FDA.reportPublic FDA data

AVENT

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
AVENTIX MEDICAL INC5N2026-01-0123282 Mill Creek Dr Ste 350 Laguna Hills CA US 92653
96115943002806436AVENT S. de R.L. de C.V.1N2026-01-01CIRCUITO INDUSTRIAL NO.40 COLONIA OBRERA NOGALES Sonora MX CP 84048
96804253007596547Avent S. de R.L. de C.V.1N2026-01-01Ave Noruega Edificio D-1B Fraccionamiento, Rubio TIJUANA Baja California MX 22116
30121122593012112259AVENTAMED DAC1N2026-01-01Rubicon Centre Rossa Avenue Bishopstown Cork IE T12Y275
30293004493029300449AVENTUSOFT1N2026-01-013651 FAU Blvd Suite 300 Boca Raton FL US 33431
20260952026095Avent Inc (aka Avanos Medical - Irvine)1N2020-04-2543 Discovery Suite 100 Irvine CA US 92618
96804253007596547Avent S. de R.L. de C.V.1N2020-04-25Ave Noruega Edificio D-1B Fracc. Rubio TIJUANA Baja California MX 22116
30066460243006646024Avent, Inc.1N2020-04-256620 S. Memorial Place, Suite 100 Tucson AZ US 85756
30085205393008520539Avent S. de R.L. de C.V.1N2020-04-25Privada Baja California Edificio B-2 Fracc. Rubio Tijuana Baja California MX 22116

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05391528890101Solo+ TTD Cartridge - The Solo+ TTD is a single use, sterile, “all-in-one” surgical instrument that rapidly places a tympanostomy tube across the tympanic membrane of a patient. It combines the traditionally separate functions of creating a myringotomy, and positioning and placing a tympanostomy tube across the tympanic membrane. Placement of the tube provides ventilation to the middle ear space through the tympanic membrane.+353214928980john.vaughan@karlstorz.com
05391528890156Solo+ TTD Handpiece - The Solo+ TTD is a single use, sterile, “all-in-one” surgical instrument that rapidly places a tympanostomy tube across the tympanic membrane of a patient. It combines the traditionally separate functions of creating a myringotomy, and positioning and placing a tympanostomy tube across the tympanic membrane. Placement of the tube provides ventilation to the middle ear space through the tympanic membrane.+353214928980john.vaughan@karlstorz.com
05391528890163Solo+ TTD Handpiece - The Solo+ TTD is a single use, sterile, “all-in-one” surgical instrument that rapidly places a tympanostomy tube across the tympanic membrane of a patient. It combines the traditionally separate functions of creating a myringotomy, and positioning and placing a tympanostomy tube across the tympanic membrane. Placement of the tube provides ventilation to the middle ear space through the tympanic membrane.+353214928980john.vaughan@karlstorz.com
B596HT101Y2HemoTag - The HEMOTAG Device attaches to a patient's chest using standard electrodes, for 30 second, and picks up vibrational signals from the Heart.5612344040gary@aventusoft.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
346601915289421K994374SOAKER CATHETERFRN2000-03-03
346611915289421K994374SOAKER CATHETERFRN2000-03-03
48301515906826K993138BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KITKNT1999-10-20
346601436897700K992072BOLUS ACCESSORY SETFPA1999-09-15
48301102927189K991879SPRING-WOUND EPIDURAL CATHETERBSO1999-10-28
346601705130096K991513HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVOFPA1999-06-21
346611705130096K991513HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVOFPA1999-06-21
776141040505017K984502NERVE BLOCK INFUSION KITMEB1999-03-04
3000751040505017K984502NERVE BLOCK INFUSION KITMEB1999-03-04
346601295690154K984502NERVE BLOCK INFUSION KITMEB1999-03-04
346611295690154K984502NERVE BLOCK INFUSION KITMEB1999-03-04
1200521295690154K984502NERVE BLOCK INFUSION KITMEB1999-03-04
346601167044682K982946PAINBUSTER INFUSION KITMEB1998-11-18
346611167044682K982946PAINBUSTER INFUSION KITMEB1998-11-18
48301555596696K982894MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KITKNT1998-09-11
346611899270406K980987BECTON DICKINSON SYRINGEFMF1998-06-11
346601775266362K980558PAINBUSTER INFUSION SYSTEMMEB1998-05-28
346611775266362K980558PAINBUSTER INFUSION SYSTEMMEB1998-05-28
3000751374648461K972846BMC RF CANNULAGXI1998-07-17
776141712118317K970178CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEMKNT1997-07-21
3000751712118317K970178CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEMKNT1997-07-21
48301942442248K962042GLASS SYRINGEFMF1996-10-08
48301491286503K961863PARACENTESIS TRAYSLRO1996-05-28
776141046020786K954505EZ STIMKOI1996-12-10
346601623490533K954505EZ STIMKOI1996-12-10
346601260607088K944692C-SERIES HOMEPUMPFPA1995-05-02
346611260607088K944692C-SERIES HOMEPUMPFPA1995-05-02
3000751144486026K942988FILTERED EXTENSION SETSFPA1995-07-14
346611903252246K942988FILTERED EXTENSION SETSFPA1995-07-14
48301991774932K9415621ML LUER-LOK SYRINGEFMF1994-05-26
48302041213426K941464BASICS ENDOSCOPY SYSTEMOCZ1994-08-05
1200521048818763K941153EPI-SPINAL ANESTHESIA TRAYCAZ1995-05-30
48301721615606K941153EPI-SPINAL ANESTHESIA TRAYCAZ1995-05-30
776141721615606K941153EPI-SPINAL ANESTHESIA TRAYCAZ1995-05-30
3000751721615606K941153EPI-SPINAL ANESTHESIA TRAYCAZ1995-05-30
48301994272072K940431TECNADYNE 20/20 FOG INHIBITOR KITGCJ1994-04-29
48301131416427K926581MIC TRANSGASTRIC JEJUNAL TUBEKNT1994-09-28
776141731930415K926349PROBLOC INSULATED NEEDLESGXZ1993-07-29
48301424231615K924065MIC PEG TUBEKNT1994-02-17
776141424231615K924065MIC PEG TUBEKNT1994-02-17
3000751424231615K924065MIC PEG TUBEKNT1994-02-17
48301962462137K922667MIC LOW PROFILE GASTROSTOMY TUBEKNT1993-12-01
3000751962462137K922667MIC LOW PROFILE GASTROSTOMY TUBEKNT1993-12-01
48301882648403K921652MIC TRANSGASTRIC JEJUNAL FEEDING TUBE KITKNT1994-05-02
48301545846993K921370MIC GASTRO-ENTEROSTOMY TUBE MODIFICATIONKNT1994-05-02
1200521463258766K904440LOCAL PLEXUS BLOCK ANESTHESIA CATHETER KITSCAZ1991-06-07
776141937089520K904440LOCAL PLEXUS BLOCK ANESTHESIA CATHETER KITSCAZ1991-06-07
3000751937089520K904440LOCAL PLEXUS BLOCK ANESTHESIA CATHETER KITSCAZ1991-06-07
346601816733505K896546HOMEPUMP (DISP. ELASTOMERIC INFUSION DEVICE)FRN1990-02-06
346611816733505K896546HOMEPUMP (DISP. ELASTOMERIC INFUSION DEVICE)FRN1990-02-06
48301535667724K884370CMS IV EXTENSION SETSFPK1988-11-07
48301164612875K882867CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBEKNT1988-09-21
776141164612875K882867CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBEKNT1988-09-21
3000751164612875K882867CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBEKNT1988-09-21
776141054832137K882199CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TESTLYR1988-10-06
3000751325893807K853253CORPAK FARRELL VALVE ENTERAL GASTRIC PRESSURE RELIKNT1985-11-05
48301891235015K853197MIC JEJUNAL FEEDING TUBEKNT1985-08-22
48301951937112K852707GASTRO-ENTEROSTOMY TUBEKNT1985-08-14
48302068908158K844745K-TUBEKNT1985-01-07
48301592010552K842115SPUNGARD & SURG. DRAPES-GOWNS & PACKSKKX1984-06-11
48301228551662K842076MIC GASTROSTOMY TUBEKNT1984-08-14
3000751015957460K840656ENTERNAL Y EXTENSION SET RECORDERKNT1984-04-04
48301496023656K831328NEONATAL NASOGASTRIC FEEDING TUBE-KNT1983-07-19
48301405459049K821906CORPAK ENTERIC FEEDING TUBE W/GUIDE TIPKNT1982-07-13
3503271023186011K260255AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)GEI2026-03-27
3296541619656872K250256Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))ETD2025-04-28
48301290593900K241185CORGRIP* SR NG/NI Tube Retention SystemKNT2024-10-25
48301377961161K240965CORTRAK* 2 Enteral Access System (20-0950)KNT2024-06-06
3296541948487392K232702Solo+ Tympanostomy Tube Device (TTD)ETD2024-05-20
48301788557953K220588Avanos* CORTRAK* 2 Enteral Access System (EAS)KNT2022-04-22
48301666950569K210983BD Epilor SyringeCAZ2022-05-19
3000751666950569K210983BD Epilor SyringeCAZ2022-05-19
3000752008389501K203066COOLIEF Cooled Radiofrequency Kit AdvancedGXI2020-12-22
3000751620091656K192491Coolief Radiofrequency Generator (CRG) SystemGXD2020-02-21
3000751916632868K192114Game Ready GRPro 2.1 SystemIRP2019-10-29
3000751240972443K181360ON-Q* Pump with BolusMEB2019-03-22
346601778171242K181360ON-Q* Pump with BolusMEB2019-03-22
346611778171242K181360ON-Q* Pump with BolusMEB2019-03-22
1200521778171242K181360ON-Q* Pump with BolusMEB2019-03-22
776141101759201K173955Mic-Key* SF Over-the-Wire Stoma Measuring DeviceKNT2018-01-26
3000751692667297K171685Med4 EliteIRP2017-09-29
48301235880095K162254Cedic Enteral ENFit Transition ConnectorsPIO2017-05-04
3000751891274771K162165ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent PumpMEA2017-08-29
346602071301763K162048EZstim*III Peripheral Nerve Stimulator/Nerve LocatorKOI2016-12-05
776141933753442K161232ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block KitBSO2016-09-30
3000751933753442K161232ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block KitBSO2016-09-30
3000751945764646K161039NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL)PNR2016-06-17
776141272354711K143164ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter SetBSO2014-12-02
3000751272354711K143164ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter SetBSO2014-12-02
346601583157480K143164ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter SetBSO2014-12-02
1200521583157480K143164ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter SetBSO2014-12-02
346601997144677K143095MiniStim MS-IVB Peripheral Nerve StimulatorBXN2015-03-24
3000752018867201K142012FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORSPIF2014-11-20
48301992069834K133599CORGRIPKNT2014-03-26
48301457107919K131532ELECTROMAGNETIC TRANSMITTING STYLETKNT2013-08-12
48301574205570K131254KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBEBTR2013-08-20
3000751541965933K131249ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIESMEB2014-02-03
346601709002281K131249ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIESMEB2014-02-03
346611709002281K131249ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIESMEB2014-02-03
1200521709002281K131249ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIESMEB2014-02-03
48301854821773K122653MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIESKNT2013-06-26
776141854821773K122653MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIESKNT2013-06-26
3000751111122538K122373NEOMED ORAL/ENTERAL SYRINGEFMF2012-09-20
48301573202026K120985KIMVENT MICROCUFF SUBGLOTTIC SUCTIONINGBTR2012-12-19
48301536009423K113351CORTRAK ENTERAL ACCESS DEVICEKNT2012-01-10
776141536009423K113351CORTRAK ENTERAL ACCESS DEVICEKNT2012-01-10
48301017281564K113333KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTSBTR2012-05-11
776141001434175K111355ECHOBRIGHTCAZ2011-09-16
3000751001434175K111355ECHOBRIGHTCAZ2011-09-16
346601520164872K111355ECHOBRIGHTCAZ2011-09-16
1200521520164872K111355ECHOBRIGHTCAZ2011-09-16
3000751823428285K102460AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATHBSO2011-01-13
346601512941914K102007PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC,CAZ2010-12-22
1200521512941914K102007PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC,CAZ2010-12-22
776141625404661K102007PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC,CAZ2010-12-22
3000751625404661K102007PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC,CAZ2010-12-22
48301508473689K100288NEOMED ENTERAL ONLY EXTENSION SETKNT2010-08-03
776141581315214K093662ECHOBRIGHTCAZ2010-06-24
3000751581315214K093662ECHOBRIGHTCAZ2010-06-24
48301371541921K093312KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEMKGC2009-12-08

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MEB372019-03-22
KNT362024-10-25
CAZ272022-05-19
BSO252016-09-30
BSP112009-02-09
FPA92007-05-24
FRN92005-12-08
BTR52013-08-20
FMF52012-09-20
GXI42020-12-22
LRO42003-03-31
KOI32016-12-05
ETD22025-04-28
IRP22019-10-29
MEA22017-08-29
KGC22009-12-08
CAC22008-10-24
GEI12026-03-27
GXD12020-02-21
PIO12017-05-04
PNR12016-06-17
BXN12015-03-24
PIF12014-11-20
FPD12008-12-29
NZP12006-09-29
KPE12000-06-09
OCZ11994-08-05
GCJ11994-04-29
GXZ11993-07-29
FPK11988-11-07
LYR11988-10-06
KKX11984-06-11

NDC#

PMN#

Applications#

GUDID#