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214 FDA 510(k) clearances · Product code

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RecordFirmDate
RENASYS GO (K152163)Smith & Nephew, Inc.2016-09-29
RENASYS-G Gauze Dressing Kits with Soft Port (K162129)Smith & Nephew, Inc.2016-08-31
Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large (K161570)Lc Medical Concepts, Inc.2016-08-29
RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply (K153209)Smith & Nephew Medical, Ltd.2016-08-04
V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... (K160451)Kci USA, Inc. (Kinetic Concepts, Inc.)2016-06-20
Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit with Customizable Dressing, Prevena Plus Customizable Dressing 5-Pack (K153199)Kci USA, Inc.2016-02-29
Venturi Gauze Wound Care Sets with Portal Drain (K151263)Talley Group, Ltd.2016-02-19
PICO Single Use Negative Pressure Wound Therapy System (K151436)Smith & Nephew Medical, Ltd.2016-01-28
Mepiseal Soft Silicone Sealant (K152741)Molnlycke Health Care Us, LLC2016-01-22
VENTURI MiNO TG600/14 (K143004)Talley Group, Ltd.2016-01-05
FloSure Ventilation Patch (K150459)Simex Medizintechnik GmbH2016-01-05
Prevena Incision Management System with Peel & Place Dressing, Prevena Incision Management System with Customizable Dressing (K150006)Kci USA, Inc.2015-11-06
Avance Y-Connector S (K151872)Molnlycke Health Care Us, LLC2015-11-02
Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit Large (K151261)Medela AG2015-10-07
Cardinal Health NPWT PRO HC (K150124)Cardinalhealth2015-09-02
PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, (K141017)Kci USA, Inc. (Kinetic Concepts, Inc.)2015-08-20
RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing Kit with Soft Port Device (K143133)Smith & Nephew, Inc.2015-07-23
RENASYS¿ EZ PLUS Negative Pressure Wound Therapy Device (K151326)Smith & Nephew, Inc.2015-07-16
XLR8 PLUS (XLR8+) (K143726)Genadyne Biotechnologies, Inc.2015-06-19
Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set, Y-connector, Drain Adaptor, Invia Liberty Canisters (K142626)Medela AG2015-06-12
extriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 7pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 6pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 5pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 4pc (K151240)Devon Medical Products2015-06-09
Whisper Pump System (K142385)Wound RX Medical, LLC2015-05-22
XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and (K142646)Genadyne Biotechnologies, Inc.2015-04-30
RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft Port; Gauze NPWT Wound Dressing Kits with Soft Port; EZ PLUS/EZ MAX Canisters (K142979)Smith & Nephew, Inc.2015-04-29
Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home (K143016)Cardinalhealth2015-04-20
GENADYNE SPIRO FOAM DRESSING KIT (K141961)Genadyne Biotechnologies, Inc.2015-03-26
AVANCE FOAM DRESSING KITS (K141847)Molnlycke Health Care Us, LLC2015-03-26
SVED Wound Treatment System (K142916)Cardinalhealth2015-03-04
NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit (K143301)Integrated Healing Technologies2015-03-03
NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome Kit (K142956)Integrated Healing Technologies2015-02-24
extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister (K143362)Devon Medical Products2015-02-03
UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT (K133333)Blue Ocean Medical Product, LLC2014-12-31
INVIA ENDURE NEGATIVE PRESSURE WOUND THERAPY SYSTEM (K141926)Medela AG2014-12-19
NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS NPWT CANISTER 500-ML, CORK MEDICAL PRODUCT (K140022)Cork Medical Products, LLC2014-10-24
XLR8 PLUS (XLR8+) (K141437)Genadyne Biotechnologies, Inc.2014-09-19
extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam Dressing Kit (K140634)Devon Medical, Inc.2014-09-19
SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON EASY AG ANTIMICROBIAL WOUND CONTACT NEGATIV (K141033)Argentum Medical, LLC2014-09-12
EXTRICARE (K132225)Devon Medical, Inc.2014-05-15
NPWT WOUND DRESSING KIT- MEDIUM, NPWT WOUND DRESSING KIT- LARGE (K132004)Creo Quality, LLC2014-05-02
PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA INCISION MANAGEMANT SYSTEM WITH PEEL& PLACE DRES (K133232)Kci USA, Inc. (Kinetic Concepts, Inc.)2014-03-24
NOVOPORE DRESSING (K132936)Polynovo Biomaterials Pty, Ltd.2014-03-04
V.A.C. GRANUFOAM DRESSING, GRANUFOAM THIN DRESSING, GRANUFOAM ROUND DRESSING, GRANUFOAM SILVER DRESSING, WHITEFOAM DRESS (K133276)Kci USA, Inc.2013-11-19
V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (K132741)Kci USA, Inc.2013-11-15
KULAVAC (K122490)CG Bio Co., Ltd.2013-11-13
RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE (K132446)Smith & Nephew, Inc.2013-10-23
EXTRICARE 100CC/ 250CC/ 400CC CANISTERS (K132252)Devon Medical2013-09-27
VCARE A (K121817)IVT Medical, Ltd.2013-09-17
EXTRICARE NPWT FOOT DRESSING (K131464)Devon Medical, Inc.2013-08-13
KCI NPWT GAUZE DRESSING (K123507)Kci USA, Inc.2013-04-04
FORYOU NPWT DEVICE (K113236)Foryou Medical Electronics Co, Ltd.2013-02-12
AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM (K122132)Molnlycke Health Care2013-01-17
PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING (K123878)Kci USA, Inc. (Kinetic Concepts, Inc.)2013-01-15
VOLTERA POWERED SUCTION PUMP (K112853)Suzric Enterprise Co., Ltd.2012-11-09
PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT (K121883)Kci USA, Inc. (Kinetic Concepts, Inc.)2012-10-11
ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM (K120499)Kci USA, Inc. (Kinetic Concepts, Inc.)2012-10-05
INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM (K113678)Medela AG2012-10-01
SIMEX NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMPS SERIES: SIM-EX200 AND SIM-EX300 (K113291)Simex Medizintechnik GmbH2012-08-30
KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT (K113199)Kevo Medical Supplies2012-07-30
AC WOUND TREATMENT SYSTEM (K111949)Nanovibronix, Inc.2012-06-29
ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT (K120033)Kci USA, Inc.2012-05-31
PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM (K112127)Smith & Nephew, Inc.2012-05-16
EXTRICARE (K110078)Devon Medical Products, Inc.2012-02-10
PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEM (K112458)Medica-Rents Co., Ltd.2012-01-05
PICO (K111170)Smith & Nephew, Inc.2011-12-15
ANTLIA III WOUND TREATMENT SYSTEM (K111333)Innovative Therapies, Inc.2011-08-08
V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT (K111280)Kci USA, Inc.2011-07-21
RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS (K110647)Smith & Nephew, Inc.2011-06-22
V.A.C. VERAFLO CLEANSE DRESSING SYSTEM (K103156)Kci USA, Inc. (Kinetic Concepts, Inc.)2011-03-14
WOUND PRO APEX (K100823)Accuro Medical Products, LLC2011-01-24
V.A.C. GRANUFOAM SILVER SMALL DRESSING; V.A.C. GRANUFOAM SILVER MEDIUM DRESSING; V.A.C. GRANUFOAM SILVER LARGE DRESSING (K102956)Kci USA, Inc. (Kinetic Concepts, Inc.)2010-12-15
V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY SYSTEM) MODEL V.A.C. ULTA THERAPY UNIT MODEL U (K100657)Kci USA, Inc. (Kinetic Concepts, Inc.)2010-09-17
MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY (K102001)Smith & Nephew, Inc.2010-08-06
A4-XLR8 FOAM DRESSING (K092992)Genadyne Biotechnologies, Inc.2010-06-29
PREVENA INCISION MANAGEMENT SYSTEM (K100821)Kci USA, Inc.2010-06-11
V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM D (K093526)Kci USA, Inc. (Kinetic Concepts, Inc.)2010-03-10
VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100 (K091585)Kci USA, Inc.2009-12-29
SVED WOUND TREATMENT SYSTEM (K093564)Innovative Therapies, Inc.2009-11-25
VENTURI NPWT V. II ADVANCED VACUUM SYSTEM (K090258)Talley Medical2009-08-25
RANASYS EZ NEGATIVE PRESSURE WOUND THERAPY SYSTEM, MODEL 66800059 (K091470)Smith & Nephew, Inc.2009-07-09
GENADYNE A4-XLR8 WOUND VACUUM SYSTEM (K090638)Genadyne Biotechnologies, Inc.2009-04-29
ATMOS S041 WOUND (K090130)Atmos, Inc.2009-04-02
OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CANISTER, MODEL 370510 (K083357)Kci USA, Inc.2009-03-04
RENASYS GO NEGATIVE PRESSURE WOUND THERAPY (K083375)Smith & Nephew, Inc.2009-02-25
GENADYNE A4 WOUND VACUUM SYSTEM (K082676)Genadyne Biotechnologies, Inc.2008-12-18
PRODIGY NPWT SYSTEM MODEL PRODIGY 800V (K082415)Premco Medical Systems, Inc.2008-11-25
RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS (K082211)Smith & Nephew, Inc.2008-11-14
NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM (K080275)Iasis Medical, Inc.2008-10-09
EXSUDEX WOUND DRAINAGE PUMP (K082311)The Medical Company2008-10-08
RENASYS EZ (K082426)Smith & Nephew, Inc.2008-09-05
MEDELA INVIA WOUND THERAPY (K080357)Medela AG2008-07-24
VENTURI NEGATIVE PRESSURE WOUND THERAPY SYSTEM (K080897)Talley Medical2008-07-15
V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766 (K063740)Kci USA, Inc.2007-06-07
V.A.C. THERAPY SYSTEMS-ACTI V.A.C. THERAPY UNIT MODEL# 340000 (K063692)Kci USA, Inc.2007-06-07
ANTLIA I WOUND IRRIGATION SYSTEM (K071301)Innovative Therapies, Inc.2007-05-24
ANTLIA II SUCTION PUMP SYSTEM (K070904)Innovative Therapies, Inc.2007-04-13
VERSATILE 1 EZCARE WOUND VACUUM SYSTEM (K061919)Blue Sky Medical Group Incorporated2007-02-05
V.A.C. FREEDOM CANISTER, MODEL M6275421; V.A.C. ATS CANISTER, MODELS K6275422, M6275423 (K063590)Kci USA, Inc.2007-01-25
V.A.C. ATS LARGE (1000 ML) CANISTER WITH GEL, MODELS M6275093/5, M6275093/10 (K063426)Kci USA, Inc.2006-12-13
NOVASPINE POWERED SUCTION PUMP PRO-1 (K062456)Novaspine, LLC2006-10-16
V.A.C. THERAPY SYSTEM (K062227)Kci USA, Inc. (Kinetic Concepts, Inc.)2006-10-04
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