FDA.reportPublic FDA data

RENU MEDICAL, INC.

Matched from indexed company URL: REN Ltd

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30345203003350313RENU MEDICAL, INC.1N2026-01-015900 36th Ave W Ste 100 EVERETT WA US 98203
30078425553007842555Renee Rees1N2026-01-0135 Constitution Drive, Suite 1D Bedford NH US 03110
30081907093008190709Renfro LLC1N2026-01-014405 Michigan Avenue Rd NE Cleveland TN US 37323
30088409593008840959Renee Rees1N2026-01-0135 Constitution Drive, Suite 1D Bedford NH US 03110
30091088883009108888RENISHAW MAYFIELD1N2026-01-0131 rue Ampere Chassieu Rhone FR 69680
30091182643009118264Renee Rees1N2026-01-0135 Constitution Drive, Suite 1D Bedford NH US 03110
30092182713009218271Renee Rees1N2026-01-0135 Constitution Drive, Suite 1D Bedford NH US 03110
30092330383009233038Renee Rees1N2026-01-0135 Constitution Drive, Suite 1D Bedford NH US 03110
30094966433009496643Renee Rees1N2026-01-0135 Constitution Drive, Suite 1D Bedford NH US 03110
30112796743011279674RENOVORX, INC.1N2026-01-012570 W El Camino Suite 320 Mountain View CA US 94040
30122543433012254343RENISHAW HEALTHCARE INC1Y2026-01-011001 wesemann dr. West Dundee IL US 60118
30135887403013588740Renee Zamani1N2026-01-012196 3rd Ave # 1004 New York NY US 10035
30139560813013956081RENEE'S READERS1N2026-01-0118 Sandusky Road New City NY US 10956
30140235453014023545RENOVO, INC.1N2026-01-01340 SW COLUMBIA ST Bend OR US 97702
30187399123018739912RENALYTIXAI1N2026-01-0130-02 48th Avenue Suite 150 Long Island City NY US 11101
30187990473018799047RENEWMEDICAL CO., LTD.1N2026-01-0128-7, Jeongju-ro Bucheon-si, Gyeonggi-do KR 14532
30223175913022317591RENERVE LTD1N2026-01-01L 10 99 Queen Street Melbourne Victoria AU 3000
30270984023027098402RENATA MEDICAL1N2026-01-014675 Macarthur Ct Ste 1150 Newport Beach CA US 92660
30272418263027241826RENAL CARE DIALYSIS SOLUTIONS, S.A. DE C.V.1N2026-01-01Carretera a los Cues K.M. 2.2, Lote 23 Bodegas 5 y 6. El Marques Queretaro MX 76246
30279784123027978412RENOLIT HANSEN PACKAGING TECH. (BJ) LTD.1N2026-01-01NO.22 Yanqi Street, Huairou Economic Development District Beijing CN 101407
30429283503042928350Rene Balzano1N2026-01-01610 E Zack St Ste 110-3058 Tampa FL US 33602
00Renlin Li5N2020-04-2511300 Rockville Pike, Suite 715, Rockville Rockville MD US 20852
96150203002739972Renee Bennett1N2020-04-253050 East Hillcrest Drive Thousand Oaks CA US 91362
96163793003572251Rene van de Zande1N2020-04-252500 Bee Cave Road Bldg 1, Suite 300 Austin TX US 78746
97104523000157372Rene van de Zande1N2020-04-252500 Bee Cave Road Bldg 1, Suite 300 Austin TX US 78746

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3311751236501368P240003Minima Stent SystemPNF2024-08-28
201211246174566K990284BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLEDXF2001-02-01
201211246690306K972846BMC RF CANNULAGXI1998-07-17
1336451711364071K250496Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White)LZA2025-07-07
3470191058829504K242607ScanDiags Ortho L-Spine MR-QQIH2025-02-21
1309571316948092K222815Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and FentanylLZA2022-12-04
1352951993909595K222815Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and FentanylLZA2022-12-04
1352951016751991K222074Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet Blue), Powder Free Latex Examination GlovesLZA2022-10-17
1074312003350353K222074Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet Blue), Powder Free Latex Examination GlovesLZA2022-10-17
3165861204198756K221652NIKKICARTKPO2023-03-03
1352951300019120K212998Powder Free Nitrile Examination Gloves (White, Blue and Black)LZA2022-02-19
1764481152227410K212324RenovoCathMJN2021-08-23
592421040042785K203847Reprocessed Tri Pulse Compression GarmentJOW2021-05-07
3043881626090135K202234NervAlign Nerve CuffJXI2022-02-10
1764481699725477K191606RenovoCathMJN2019-08-07
201211886516507K190688VersaCross Steerable Sheath, VersaCross Transseptal DilatorDYB2019-04-17
201211588279577K183655VersaCross Transseptal SheathDYB2019-05-20
201212033267303K183649Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology CableDRF2019-06-07
201211575676094K183632Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology CableDRF2019-06-07
1309571143182067K182640Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue)LZA2019-04-12
1229881145548872K182640Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue)LZA2019-04-12
201212047861354K182064ExpanSure Transseptal Dilation SystemDRE2019-03-21
201211706800453K181864Polaris RF Ablation SystemGXD2019-01-02
1732761973782716K181706neuromate Gen IIIHAW2018-07-26
2114272030138206K173741Reprocessed ArthoCare Ablation WandNUJ2018-03-05
2114271143477685K173740Reprocessed DePuy Mitek Ablation WandNUJ2018-03-19
2114271178649201K172647Reprocessed ArthroCare ENT CoblatorNUJ2018-02-21
2114271352726919K172097Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar SleevesNLM2017-10-06
2114271422744499K172093Reprocessed Covidien TrocarNLM2017-10-05
2114271579470534K172092Reprocessed Shavers/BursHRX2017-10-04
201211775706431K161949OsteoCool V-3 RF Ablation SystemGEI2017-01-31
201211853499101K161878PORTAGE SystemHRX2016-09-26
201211048274931K152057OsteoCool V-3 RF Ablation SystemGEI2015-11-24
201211210231142K151009Nexus SutureGAT2015-08-18
201211895455292K150709ProTrack RF Anchor WireDXF2015-06-17
1764481191421130K141175RENOVOCATH RC120MJN2014-10-24
1732761577191138K132755NEUROMATE FRAMELESS GEN IIHAW2014-04-29
201211322039036K132374BAYLIS MEDICAL RF PERFORATION PROBE V2.0GEI2013-08-30
201211993750467K122926SUREFLEX STEERABLE GUIDING SHEATH KITDYB2013-01-24
201211966514212K122278BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATORGEI2012-11-07
592421323679103K121145RENU MEDICAL REPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU MEDICAL REPROCESSED AIRCAST VENAFLOW THIGH GARMEJOW2012-06-12
1352951066229750K112222ALCATRON AND / OR MULTIPLE BRANDLYZ2011-10-27
1336451548787294K111857SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREELYZ2011-09-21
592421728001450K111773RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATENLF2011-11-16
1309571303738268K111297SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)LYZ2011-06-16
201211575745872K111288ANCHORWIRE GUIDEWIREDQX2011-08-02
1074311108729753K110621SHENGKUN CHEMICALLYZ2011-08-24
1336451941804333K110621SHENGKUN CHEMICALLYZ2011-08-24
1363041211118126K110314STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE/CLEAR(NON-COLORED)LYZ2011-05-10
201211571870056K102948TORFLEX TRANSSEPTAL GUIDING SHEATHDYB2011-04-01
1229881366750331K102337SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREELYZ2010-11-08
201211935355784K101615POWERWIRE RADIOFREQUENCY GUIDEWIREPDU2010-07-28
592421152544767K093658RENU MEDICAL VASOPRESS CALF , THIGH GARMENTS- ALL SIZESD, RENU MEDICAL VASOPRESS FOOT GARMENTSJOW2010-01-14
1074311067616166K091422NOVAPRO STRETCH VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE)LYZ2009-07-30
1074311458178969K091421NOVAPRO VINYL EXAMINATION GLOVE POWDER FREE (NON-COLORED)LYZ2009-07-23
1363041864458420K090513VINYL EXAMINATION GLOVE, POWDER FREE CLEAR (NON-COLORED)LYZ2009-05-08
592421899155459K081927RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEONLF2009-02-06
201211547153073K073326NRG TRANSSEPTAL NEEDLEDXF2008-05-28
592421701948783K072194RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25NLF2007-11-29
592421016884366K063661RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20NLF2007-05-25
592421135766100K051227RENU MEDICAL REPROCESSED ALP 1 CALF GARMENT, MODEL ALP1JOW2006-04-07
1005521332426069K050260BIORESORB MACRO PORELYC2005-07-15
592421351628016K031559RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVESJOW2003-11-12
201211282126343K023334BMC CATHETER CONNECTOR CABLE, MODEL RFP-101DSA2002-12-31
201211902877639K014075BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145DQX2002-03-07
201211240603183K013904BMC RADIO FREQUENCY PERFORATION GENERATOR, MODELS RFP-100-115 AND RFP-100-230GEI2002-02-12
201211900903373K010265BAYLIS MEDICAL RF PERFORATION PROBE, MODEL RFP-265GEI2001-04-09
2916612068803454DEN200052KidneyIntelX.dkdQWZ2023-06-29
2114271009610732
2114271041288751
159691073297976
2114271089112145
592421120517088
2246811159957307
2533421163946638
2114271174879093
2114271283042776
2114271286368290
2114271300566526
2114271310257243
2114271458366982
201211478734201
2114271512021555
159691641048900
2114271656377002
159691734149868
2533421821192285
159691823200394
2246811902977881
2114271940972182
2114271949911859
592421963830973
2114271990449278
2114272001390664
2114272019111218
2114272065748036
2114271025423461
1363041059535998
1336451080417428
592421097889985
3342661267865244
2114271268274762
2114271430026738
592421458284312

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LYZ102011-10-27
LZA82025-07-07
NUJ62018-03-19
GEI62017-01-31
JOW52021-05-07
DYB42019-05-20
NLM42017-10-06
NLF42011-11-16
MJN32021-08-23
HRX32017-10-04
DXF32015-06-17
DRF22019-06-07
HAW22018-07-26
DQX22011-08-02
QIH12025-02-21
QWZ12023-06-29
KPO12023-03-03
JXI12022-02-10
DRE12019-03-21
GXD12019-01-02
GAT12015-08-18
PDU12010-07-28
LYC12005-07-15
DSA12002-12-31
GXI11998-07-17

NDC#

IC-Green

Renew Pharmaceuticals Limited

Indocyanine Green

IC-Green

Renew Pharmaceuticals Limited

Indocyanine Green

ARCTIC HEAT

Renu Laboratories, LLC

Menthol, Methyl Salicylate

EXTREME EMU

Renu Laboratories, LLC

Menthol, Methyl Salicylate

PMN#

NIKKICART

2023-03-03

Renal Care Dialysis Solutions, S.A. DE C.V.

133 records. Showing 1-40. Next

Applications#

761400

RENGENERON PHARMACEUTICALS, INC.