FDA 510(k) Applications for Medical Device Product Code "OMP"
(Negative Pressure Wound Therapy Powered Suction Pump )

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


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