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Panels › General, Plastic Surgery › Product code OMP · Class 2

Negative Pressure Wound Therapy Powered Suction Pump

Regulation 878.4780

9510(k)s in 12 months (216 all time)
0recalls in 12 months (47 all time)
42recalls that name a 510(k)
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Top companies in OMP

DateFirm and productCodeLinked 510(k)
Feb 14, 2025KCI USA, INC.
3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit VIAKIT07S05/AU - V.A.C. VIA Starter Kit 65-Pack VIAKIT077D01/GB - V.A.C. VIA 7 Day Kit, Single Shipper
Open, Classified
OMPK062227
Nov 22, 2024KCI USA, INC.
V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C. Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy w
Open, Classified
OMPK162790
Nov 22, 2024Smith & Nephew Medical, Ltd.
RENASYS EDGE The RENASYS EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body
Open, Classified
OMPK223041
Apr 18, 2024Smith & Nephew Medical, Ltd.
RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing Product Number: 66803140
Open, Classified
OMPK223041
Apr 18, 2024Smith & Nephew Medical, Ltd.
RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing. Product Number: 66803139
Open, Classified
OMPK223041
Jun 8, 2020KCI USA, INC.
ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERICAN UDI (01)00878237008188 - Product Usage: is an integrated wound management system for use in the acute, extended, and home
Terminated
OMPK183543
Jun 4, 2020Cardinal Health 200, LLC
Cardinal Health NPWT Occlusion Detection Canister 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds,
Terminated
OMPK143016
Jun 4, 2020Cardinal Health 200, LLC
Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-th
Terminated
OMPK143016
Dec 2, 2019Medela Inc
Invia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224. The Invia Foam Dressing Kit with FitPad consists of a foam pad, a section interface (Invia FitPad) and Transparent Film (one or m
Terminated
OMPK170088
Jul 23, 2018Medela Inc
Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. Endure Negative Pressure Wound Therapy (Model 087.4010); b. 15 Days Negative Pressure Wound Therapy (Model 087.4012); c. 60
Terminated
OMPK161128
Apr 28, 2017KCI USA, INC.
1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number M8275093/5). The InfoV.A.C. and V.A.C.ULTA Negative Pressure Wound Therapy Systems are integrated wound manage
Terminated
OMPK063740
Nov 11, 2016Smith & Nephew, Inc.
Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit, Rx only. Intended for patients who would benefit from a suction device to help promote wound healing by removin
Open, Classified
OMPK083375
Nov 11, 2016Smith & Nephew, Inc.
Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. Intended for patients who would benefit from a suction device to help promote wound healing by removing fluids, including irrigat
Open, Classified
OMPK083375
Jul 21, 2016Smith & Nephew, Inc.
RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film Is intended for patients who would benefit from a suction device (negative pressur
Open, Classified
OMPK061919
K142979
Jan 6, 2016KCI USA, INC.
ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in the acute extended and home care settings. The software-controlled therapy unit applies nega
Terminated
OMPNone listed
Oct 15, 2014KCI USA, Inc.
V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection. Featuring SensaT.R.A.C. Technology REF M8275099/10 STERILE Single Use only Latex Free Rx Only.
Terminated
OMPNone listed
Oct 8, 2014Smith & Nephew, Inc.
RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated
Terminated
OMPK082426
K102001
Oct 8, 2014Smith & Nephew, Inc.
RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negativ
Terminated
OMPK082426
K102001
Oct 8, 2014Smith & Nephew, Inc.
RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negativ
Terminated
OMPK082426
K102001
Sep 23, 2014Smith & Nephew, Inc.
RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device may promote wound healing.
Terminated
OMPK082426
Mar 10, 2014Smith & Nephew Inc.
Smith & Nephew RENASYS-AB Abdominal Dressing Kit with Soft Port REF #'s: 66800980 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
Terminated
OMPK110647
Mar 10, 2014Smith & Nephew Inc.
Smith & Nephew RENASYS-G Sterile, Gauze Dressing Kit with Soft Port REF #'s: 66800961 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
Terminated
OMPK110647
Mar 10, 2014Smith & Nephew Inc.
Smith & Nephew RENASYS-Gauze with Soft Port Kit REF #'s: 66800933, 66800934, 66800935, and 66800936 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy
Terminated
OMPK110647
Mar 10, 2014Smith & Nephew Inc.
Smith & Nephew RENASYS-F XL with Soft Port REF #: 66800797 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
Terminated
OMPK110647
Mar 10, 2014Smith & Nephew Inc.
Smith & Nephew RENASYS-F Foam Dressing Kit with Soft Port REF #'s: 66800794, 66800795, and 66800796 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy
Terminated
OMPK110647
Mar 10, 2014Smith & Nephew Inc.
Smith & Nephew RENASYS Soft Port REF: 66800799 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
Terminated
OMPK110647
Mar 5, 2014KCI USA, INC.
PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain foll
Terminated
OMPK100821
K123878
Mar 5, 2014KCI USA, INC.
PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continu
Terminated
OMPK100821
K123878
Mar 5, 2014KCI USA, INC.
PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following suture
Terminated
OMPK100821
K123878
Mar 5, 2014KCI USA, INC.
PRE2001: Prevena Incision Management Customizable System Box Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain f
Terminated
OMPK100821
K123878
Mar 5, 2014KCI USA, INC.
PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following suture
Terminated
OMPK100821
K123878
Mar 5, 2014KCI USA, INC.
PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled
Terminated
OMPK100821
K123878
Mar 5, 2014KCI USA, INC.
PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain follo
Terminated
OMPK100821
K123878
Mar 5, 2014KCI USA, INC.
PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured
Terminated
OMPK100821
K123878
Feb 21, 2014Smith & Nephew Inc.
Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
Terminated
OMPNone listed
Feb 21, 2014Smith & Nephew Inc.
Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
Terminated
OMPNone listed
Oct 4, 2012Accuro Medical Product LLC
Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wo
Terminated
OMPK100823
Jan 26, 2012Smith & Nephew Inc.
***REF 66800694***Qty 10***smith&nephew***RENASYS Port Foam Dressing Kit Port***STERILE***Rx Only.***Made in Mexico for/Fabrique au Mexique pour: Smith & Nephew, Inc., St. Petersburg, FL 33716***Smith
Terminated
OMPK082211
Nov 3, 2010Smith & Nephew Inc.
smith&nephew EZCARE Negative Pressure Rx only. 100-240 V 12 V 50/60 Hz 90VA T1A 250 V Indicated for patients who would benefit from a suction device particularly as the device may promote healing
Terminated
OMPK091470
Sep 28, 2010Convatec Inc.
Engenex Non Acute Care Suction Pump for use with Engenex Negative Pressure Wound Therapy
Terminated
OMPK061788
Jan 25, 2010KCI USA, Inc.
AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord M426884 used with VAC ATS Canadian Model M8259994.
Terminated
OMPNone listed
Jan 25, 2010KCI USA, Inc.
AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #M4268882 used with InfoVAC Model M825999,, InvoVac Canadian Model M8260027, and Vac ATS Model 825
Terminated
OMPK062227
K063740
Jan 25, 2010KCI USA, Inc.
AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #340225 used with Activac Model 340000, and ActiVAC (Canadian) Model 340013.
Terminated
OMPK063692
Sep 29, 2009ConvaTec
ConvaTec, Engenex Tunnel Dressing, for use with Engenex Negative Pressure Wound Therapy, (1 x 15 cm) Rx only, Latex Free; Sterile Health Industry Bar Code: H984BWS4464509A. Packaged in boxes of 15 uni
Terminated
OMPK061788
Sep 9, 2009ConvaTec
Engenex Bio-Dome Easy Release Dressing Kit, XL; Product Code 446553; Advanced Negative Pressure Wound Therapy System; Sterile, box contains 15 units; Boehringer Wound Systems, LLC, Norristown, PA 1940
Terminated
OMPK061788
Sep 9, 2009ConvaTec
Engenex Cover Strip; Product Code 446471; Advanced Negative Wound Therapy System; Sterile, Boc contains 10 units; Boehringer Wound Systems, LLC, Norristown, PA 19404; Manufactured for: ConvaTec Inc.,
Terminated
OMPK061788
Sep 9, 2009ConvaTec
Engenex Wound Cover; Product Code 446470; Advanced Negative Pressure Wound Therapy System; Sterile, Box Contains 10 units. Boehringer Wound Systems, LLC, Norristown, PA 19404; Manufactured for: ConvaT
Terminated
OMPK061788

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