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)
Top companies in OMP
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 19, 2016 | K161797 | Avance Tubing, Avance Y-Connector, Avance ViewPad Molnlycke Health Care Us, LLC | OMP |
| Oct 13, 2016 | K161410 | VT·One, VT·One 60days Carilex Medical, Inc., TW | OMP |
| Oct 4, 2016 | K161897 | PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings Kci USA, Inc. (Kinetic Concepts, Inc.) | OMP |
| Sep 29, 2016 | K152163 | RENASYS GO Smith & Nephew, Inc. | OMP |
| Aug 31, 2016 | K162129 | RENASYS-G Gauze Dressing Kits with Soft Port Smith & Nephew, Inc. | OMP |
| Aug 29, 2016 | K161570 | Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit- Lc Medical Concepts, Inc. | OMP |
| Aug 4, 2016 | K153209 | RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y Smith & Nephew Medical, Ltd., GB | OMP |
| Jun 20, 2016 | K160451 | V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... Kci USA, Inc. (Kinetic Concepts, Inc.) | OMP |
| Feb 29, 2016 | K153199 | Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Preve Kci USA, Inc. | OMP |
| Feb 19, 2016 | K151263 | Venturi Gauze Wound Care Sets with Portal Drain Talley Group, Ltd., GB | OMP |
| Jan 28, 2016 | K151436 | PICO Single Use Negative Pressure Wound Therapy System Smith & Nephew Medical, Ltd., GB | OMP |
| Jan 22, 2016 | K152741 | Mepiseal Soft Silicone Sealant Molnlycke Health Care Us, LLC | OMP |
| Jan 5, 2016 | K150459 | FloSure Ventilation Patch Simex Medizintechnik GmbH, DE | OMP |
| Jan 5, 2016 | K143004 | VENTURI MiNO TG600/14 Talley Group, Ltd., GB | OMP |
| Nov 6, 2015 | K150006 | Prevena Incision Management System with Peel & Place Dressing, Prevena Incision Management System with Customizable Dres Kci USA, Inc. | OMP |
| Nov 2, 2015 | K151872 | Avance Y-Connector S Molnlycke Health Care Us, LLC | OMP |
| Oct 7, 2015 | K151261 | Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit Large Medela AG, CH | OMP |
| Sep 2, 2015 | K150124 | Cardinal Health NPWT PRO HC Cardinalhealth | OMP |
| Aug 20, 2015 | K141017 | PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, Kci USA, Inc. (Kinetic Concepts, Inc.) | OMP |
| Jul 23, 2015 | K143133 | RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing Kit with Soft Port Device Smith & Nephew, Inc. | OMP |
| Jul 16, 2015 | K151326 | RENASYS¿ EZ PLUS Negative Pressure Wound Therapy Device Smith & Nephew, Inc. | OMP |
| Jun 19, 2015 | K143726 | XLR8 PLUS (XLR8+) Genadyne Biotechnologies, Inc. | OMP |
| Jun 12, 2015 | K142626 | Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set, Y-connector, Drain Adaptor, Invia Libert Medela AG, CH | OMP |
| Jun 9, 2015 | K151240 | extriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 7pc, ex Devon Medical Products | OMP |
| May 22, 2015 | K142385 | Whisper Pump System Wound RX Medical, LLC | OMP |
| Apr 30, 2015 | K142646 | XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and Genadyne Biotechnologies, Inc. | OMP |
| Apr 29, 2015 | K142979 | RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft Port; Gauze NPWT Wound Dressing Smith & Nephew, Inc. | OMP |
| Apr 20, 2015 | K143016 | Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home Cardinalhealth | OMP |
| Mar 26, 2015 | K141961 | GENADYNE SPIRO FOAM DRESSING KIT Genadyne Biotechnologies, Inc. | OMP |
| Mar 26, 2015 | K141847 | AVANCE FOAM DRESSING KITS Molnlycke Health Care Us, LLC | OMP |
| Mar 4, 2015 | K142916 | SVED Wound Treatment System Cardinalhealth | OMP |
| Mar 3, 2015 | K143301 | NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit Integrated Healing Technologies | OMP |
| Feb 24, 2015 | K142956 | NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome Kit Integrated Healing Technologies | OMP |
| Feb 3, 2015 | K143362 | extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister Devon Medical Products | OMP |
| Dec 31, 2014 | K133333 | UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT Blue Ocean Medical Product, LLC | OMP |
| Dec 19, 2014 | K141926 | INVIA ENDURE NEGATIVE PRESSURE WOUND THERAPY SYSTEM Medela AG | OMP |
| Oct 24, 2014 | K140022 | NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS NPWT CANISTER 500-ML, CORK MEDICAL PRODUCT Cork Medical Products, LLC | OMP |
| Sep 19, 2014 | K141437 | XLR8 PLUS (XLR8+) Genadyne Biotechnologies, Inc. | OMP |
| Sep 19, 2014 | K140634 | extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam Dressing Kit Devon Medical, Inc. | OMP |
| Sep 12, 2014 | K141033 | SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON EASY AG ANTIMICROBIAL WOUND CONTACT NEGATIV Argentum Medical, LLC | OMP |
| May 15, 2014 | K132225 | EXTRICARE Devon Medical, Inc. | OMP |
| May 2, 2014 | K132004 | NPWT WOUND DRESSING KIT- MEDIUM, NPWT WOUND DRESSING KIT- LARGE Creo Quality, LLC | OMP |
| Mar 24, 2014 | K133232 | PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA INCISION MANAGEMANT SYSTEM WITH PEEL& PLACE DRES Kci USA, Inc. (Kinetic Concepts, Inc.) | OMP |
| Mar 4, 2014 | K132936 | NOVOPORE DRESSING Polynovo Biomaterials Pty, Ltd. | OMP |
| Nov 19, 2013 | K133276 | V.A.C. GRANUFOAM DRESSING, GRANUFOAM THIN DRESSING, GRANUFOAM ROUND DRESSING, GRANUFOAM SILVER DRESSING, WHITEFOAM DRESS Kci USA, Inc. | OMP |
| Nov 15, 2013 | K132741 | V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEM Kci USA, Inc. | OMP |
| Nov 13, 2013 | K122490 | KULAVAC CG Bio Co., Ltd., KR | OMP |
| Oct 23, 2013 | K132446 | RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE Smith & Nephew, Inc. | OMP |
| Sep 27, 2013 | K132252 | EXTRICARE 100CC/ 250CC/ 400CC CANISTERS Devon Medical | OMP |
| Sep 17, 2013 | K121817 | VCARE A IVT Medical, Ltd., IL | OMP |
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