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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

Decided510(k)Device and applicantCode
Oct 30, 2020K202157PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PIC
Smith & Nephew Medical Limited, GB
OMP
Oct 23, 2020K200223PocketDoc™ Micro Wound Therapy System
Pensar Medical, LLC
OMP
Jul 31, 2020K191101Kendall NPWT Incision Management Dressing Kit
Cardinalhealth
OMP
Jul 8, 2020K201571ACTIV.A.C. Negative Pressure Wound Therapy System
Kci USA, Inc.
OMP
May 18, 2020K200390V.A.C. DERMATAC Drape
Kci USA, Inc.
OMP
Jan 15, 2020K190028UNO 30
Genadyne Biotechnologies
OMP
Dec 5, 2019K191760PICO 14 Single Use Negative Pressure Wound Therapy System
Smith & Nephew Medical Limited, GB
OMP
Nov 22, 2019K190697PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag)
Kci USA, Inc.
OMP
Nov 1, 2019K190119Foryou NPWT Dressing Kit
4l Health Co., Ltd., CN
OMP
Sep 27, 2019K182722XLR8 Abdominal Wound Dressing Kit
Genadyne Biotechnologies
OMP
Jul 2, 2019K191460PWD Platform Wound Dressing 3” x 5” Oblong
Applied Tissue Technologies, LLC
OMP
May 23, 2019K182458Longterm NPWT Foam Dressing Kit
Zhejiang Longterm Medical Technology Co., Ltd., CN
OMP
Mar 28, 2019K181505V.A.C. DERMATAC Drape
Kci USA, Inc.
OMP
Mar 27, 2019K181929MiMo(TM) Negative Pressure Wound Therapy System
Baymax Research, Inc.
OMP
Mar 21, 2019K181822RENASYS Touch; RENASYS Y-Connector
Smith & Nephew Medical Limited, GB
OMP
Mar 20, 2019K183543ACTIV.A.C. Therapy Unit
Kci USA, Inc.
OMP
Feb 15, 2019K181507PREVENA RESTOR(TM) Incision Management System
Kci USA, Inc.
OMP
Feb 1, 2019K182191Invia Abdominal Dressing Kit
Medela AG, CH
OMP
Jan 18, 2019K182323PICO 7Y Single Use Negative Pressure Wound Therapy System
Smith & Nephew Medical Limited, GB
OMP
Jan 11, 2019K182409Applied Tissue Technologies PWD™ Platform Wound Dressing
Applied Tissue Technologies, LLC
OMP
Jan 10, 2019K181204RENASYS Y-Connector; RENASYS TOUCH
Smith & Nephew Medical Limited, GB
OMP
Nov 30, 2018K180840UNO Negative Pressure Wound Therapy System
Genadyne Biotechnologies, Inc.
OMP
Nov 2, 2018K180415Invia White Foam NPWT
Medela AG, CH
OMP
Oct 19, 2018K180205AVELLE Negative Pressure Wound Therapy System
Convatec Limited, GB
OMP
Aug 21, 2018K180698PICO 7 Single Use Negative Pressure Wound Therapy System
Smith & Nephew Medical Limited, GB
OMP
Aug 9, 2018K173407VT - 100, VT - 200
Carilex Medical, Inc., TW
OMP
Jun 8, 2018K172725VT Dressing Kits
Carilex Medical, Inc., TW
OMP
Jun 1, 2018K180855Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System
Kci USA, Inc.
OMP
May 9, 2018K172145Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia
Medela AG, CH
OMP
Apr 20, 2018K180618PICO Single Use Negative Pressure Wound Therapy System
Smith & Nephew Medical Limited, GB
OMP
Apr 6, 2018K180614PICO Single Use Negative Pressure Wound Therapy System
Smith & Nephew Medical Limited, GB
OMP
Mar 9, 2018K173426PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System
Kci USA, Inc.
OMP
Mar 2, 2018K173447V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit
Kci USA, Inc.
OMP
Feb 2, 2018K172005PICO 7 Single Use Negative Pressure Wound Therapy System
Smith & Nephew Medical Limited, GB
OMP
Sep 22, 2017K171499Occlusion Detection Dressing Kit
Cardinalhealth
OMP
Sep 20, 2017K172521PICO Single Use Negative Pressure Wound Therapy System
Smith & Nephew Medical Limited, GB
OMP
Sep 15, 2017K172519PICO Single Use Negative Pressure Wound Therapy System
Smith & Nephew Medical Limited, GB
OMP
Jun 8, 2017K162610NEXA Negative Pressure Wound Therapy System
Nexa Medical , Ltd., GB
OMP
Apr 28, 2017K162159VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing
Vr Medical Technologies, LLC, CN
OMP
Apr 18, 2017K163387PICO Single Use Negative Pressure Wound Therapy System
Smith & Nephew Medical Limited, GB
OMP
Apr 6, 2017K170088Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia
Medela AG, CH
OMP
Apr 6, 2017K161599UNO Negative Pressure Wound Therapy System
Genadyne Biotechnologies, Inc.
OMP
Feb 8, 2017K161432MyNeWT Negative Pressure Wound Therapy System
Stortford Medical, LLC
OMP
Jan 26, 2017K162790V.A.C.ULTA Negative Pressure Wound Therapy System
Kci USA, Inc. (Kinetic Concepts, Inc.)
OMP
Jan 19, 2017K161418Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set
Cardinalhealth
OMP
Dec 9, 2016K160487V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System
Kci USA, Inc.
OMP
Dec 1, 2016K161128Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy Syst
Medela AG, CH
OMP
Dec 1, 2016K150960WoundPro Negative Pressure Wound Therapy System
Pensar Medical, LLC
OMP
Nov 4, 2016K161935Avance Foam Dressing Kit - XL
Molnlycke Health Care Us, LLC
OMP
Nov 3, 2016K161948Avance Gauze Dressing Kits
Molnlycke Health Care Us, LLC
OMP

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