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)
Top companies in OMP
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 14, 2025 | KCI 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 |
OMP | K062227 |
| Nov 22, 2024 | KCI 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 |
OMP | K162790 |
| Nov 22, 2024 | Smith & 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 |
OMP | K223041 |
| Apr 18, 2024 | Smith & 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 |
OMP | K223041 |
| Apr 18, 2024 | Smith & 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 |
OMP | K223041 |
| Jun 8, 2020 | KCI 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 |
OMP | K183543 |
| Jun 4, 2020 | Cardinal 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 |
OMP | K143016 |
| Jun 4, 2020 | Cardinal 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 |
OMP | K143016 |
| Dec 2, 2019 | Medela 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 |
OMP | K170088 |
| Jul 23, 2018 | Medela 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 |
OMP | K161128 |
| Apr 28, 2017 | KCI 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 |
OMP | K063740 |
| Nov 11, 2016 | Smith & 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 |
OMP | K083375 |
| Nov 11, 2016 | Smith & 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 |
OMP | K083375 |
| Jul 21, 2016 | Smith & 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 |
OMP | K061919 K142979 |
| Jan 6, 2016 | KCI 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 |
OMP | None listed |
| Oct 15, 2014 | KCI 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 |
OMP | None listed |
| Oct 8, 2014 | Smith & 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 |
OMP | K082426 K102001 |
| Oct 8, 2014 | Smith & 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 |
OMP | K082426 K102001 |
| Oct 8, 2014 | Smith & 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 |
OMP | K082426 K102001 |
| Sep 23, 2014 | Smith & 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 |
OMP | K082426 |
| Mar 10, 2014 | Smith & 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 |
OMP | K110647 |
| Mar 10, 2014 | Smith & 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 |
OMP | K110647 |
| Mar 10, 2014 | Smith & 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 |
OMP | K110647 |
| Mar 10, 2014 | Smith & 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 |
OMP | K110647 |
| Mar 10, 2014 | Smith & 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 |
OMP | K110647 |
| Mar 10, 2014 | Smith & 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 |
OMP | K110647 |
| Mar 5, 2014 | KCI 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 |
OMP | K100821 K123878 |
| Mar 5, 2014 | KCI 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 |
OMP | K100821 K123878 |
| Mar 5, 2014 | KCI 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 |
OMP | K100821 K123878 |
| Mar 5, 2014 | KCI 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 |
OMP | K100821 K123878 |
| Mar 5, 2014 | KCI 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 |
OMP | K100821 K123878 |
| Mar 5, 2014 | KCI 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 |
OMP | K100821 K123878 |
| Mar 5, 2014 | KCI 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 |
OMP | K100821 K123878 |
| Mar 5, 2014 | KCI 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 |
OMP | K100821 K123878 |
| Feb 21, 2014 | Smith & Nephew Inc. Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System Terminated |
OMP | None listed |
| Feb 21, 2014 | Smith & Nephew Inc. Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System Terminated |
OMP | None listed |
| Oct 4, 2012 | Accuro 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 |
OMP | K100823 |
| Jan 26, 2012 | Smith & 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 |
OMP | K082211 |
| Nov 3, 2010 | Smith & 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 |
OMP | K091470 |
| Sep 28, 2010 | Convatec Inc. Engenex Non Acute Care Suction Pump for use with Engenex Negative Pressure Wound Therapy Terminated |
OMP | K061788 |
| Jan 25, 2010 | KCI 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 |
OMP | None listed |
| Jan 25, 2010 | KCI 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 |
OMP | K062227 K063740 |
| Jan 25, 2010 | KCI 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 |
OMP | K063692 |
| Sep 29, 2009 | ConvaTec 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 |
OMP | K061788 |
| Sep 9, 2009 | ConvaTec 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 |
OMP | K061788 |
| Sep 9, 2009 | ConvaTec 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 |
OMP | K061788 |
| Sep 9, 2009 | ConvaTec 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 |
OMP | K061788 |
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