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

Negative Pressure Wound Therapy Powered Suction Pump

Regulation 878.4780

10510(k)s in 12 months (217 all time)
0recalls in 12 months (47 all time)
42recalls that name a 510(k)
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Top companies in OMP

Company510(k)sRecalls
Kci USA, Inc.2617
Smith & Nephew, Inc.1417
Smith & Nephew Medical Limited233
Genadyne Biotechnologies160
Medela AG132
Kci USA, Inc. (Kinetic Concepts, Inc.)130
Cardinalhealth70
Kinetic Concepts, Inc.70
Molnlycke Health Care Us, LLC70
Convatec Limited15
Decided510(k)Device and applicantCode
Oct 23, 2026K261982RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747)
Smith & Nephew Medical, Ltd., GB
OMP
Oct 8, 2026K260426MeCare Alpha (MCA2019)
IVT Medical, Ltd., IL
OMP
Sep 11, 2026K261338RENASYS DYNAFLOW Kit (66807741)
Smith & Nephew Medical, Ltd., GB
OMP
Jun 24, 2026K253263ConvaVAC™ Negative Pressure Wound Therapy System
Convatec Limited, Gdc Building, GB
OMP
Jun 23, 2026K253199CURASYS 2 (EMDN0003)
CG Bio Co., Ltd., KR
OMP
May 27, 2026K260646RENASYS EDGE (66803126)
Smith & Nephew Medical, Ltd., GB
OMP
May 21, 2026K261291Nisus NPWT Canister 500-mL (CPC-500)
Cork Medical
OMP
May 4, 2026K254019Wound Geni NPWT System
Bechtel Medical, Inc.
OMP
Mar 12, 2026K253429Genadyne ASTRA NPWT
Genadyne Biotechnologies, Inc.
OMP
Nov 21, 2025K250586Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory
Deroyal Industries, Inc.
OMP
Oct 3, 2025K251646extriCARE® 1000 Negative Pressure Wound Therapy System
Alleva Medical Devices
OMP
Sep 11, 2025K251826RENASYS WOUND+ Dressing Kit with AIRLOCK Technology
Smith & Nephew Medical, Ltd., GB
OMP
Jun 27, 2025K243187Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)
Cork Medical
OMP
Feb 18, 2025K243576RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Tec
Smith & Nephew Medical, Ltd., GB
OMP
Dec 23, 2024K233614Genadyne DUO NPWT
Genadyne Biotechnologies, Inc.
OMP
Aug 21, 2024K241061VERSA Negative Pressure Wound Therapy System (VCMPP-100)
Cork Medical
OMP
Aug 19, 2024K241023Negative Pressure Wound Therapy Device (V-Move, V-Grand)
Med Way, Inc.
OMP
Jul 26, 2024K241515NEXA™ NPWT System
Nexa Medical Limited, GB
OMP
May 24, 2024K231939Renasys Edge
Smith & Nephew Medical, Ltd., GB
OMP
May 23, 2024K2411343M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10)
Kci USA, Inc.
OMP
Apr 18, 2024K230233Prospera Spectruum Negative Pressure Wound Therapy System
Deroyal Industries, Inc.
OMP
Apr 17, 2024K231646Carilex VT¿200-i NX
Carilex Medical, Inc., TW
OMP
Feb 5, 2024K232379PREVENT Kit
Clear Choice Therapeutics
OMP
Dec 6, 2023K230677Cork Medical VERSA Negative Pressure Wound System (VCMPP-100)
Cork Medical
OMP
Jul 7, 2023K223388Invia® Integrated Dressing
Medela AG, CH
OMP
Jun 12, 2023K221888Genadyne Hybrid Foam Dressings
Genadyne Biotechnologies, Inc.
OMP
Mar 23, 2023K2228593M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place Dressing Kit, Medium (EZ10MED), 3M V.A.
3M
OMP
Mar 23, 2023K2215853M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit
3M Healthcare Business Group
OMP
Mar 8, 2023K213906extriCARE 1000 Negative Pressure Wound Therapy System
Alleva Medical, Ltd., HK
OMP
Feb 10, 2023K213853RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large
Smith and Nephew Medical Limited, GB
OMP
Feb 9, 2023K221223extriCARE® 3000 Negative Wound Pressure Therapy System
Alleva Medical Devices
OMP
Dec 14, 2022K221891UNO Negative Pressure Wound Therapy System
Genadyne Biotechnologies, Inc.
OMP
Nov 22, 2022K223041Renasys Edge (66803126)
Smith & Nephew Medical Limited, GB
OMP
Sep 21, 2022K212359PWD Negative Pressure Wound Therapy System
Applied Tissue Technologies, LLC
OMP
Jul 26, 2022K214112Invia Ease Negative Pressure Wound Therapy (NPWT) System
Medela AG, CH
OMP
Jul 14, 2022K220560Dermatac Drape
3M
OMP
Jul 1, 2022K220660Prevena Restor Adapti-Form Dressing
3M Healthcare Business Group
OMP
Jun 1, 2022K210107Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System
Genadyne Biotechnologies, Inc.
OMP
May 31, 2022K211571Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit
Zhejiang Longterm Medical Technology Co., Ltd., CN
OMP
Jan 14, 2022K202783Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing
Smith & Nephew Medical Limited, GB
OMP
Jan 5, 2022K211318PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PIC
Smith Nephew Medical Limited, GB
OMP
Dec 30, 2021K202898Tzoar 207 Negative Pressure Wound Therapy (NPWT) System
Lightstone Medical Products (Ningbo) Co, Ltd., CN
OMP
Dec 20, 2021K2115213M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG)
3M Healthcare Business Group
OMP
Dec 16, 2021K211277Theia NPWT Foam Wound Dressing Kit
Clear Choice Therapeutics, Inc.
OMP
Dec 15, 2021K202823Innomed NPWT Silicone Foam Dressing
Zhejiang Longterm Medical Technology Co., Ltd., CN
OMP
Oct 27, 2021K203316V.A.C.ULTA Negative Pressure Wound Therapy System
Kci, A Part of 3M Health Care Business Group
OMP
Sep 28, 2021K212320Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A
3M Healthcare Business Group
OMP
Aug 13, 2021K203693Nisus Touch Negative Pressure Wound Therapy Pump
Cork Medical Products, LLC
OMP
Jul 1, 2021K203369Avance Solo Negative Pressure Wound Therapy (NPWT) System
Molnlycke Health Care Us, LLC
OMP
Jun 4, 2021K202217Kendall NPWT Incision Management Device
Cardinalhealth
OMP

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