ClearanceBrief
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
Aug 13, 2013K131464EXTRICARE NPWT FOOT DRESSING
Devon Medical, Inc.
OMP
Apr 4, 2013K123507KCI NPWT GAUZE DRESSING
Kci USA, Inc.
OMP
Feb 12, 2013K113236FORYOU NPWT DEVICE
Foryou Medical Electronics Co, Ltd.
OMP
Jan 17, 2013K122132AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM
Molnlycke Health Care
OMP
Jan 15, 2013K123878PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING
Kci USA, Inc. (Kinetic Concepts, Inc.)
OMP
Nov 9, 2012K112853VOLTERA POWERED SUCTION PUMP
Suzric Enterprise Co., Ltd., TW
OMP
Oct 11, 2012K121883PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT
Kci USA, Inc. (Kinetic Concepts, Inc.)
OMP
Oct 5, 2012K120499ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM
Kci USA, Inc. (Kinetic Concepts, Inc.)
OMP
Oct 1, 2012K113678INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM
Medela AG
OMP
Aug 30, 2012K113291SIMEX NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMPS SERIES: SIM-EX200 AND SIM-EX300
Simex Medizintechnik GmbH, DE
OMP
Jul 30, 2012K113199KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT
Kevo Medical Supplies
OMP
Jun 29, 2012K111949AC WOUND TREATMENT SYSTEM
Nanovibronix, Inc.
OMP
May 31, 2012K120033ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT
Kci USA, Inc.
OMP
May 16, 2012K112127PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM
Smith & Nephew, Inc.
OMP
Feb 10, 2012K110078EXTRICARE
Devon Medical Products, Inc.
OMP
Jan 5, 2012K112458PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEM
Medica-Rents Co., Ltd.
OMP
Dec 15, 2011K111170PICO
Smith & Nephew, Inc.
OMP
Aug 8, 2011K111333ANTLIA III WOUND TREATMENT SYSTEM
Innovative Therapies, Inc.
OMP
Jul 21, 2011K111280V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT
Kci USA, Inc.
OMP
Jun 22, 2011K110647RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS
Smith & Nephew, Inc.
OMP
Mar 14, 2011K103156V.A.C. VERAFLO CLEANSE DRESSING SYSTEM
Kci USA, Inc. (Kinetic Concepts, Inc.)
OMP
Jan 24, 2011K100823WOUND PRO APEX
Accuro Medical Products, LLC
OMP
Dec 15, 2010K102956V.A.C. GRANUFOAM SILVER SMALL DRESSING; V.A.C. GRANUFOAM SILVER MEDIUM DRESSING; V.A.C. GRANUFOAM SILVER LARGE DRESSING
Kci USA, Inc. (Kinetic Concepts, Inc.)
OMP
Sep 17, 2010K100657V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY SYSTEM) MODEL V.A.C. ULTA THERAPY UNIT MODEL U
Kci USA, Inc. (Kinetic Concepts, Inc.)
OMP
Aug 6, 2010K102001MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY
Smith & Nephew, Inc.
OMP
Jun 29, 2010K092992A4-XLR8 FOAM DRESSING
Genadyne Biotechnologies, Inc.
OMP
Jun 11, 2010K100821PREVENA INCISION MANAGEMENT SYSTEM
Kci USA, Inc.
OMP
Mar 10, 2010K093526V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM D
Kci USA, Inc. (Kinetic Concepts, Inc.)
OMP
Dec 29, 2009K091585VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100
Kci USA, Inc.
OMP
Nov 25, 2009K093564SVED WOUND TREATMENT SYSTEM
Innovative Therapies, Inc.
OMP
Aug 25, 2009K090258VENTURI NPWT V. II ADVANCED VACUUM SYSTEM
Talley Medical
OMP
Jul 9, 2009K091470RANASYS EZ NEGATIVE PRESSURE WOUND THERAPY SYSTEM, MODEL 66800059
Smith & Nephew, Inc.
OMP
Apr 29, 2009K090638GENADYNE A4-XLR8 WOUND VACUUM SYSTEM
Genadyne Biotechnologies, Inc.
OMP
Apr 2, 2009K090130ATMOS S041 WOUND
Atmos, Inc.
OMP
Mar 4, 2009K083357OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CANISTER, MODEL 370510
Kci USA, Inc.
OMP
Feb 25, 2009K083375RENASYS GO NEGATIVE PRESSURE WOUND THERAPY
Smith & Nephew, Inc.
OMP
Dec 18, 2008K082676GENADYNE A4 WOUND VACUUM SYSTEM
Genadyne Biotechnologies, Inc.
OMP
Nov 25, 2008K082415PRODIGY NPWT SYSTEM MODEL PRODIGY 800V
Premco Medical Systems, Inc.
OMP
Nov 14, 2008K082211RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS
Smith & Nephew, Inc.
OMP
Oct 9, 2008K080275NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM
Iasis Medical, Inc.
OMP
Oct 8, 2008K082311EXSUDEX WOUND DRAINAGE PUMP
The Medical Company, NL
OMP
Sep 5, 2008K082426RENASYS EZ
Smith & Nephew, Inc.
OMP
Jul 24, 2008K080357MEDELA INVIA WOUND THERAPY
Medela AG, CH
OMP
Jul 15, 2008K080897VENTURI NEGATIVE PRESSURE WOUND THERAPY SYSTEM
Talley Medical
OMP
Jun 7, 2007K063740V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766
Kci USA, Inc.
OMP
Jun 7, 2007K063692V.A.C. THERAPY SYSTEMS-ACTI V.A.C. THERAPY UNIT MODEL# 340000
Kci USA, Inc.
OMP
May 24, 2007K071301ANTLIA I WOUND IRRIGATION SYSTEM
Innovative Therapies, Inc.
OMP
Apr 13, 2007K070904ANTLIA II SUCTION PUMP SYSTEM
Innovative Therapies, Inc.
OMP
Feb 5, 2007K061919VERSATILE 1 EZCARE WOUND VACUUM SYSTEM
Blue Sky Medical Group Incorporated
OMP
Jan 25, 2007K063590V.A.C. FREEDOM CANISTER, MODEL M6275421; V.A.C. ATS CANISTER, MODELS K6275422, M6275423
Kci USA, Inc.
OMP

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