• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
1 to 291 of 291 Results
ProductCode: JOW Decision Date To: 05/25/2018
Results per Page
New Search  
Export all 291 Records to ExcelExport to Excel | Download Files | More About 510(k)
Device Name
Sort by Device Name [A-Z]
Sort by Device Name [Z-A]
Sort by Applicant [A-Z]
Sort by Applicant [Z-A]
Sort by 510(k) Number [0-9]
Sort by 510(k) Number [9-0]
Sort by Decision Date [0-9]
Sort by Decision Date [9-0]
medi pneumatic compression system (pcs) medi usa, lp K183631 01/25/2019
pulse rx 2.0, pulse pro rx 2.0 normatec industries, lp K183328 12/21/2018
devon 52 sequential compression device devon medical products (jiangsu) ltd K182150 12/18/2018
radial medical compression system radial medical, inc. K181651 10/12/2018
vascuease ic-1200-wh bio compression systems, inc. K180248 08/07/2018
vesoflow lite dvt compression device caremed supply, inc. K181217 08/05/2018
therm-x pro, therm-x at, therm-x pro ath zenith technical innovations K181149 08/03/2018
venera 508 deep vein thrombosis (dvt) pr suzhou minhua medical apparatus supplies K180389 06/29/2018
airos 6 sequential compression device airos medical, inc. K172770 06/22/2018
airos 8 sequential compression device airos medical, inc. K172779 06/22/2018
angio-press lite dvt compression device pegasus medical supply, inc. K173012 05/10/2018
flowtron dvt5 small calf garment getinge (suzhou) co., ltd. K172103 03/02/2018
devon 24r deep vein thrombosis (dvt) pre devon medical products (jiangsu) ltd. K173528 02/06/2018
devon 51 devon medical products (jiangsu) ltd. K172030 11/27/2017
phlebo press dvt model mego afek ac ltd. K172277 11/03/2017
medline hemo-force dvt compression sleev medline industries, inc. K170415 09/08/2017
sequential circulator sc-2004fc-oc bio compression systems, inc. K171793 08/17/2017
devon 24 devon medical products (jiangsu) ltd. K170814 07/11/2017
lympha press optimal plus mego afek ac ltd. K170658 05/31/2017
flexitouch system tactile systems technology, inc (dba tac K170216 05/26/2017
rf1400 active compression wrap recovery force llc K162481 02/16/2017
reprocessed kendall scd express compress covidien K163620 01/19/2017
reprocessed kendall scd express foot cuf covidien K163055 12/23/2016
intermittent pneumatic compression syste daesung maref co., ltd K160180 11/03/2016
flexitouch system tactile systems technology inc (dba tact K153311 09/14/2016
reprocessed compression garments covidien K161105 08/18/2016
activecare home medical compression systems (dbn) ltd. K160431 07/13/2016
normatec pcd-t and pcd-b normatec industries, lp K161346 06/15/2016
cirona 6400 devon medical products K161209 05/31/2016
venous assist system daesung maref co., ltd. K150980 05/12/2016
hydroven 12, hydroven 12 garments huntleigh healthcare ltd K152228 04/04/2016
plasmaflow manamed, inc K160318 04/01/2016
pulseflowdf pulseflow technologies K150806 12/16/2015
alp vasqcare take home system currie medical specialties, inc. K151158 12/10/2015
cirona 6300 disposable deep vein thrombo devon medical products K151189 09/18/2015
sequential circulator sc-2008-oc, sequen bio compression systems, inc. K150953 07/16/2015
activecare+sft;activecare+sft homecare, medical compression system (dbn) ltd. K151377 07/16/2015
angio-press dvt compression device model pegasus medical supply, inc. K143202 07/07/2015
flowtron acs900 getinge (suzhou) co., ltd K143438 06/23/2015
entré model pd08-u tactile systems technology inc K143185 05/07/2015
currie medical alp pediatric calf compre currie medical specialties, inc. K143317 01/20/2015
medline renewal reprocessed compression surgical instrument service and savings K143166 01/16/2015
phlebo press dvt 603 mego afek ac ltd. K142772 12/16/2014
vesoflow plus dvt compression device caremed supply, inc. K141064 12/04/2014
activecare+sft; activecare+sft homecare medical compressions system (dbn) ltd. K142728 12/04/2014
intermittent pneumatic compression devic wuhan landing medical hi-tech ltd K141390 11/18/2014
model sc-3004-dl sequential circulator, bio compression systems, inc. K142640 11/06/2014
reprocessed kendall scd express compress covidien K140813 07/15/2014
pulstar logix pump albahealth llc K141609 07/15/2014
devon cirona 6200 dvt devon medical K141578 06/27/2014
novopress milka, llc K131416 06/23/2014
tripleplay pro wildcat medical, inc. K141360 06/12/2014
pcd 737a mego afek ac ltd K140642 06/10/2014
activecare dvt, activecare+sft, and acti medical compression systems (dbn) ltd. K140755 05/08/2014
currie medical reprocessed alp calf/thig currie medical specialties, inc. K140092 04/16/2014
flowtron acs800 pump and tri pulse garme arjohuntleigh polska sp z.o.o. K133119 02/28/2014
vena pro innovamed health, llc K133274 02/12/2014
artassist and venassist aci medical, llc K131146 02/10/2014
wright gradient 52 - torso wright therapy products, inc K131387 11/20/2013
petite basic system 701 elt mego afek ac ltd K131420 11/01/2013
kendall scd 700 sequential compression c covidien K132360 08/27/2013
intermittent pneumatic compression devic dalian labtek science & development co., K123830 08/16/2013
ic-1545-dl multi flo dvt combo intermitt bio compression systems, inc. K131306 07/22/2013
vasculaire compression system, vasculair venous health systems, inc. K131046 07/18/2013
bioarterial plus arterial blood flow enh bio compression systems, inc. K131327 07/18/2013
cirona dvt foot garment devon medical inc. K131743 07/01/2013
aircast venaflow elite system djo, llc K130722 06/20/2013
actitouch act-adaptive compression thera tactile systems technology inc K131193 06/18/2013
dvtcare ca5 ossur americas inc K130174 05/02/2013
devon cirona 6100 dvt devon medical inc. K130571 04/09/2013
circuflow 5150 devon medical inc. K123959 02/28/2013
vpulse cothera, llc K122640 02/22/2013
circuflow 5208 sequential compression de devon medical inc. K123647 02/14/2013
pulstar logix intermittent pneumatic com albahealth, l.l.c. K123308 02/08/2013
vasopouse deep vein thrombosis compressi caremed supply, inc. K122873 01/15/2013
vasculaire compression system model fls- venous health systems, inc. K122609 12/21/2012
flowtron foot garment-regular-sterile fl arjohuntleigh polska sp z.o.o. K122330 12/07/2012
practical compression device (pcd) 901a& mego afek ac ltd K121962 10/19/2012
aircast venaflow elite system djo, llc K122499 10/18/2012
vasopress dvt leg garments (sterile) vas compression therapy concepts K122179 08/20/2012
a-v foot pump dalian labtek science & development co., K121718 08/17/2012
compression care flight medical minds llc K121376 07/24/2012
renu medical reprocessed aircast venaflo renu medical, inc. K121145 06/12/2012
kendall scd 700 sequential compression c covidien K120944 05/31/2012
copression systems (models cmp-001 and c novitas medical, llc K121001 04/17/2012
flexitouch system tactile systems technology inc K120972 04/13/2012
activecare dvt activecare+sft medical compression systems (d.b.n.) ltd K113525 01/31/2012
the venous assist system daesung maref co., ltd. K112677 01/13/2012
normatec mvp normatec industries, lp K112890 01/04/2012
recovery+ model ps 511, dvtherapy model joy long K111748 11/23/2011
vasopress reprocessed dvt leg / foot gar compression therapy concepts, inc. K112838 11/10/2011
powerpress unit hanuri distribution, inc K110276 11/09/2011
aviafit flowmedic ltd. K111720 09/16/2011
alp 501 rb pump system currie medical specialties, inc. K112311 09/01/2011
vesoflow caremed supply, inc. K110977 08/25/2011
activecare sft medical compression systems (dbn) ltd. K110159 05/12/2011
venodyne v810 microtek medical, inc. K110358 05/05/2011
vasculaire compression system venous health systems, inc. K103113 02/02/2011
tripleplay-vt vascular therapy system wildcat medical inc K103187 01/26/2011
vascopress sequential dvt pump compression therapy concepts K102940 01/20/2011
vascucomp thermotek, inc. K103247 12/10/2010
wmi reprocessed dvt wrap, wmi reprocesse wmi enterprises llc K101035 10/29/2010
augease vascular augmentation device augdvt llc K101355 10/26/2010
vasograd dvt compression garment compression therapy concepts K102732 10/19/2010
kendall scd 700 sequential compression c covidien llc K102737 10/19/2010
arterioflow model 7500 sequential compre devon medical inc. K102582 10/07/2010
wmi dvt wrap, wmi thermal wrap model: d- wmi enterprises llc K100969 09/20/2010
midwest reprocessing center reprocessed midwest reprocessing center llc K101330 08/27/2010
midwest reprocessing center reprocessed midwest reprocessing center llc K101702 08/27/2010
vasopress supreme mini model vp500dm compression therapy concepts, inc. K101915 08/06/2010
1-m graduated compression anti-embolism i-ming sanitary materials co., ltd. K092892 08/03/2010
reprocessed compression sleeves ascent healthcare solutions K100909 07/23/2010
reprocessed restep compression sleeves ascent heatlhcare solutions K101087 07/16/2010
circuflow 5200 sequential compression de devon medical inc. K101523 06/17/2010
lympha press 201max, model 201max mego afek ac ltd K100677 05/20/2010
comfysleeve 1-75 and lymphapod sleeves, mego afek ac ltd K100521 05/14/2010
kendall scd sequential compression comfo covidien K100306 05/04/2010
circuflow 5100 sequential compression de devon medical inc. K100446 03/05/2010
renu medical vasopress calf , thigh garm renu medical, inc. K093658 01/14/2010
aircast venaflow elite system djo, llc K091700 07/09/2009
restep dvy system, model rsp-101 stortford medical llc K090308 05/01/2009
hygia health services reprocessed compre hygia health services, inc. K090074 04/22/2009
lympha press optimal, model# 1201ap mego afek ac ltd K082149 10/06/2008
university health care processed alterna university of utah hospitals and clinics K080551 05/28/2008
amadeus adaptive compression therapy convatec K071763 03/07/2008
venowave models vw5-6, vw5-10, vw5-20 an venowave, inc. K073028 03/07/2008
phlebopress model 601a compression thera mego afek K072372 11/21/2007
ctu676 device compression technologies unlimited, inc. K073013 11/21/2007
bioarterial plus, arterial blood flow en bio compression systems, inc. K072666 11/05/2007
aviafit pulsating legband flowmedic ltd. K071744 09/25/2007
cirqlator intrathoracic pressure regulat advanced circulatory systems, inc. K070490 06/20/2007
wright model 51 and 52 sequential compre wright linear pump, inc. K071040 05/22/2007
ipc-boot c-boot ltd. K070324 05/03/2007
vasopress dvt system, model vp500d compression therapy concepts, inc. K061814 11/30/2006
flexitouch system tactile systems technology inc K062818 10/06/2006
scd garment, model vp530 compression therapy concepts, inc. K061967 09/25/2006
nanotherm, vascutherm and prothermo the thermotek, inc. K061866 08/22/2006
model multi-flo ic-1545-kt/-f intermitte bio compression systems, inc. K061857 08/01/2006
dvtcare ca5 doctors orders K061125 05/23/2006
suretek medical reprocessed compression suretek medical K052691 05/17/2006
proact with gel or proact 1 proact inc. K052243 04/12/2006
renu medical reprocessed alp 1 calf garm renu medical, inc. K051227 04/07/2006
vanguard reprocessed compression garment alliance medical, inc. K051438 04/04/2006
activecare ++ system medical compression systems (dbn) ltd. K060146 03/08/2006
reprocessed compression sleeves alliance medical corp. K060049 02/24/2006
alliance medical corporation reprocessed alliance medical corp. K060091 02/17/2006
hygia health services reprocessed kendal hygia health services, inc. K053575 02/15/2006
reprocessed compression sleeves alliance medical corp. K053316 02/13/2006
pbs model 701a compression therapy devic mego afek K060220 02/09/2006
kendall scd sleeves (extra large knee, e tyco healthcare/kendall K051805 10/13/2005
gs-128 gradient compression system medmark technologies, llc K050584 03/22/2005
model sc-3008 sequential circulator bio compression systems, inc. K043423 02/01/2005
flowmedic, model 220 flowmedic (israel) ltd K042217 01/12/2005
c-boot c-boot ltd. K041659 10/28/2004
kendall scd express kambia thigh length tyco healthcare K040649 07/15/2004
scd express portable compression system tyco healthcare/kendall K040511 06/28/2004
lifestyle circulatory enhancer advanced circulatory systems, inc. K040084 04/07/2004
jsa's reprocessed compression sleeve dev jack speer and assoc., inc. K040065 03/29/2004
wfsi's reprocessed compression sleeve de wheaton franciscan services inc., supply K033615 02/13/2004
jsa reprocessed compression sleeve devic jack speer and assoc., inc. K031722 11/25/2003
modification to resqpod circulatory enha advanced circulatory systems, inc. K033401 11/20/2003
renu medical reporcessed compressible li renu medical, inc. K031559 11/12/2003
uuhc reprocessed compression sleeve devi university of utah hospitals and clinics K031189 10/16/2003
resqpod circulatory enhancer cprx llc K022906 06/11/2003
arterialflow system, model 32a aircast, inc. K024019 06/03/2003
reprocessed compression sleeves alliance medical corp. K024087 03/11/2003
reprocessed compression sleeves alliance medical corp. K024074 03/07/2003
travelair portable compression system dynamic air, inc. K022340 02/19/2003
venaflow reusable calf aircell, model 30 aircast, inc. K023800 02/10/2003
reprocessed compression sleeve alliance medical, inc. K021654 02/05/2003
hygia health services reprocessed novame hygia health services, inc. K021509 12/24/2002
wizair compression system medical compression systems (d.b.n.) ltd K023573 11/21/2002
reprocesses used disposable sequential c medical device services K022753 11/14/2002
dvt60 huntleigh healthcare, inc. K022786 09/19/2002
reprocessed venodyne sequential compress adven medical K021528 08/21/2002
body force, model bt 6000 composites solutions, inc. K020211 06/28/2002
aircast, model #3011 millenium reprocessing services, inc. K013297 06/14/2002
reprocessed compression limb sleeves surgical instruments service and savings K012658 05/14/2002
compressible limb sleeve medical device services, inc. K012979 05/08/2002
kendall, sequential compression device; medical instruments technology, inc. K012614 05/01/2002
hygia health services reprocessed nutech hygia health services, inc. K012650 04/12/2002
hygia health services reprocessed huntle hygia health services, inc. K012651 04/12/2002
hygia health services reprocessed huntle hygia health services, inc. K012654 04/12/2002
hygia health services reprocessed nutech hygia health services, inc. K012657 04/12/2002
hygia health services reprocessed nu tec hygia health services, inc. K012956 04/11/2002
hygia health service reprocessed kendall hygia health services, inc. K012417 04/08/2002
wizair dvt medical compression systems (dbn) ltd. K012994 03/27/2002
flowtron universal, model ac600 huntleigh healthcare, inc. K010744 03/26/2002
reprocessed used disposable sequential c adven medical K012675 02/12/2002
sterilmed reprocessed compression sleeve sterilmed, inc. K012597 02/11/2002
clearmedical/aircast venaflow calf cuff, clear medical, inc. K012601 02/06/2002
clearmedical/kendall knee-high scd sleev clear medical, inc. K012606 02/06/2002
clearmedical/novamedix avi foot cover, p clear medical, inc. K012612 02/06/2002
clearmedical/huntleigh foot garments; mo clear medical, inc. K012616 02/06/2002
clearmedical/hentleigh deep vein thrombo clear medical, inc. K012621 02/06/2002
normatec pcd normatec, inc. K013436 12/21/2001
lympha press plus device mego afek K013331 11/30/2001
compressible limb sleeve alliance medical corp. K011192 11/26/2001
venodyne dvt advantage plus microtek medical, inc. K011318 10/25/2001
sterilmed intermittent compression syste sterilmed, inc. K003857 10/18/2001
vanguard reprocessed compression garment vanguard medical concepts, inc. K012403 10/17/2001
sts range , models sts20,sts30,sts40 huntleigh healthcare, inc. K012008 09/21/2001
proact 1 proact co. K003909 06/13/2001
vaso press dvt foot garment #vp 520 britt corp., inc. K003828 05/18/2001
sentech medical express compression syst sentech medical systems, inc. K003701 04/05/2001
phlebopump, model 1000 prevent products, inc. K003284 01/17/2001
venodyne dvt advantage model 610 microtek medical, inc. K001802 01/09/2001
wizair compression system medical compression systems (d.b.n.) ltd K002287 08/25/2000
vaso press dvt system, models vp500, vp5 britt corp., inc. K991038 06/22/2000
proair 3000 compression system medical compression systems (d.b.n.) ltd K993758 05/19/2000
healthcare service and supply alp altern healthcare service and supply K000303 05/16/2000
ctc dvt-1 calf garment, model dvt-1 compression therapy concepts, inc. K000147 04/13/2000
venaflow system, model 30a aircast, inc. K992454 01/13/2000
kendall model 7325 scd response compress the kendall company, l.p. K992079 09/29/1999
walkcare p200 system a. stein - regulatory affairs consulting K973592 05/20/1999
trinity ii single chamber dvt pump delphi consulting group K983680 04/28/1999
cowboy xv kci new technologies, inc. K981311 04/23/1999
vaso press system britt corp., inc. K974393 03/19/1999
rtm dvt prosoft cuff model number ps100 r.t. medical services, inc. K981643 12/14/1998
d903 avant adult hollow fiber oxygenator dideco s.p.a. K980600 08/12/1998
biomedical horizons inc. compression pum biomedical horizons, inc. K971892 08/05/1998
jobst athrombic pump system 2600 jobst a beiersdorf co. K980456 05/05/1998
healthcare service and supply alp altern healthcare service and supply K974318 02/13/1998
huntleigh fp5000 system model fp5000 huntleigh healthcare, inc. K965153 01/26/1998
jobst athrombic pump/sleeve jobst a beiersdorf co. K970922 01/13/1998
trinity dvt system delphi consulting group K963957 11/04/1997
aircast vena flow sterile disposable cuf aircast, inc. K964238 09/08/1997
trinity sleeves, huntleigh pump compatib delphi consulting group K970014 08/06/1997
a-v impulse system model 6060 powell,goldstein,frazer & murphy K964425 07/28/1997
healthcare service and supply pva (pneum healthcare service and supply K964188 05/06/1997
aircast venaflow system (modification) aircast, inc. K961676 03/28/1997
sof. press epc 51 system gaymar industries, inc. K963067 01/28/1997
jobst athrombic pump system 2100 jobst a beiersdorf co. K963929 01/27/1997
model 90022 rolling stand augustine medical, inc. K963672 01/06/1997
alba health pas wrap system alba-waldensian, inc. K961405 12/26/1996
wlp sequential version model wlp solo vi wright linear pump, inc. K961292 11/06/1996
wlp gradient sequential version/wlp prol wright linear pump, inc. K961797 11/06/1996
wlp single-segment version wlp solo vii wright linear pump, inc. K961891 11/06/1996
eureduc pneumatic drainage system eureduc K954788 10/28/1996
bio boost bio compression systems, inc. K961426 10/28/1996
flowtron excel pump hne healthcare, inc. K961166 10/11/1996
eureduc pneumatic drainage system model eureduc K960902 09/26/1996
ankle calf exerciser phlebopump prevent products, inc. K952975 09/25/1996
healthcare service & supply pump alp 501 healthcare service and supply K955853 06/25/1996
m.i.c. v.v.t. healthcare technologies, inc. K950967 05/08/1996
redox kinetic concepts, inc. K953850 03/04/1996
art-assist model aa-1000 aci medical, inc. K942530 02/28/1996
trinity sleeve(s) delphi consulting group K954489 02/22/1996
a-v impulse system model 6060 novamedix ltd. K953648 02/12/1996
a-v impulse system model 6060 novamedix ltd. K951683 10/26/1995
airperfect 1000 (single-user system), ai digital air corp. K951684 10/06/1995
cowboy x kinetic concepts, inc. K944567 06/21/1995
presssion s iii chattanooga group, inc. K942796 03/24/1995
kendall model 6325 scd sequel compressio the kendal co. K942664 01/17/1995
thera-flow gradient sequential pump meds systems, inc. K943392 12/30/1994
act-one advanced compression technology ndm acquisition corp. K943287 12/27/1994
jobst athrombic pump - system 2500 jobst institute, inc. K934639 02/09/1994
aircast edemaflow system aircast, inc. K933977 12/07/1993
intermittent compression system model 50 advanced instruments, inc. K930526 11/18/1993
aircast venaflow system aircast, inc. K932900 10/25/1993
scd(r) controller kendall healthcare products co. div.of t K933259 09/13/1993
kendall t.e.d./scd sequential compressio kendall healthcare products co. div.of t K932835 08/06/1993
cowboy iii kinetic concepts, inc. K932215 07/21/1993
plexus pulser i, plexus pulser ii dobre, inc. K924891 06/07/1993
calf garment dvt10(s) compressible limb huntleigh healthcare, inc. K925717 05/07/1993
presssion, sequential chattanooga group, inc. K921608 12/30/1992
cowboy ii kinetic concepts, inc. K920308 08/24/1992
jobst extremity pump system 7500 jobst institute, inc. K921562 06/22/1992
a-v impulse system novamedix ltd. K914461 04/15/1992
cowboy kinetic concepts, inc. K913611 01/13/1992
pulsatile anti-embolism sys.pump baxter healthcare corp. K911853 07/22/1991
flowplus ac330 pump garments huntleigh technology, inc. K910188 05/28/1991
venapulse models vp-25 and vp-50 aci medical, inc. K903894 04/03/1991
zoex antishock trousers zoex corp. K904267 03/18/1991
jobst athrombic pump(r) system 2000 jobst institute, inc. K895732 01/26/1990
scd knee immobilizer kendall healthcare products co. div.of t K895278 11/30/1989
kendall scd therapeutic system kendall healthcare products co. div.of t K890938 05/19/1989
flowtron dvt system ac500 pump, l501 gar huntleigh technology, inc. K881632 09/26/1988
jobst extremity pump(r) system 7500 jobst institute, inc. K882683 09/20/1988
anti-shock trousers simulaids, inc. K873997 12/15/1987
modified model 5320 t.e.d. compression l the kendal co. K863581 10/31/1986
medo medomer mbf-100 ii medo u.s.a., inc. K841235 11/19/1984
linear pump #4370975 wright linear pump, inc. K830577 05/25/1983
the soft pedal habco products, inc. K821696 07/14/1982
lympha press mego afek K810338 10/20/1981
dvt prevention sys. mbe 22 pressure u. med-bio engineering, inc. K800337 03/25/1980
3m brand total leg compression tlc sys. 3m company K791894 11/16/1979
t.e.d. sequential compression sleeves kendall research center K781357 09/20/1978
sequential cuff inflation device medasonics, inc. K781358 09/20/1978
pas anti-embolism system hamilton industries, inc. K770956 09/12/1977
sequential pressure cuff gaymar industries, inc. K771083 07/21/1977