SUCTION PUMPS |
06/08/2006 |
K170088 |
MEDELA, AG |
Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film |
04/06/2017 |
K142626 |
MEDELA, AG |
Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set, Y-connector, Drain Adaptor, Invia Liberty Canisters |
06/12/2015 |
K112458 |
MEDICA-RENTS CO., LTD. |
PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEM |
01/05/2012 |
K122132 |
MOLNLYCKE HEALTH CARE |
AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM |
01/17/2013 |
K141847 |
MOLNLYCKE HEALTH CARE US, LLC |
AVANCE FOAM DRESSING KITS |
03/26/2015 |
K203369 |
Molnlycke Health Care US, LLC |
Avance Solo Negative Pressure Wound Therapy (NPWT) System |
07/01/2021 |
K161935 |
MOLNLYCKE HEALTH CARE, US LLC |
Avance Foam Dressing Kit - XL |
11/04/2016 |
K161948 |
MOLNLYCKE HEALTH CARE, US LLC |
Avance Gauze Dressing Kits |
11/03/2016 |
K161797 |
MOLNLYCKE HEALTH CARE, US LLC |
Avance Tubing, Avance Y-Connector, Avance ViewPad |
10/19/2016 |
K151872 |
MOLNLYCKE HEALTH CARE, US LLC |
Avance Y-Connector S |
11/02/2015 |
K152741 |
MOLNLYCKE HEALTH CARE, US LLC |
Mepiseal Soft Silicone Sealant |
01/22/2016 |
K111949 |
NANO VIBRONIX, INC. |
AC WOUND TREATMENT SYSTEM |
06/29/2012 |
K032301 |
NEOGEN TECHNOLOGIES, INC |
NEOGEN ONE, CLOSED WOUND DRAIN SYSTEM, PART NUMBER: NG9900 |
08/21/2003 |
K162610 |
Nexa Medical Ltd. |
NEXA Negative Pressure Wound Therapy System |
06/08/2017 |
K062456 |
NOVASPINE LLC |
NOVASPINE POWERED SUCTION PUMP PRO-1 |
10/16/2006 |
K150960 |
PENSAR MEDICAL LLC |
WoundPro Negative Pressure Wound Therapy System |
12/01/2016 |
K200223 |
Pensar Medical, LLC |
PocketDocÖ Micro Wound Therapy System |
10/23/2020 |
K132936 |
POLYNOVO BIOMATERIALS PTY LTD |
NOVOPORE DRESSING |
03/04/2014 |
K082415 |
PREMCO MEDICAL SYSTEMS, INC. |
PRODIGY NPWT SYSTEM MODEL PRODIGY 800V |
11/25/2008 |
K150459 |
SIMEX MEDIZINTECHNIK GmbH |
FloSure Ventilation Patch |
01/05/2016 |
K113291 |
SIMEX MEDIZINTECHNIK GMBH |
SIMEX NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMPS SERIES: SIM-EX200 AND SIM-EX300 |
08/30/2012 |
K191760 |
Smith & Nephew Medical Limited |
PICO 14 Single Use Negative Pressure Wound Therapy System |
12/05/2019 |
K172005 |
Smith & Nephew Medical Limited |
PICO 7 Single Use Negative Pressure Wound Therapy System |
02/02/2018 |
K180698 |
Smith & Nephew Medical Limited |
PICO 7 Single Use Negative Pressure Wound Therapy System |
08/21/2018 |
K202157 |
Smith & Nephew Medical Limited |
PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Pack |
10/30/2020 |
K182323 |
Smith & Nephew Medical Limited |
PICO 7Y Single Use Negative Pressure Wound Therapy System |
01/18/2019 |
K163387 |
Smith & Nephew Medical Limited |
PICO Single Use Negative Pressure Wound Therapy System |
04/18/2017 |
K172519 |
Smith & Nephew Medical Limited |
PICO Single Use Negative Pressure Wound Therapy System |
09/15/2017 |
K172521 |
Smith & Nephew Medical Limited |
PICO Single Use Negative Pressure Wound Therapy System |
09/20/2017 |
K180614 |
Smith & Nephew Medical Limited |
PICO Single Use Negative Pressure Wound Therapy System |
04/06/2018 |
K180618 |
Smith & Nephew Medical Limited |
PICO Single Use Negative Pressure Wound Therapy System |
04/20/2018 |
K223041 |
Smith & Nephew Medical Limited |
Renasys Edge (66803126) |
11/22/2022 |
K181822 |
Smith & Nephew Medical Limited |
RENASYS Touch; RENASYS Y-Connector |
03/21/2019 |
K181204 |
Smith & Nephew Medical Limited |
RENASYS Y-Connector; RENASYS TOUCH |
01/10/2019 |
K202783 |
Smith & Nephew Medical Limited |
Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing |
01/14/2022 |
K151436 |
SMITH & NEPHEW MEDICAL LTD |
PICO Single Use Negative Pressure Wound Therapy System |
01/28/2016 |
K153209 |
SMITH & NEPHEW MEDICAL LTD. |
RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply |
08/04/2016 |
K082211 |
Smith & Nephew, Inc |
RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS |
11/14/2008 |
K102001 |
SMITH & NEPHEW, INC. |
MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY |
08/06/2010 |
K111170 |
SMITH & NEPHEW, INC. |
PICO |
12/15/2011 |
K112127 |
SMITH & NEPHEW, INC. |
PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM |
05/16/2012 |
K091470 |
SMITH & NEPHEW, INC. |
RANASYS EZ NEGATIVE PRESSURE WOUND THERAPY SYSTEM, MODEL 66800059 |
07/09/2009 |
K082426 |
SMITH & NEPHEW, INC. |
RENASYS EZ |
09/05/2008 |
K132446 |
SMITH & NEPHEW, INC. |
RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE |
10/23/2013 |
K110647 |
SMITH & NEPHEW, INC. |
RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS |
06/22/2011 |
K152163 |
SMITH & NEPHEW, INC. |
RENASYS GO |
09/29/2016 |
K083375 |
SMITH & NEPHEW, INC. |
RENASYS GO NEGATIVE PRESSURE WOUND THERAPY |
02/25/2009 |
K162129 |
Smith & Nephew, Inc. |
RENASYS-G Gauze Dressing Kits with Soft Port |
08/31/2016 |
K142979 |
SMITH & NEPHEW, INC. |
RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft Port; Gauze NPWT Wound Dressing Kits with Soft Port; EZ PLUS/EZ MAX Canisters |
04/29/2015 |
K143133 |
SMITH & NEPHEW, INC. |
RENASYS┐ EZ MAX Negative Pressure Wound Therapy Device, RENASYS┐ AB Abdominal Dressing Kit with Soft Port Device |
07/23/2015 |
K151326 |
Smith & Nephew, Inc. |
RENASYS┐ EZ PLUS Negative Pressure Wound Therapy Device |
07/16/2015 |
K213853 |
Smith and Nephew Medical Limited |
RENASYSÖ-WF White Foam NPWT Dressing Small; RENASYSÖ-WF White Foam NPWT Dressing Large |
02/10/2023 |
K211318 |
Smith Nephew Medical Limited |
PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs |
01/05/2022 |
K161432 |
Stortford Medical LLC |
MyNeWT Negative Pressure Wound Therapy System |
02/08/2017 |
K112853 |
SUZRIC ENTERPRISE CO., LTD. |
VOLTERA POWERED SUCTION PUMP |
11/09/2012 |
K151263 |
TALLEY GROUP LTD. |
Venturi Gauze Wound Care Sets with Portal Drain |
02/19/2016 |
K143004 |
TALLEY GROUP LTD. |
VENTURI MiNO TG600/14 |
01/05/2016 |
K080897 |
TALLEY MEDICAL |
VENTURI NEGATIVE PRESSURE WOUND THERAPY SYSTEM |
07/15/2008 |
K090258 |
TALLEY MEDICAL |
VENTURI NPWT V. II ADVANCED VACUUM SYSTEM |
08/25/2009 |
K082311 |
THE MEDICAL COMPANY |
EXSUDEX WOUND DRAINAGE PUMP |
10/08/2008 |
K162159 |
VR Medical Technologies, LLC |
VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing |
04/28/2017 |
K142385 |
Wound RX Medical, LLC |
Whisper Pump System |
05/22/2015 |
K202823 |
Zhejiang Longterm Medical Technology Co., LTD |
Innomed NPWT Silicone Foam Dressing |
12/15/2021 |
K182458 |
Zhejiang Longterm Medical Technology Co., LTD |
Longterm NPWT Foam Dressing Kit |
05/23/2019 |
K211571 |
Zhejiang Longterm Medical Technology Co., LTD |
Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit |
05/31/2022 |