Cetirizine Hydrochloride
Cetirizine Hydrochloride
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| AVENTIX MEDICAL INC | 5 | N | 2026-01-01 | 23282 Mill Creek Dr Ste 350 Laguna Hills CA US 92653 | ||
| 9611594 | 3002806436 | AVENT S. de R.L. de C.V. | 1 | N | 2026-01-01 | CIRCUITO INDUSTRIAL NO.40 COLONIA OBRERA NOGALES Sonora MX CP 84048 |
| 9680425 | 3007596547 | Avent S. de R.L. de C.V. | 1 | N | 2026-01-01 | Ave Noruega Edificio D-1B Fraccionamiento, Rubio TIJUANA Baja California MX 22116 |
| 3012112259 | 3012112259 | AVENTAMED DAC | 1 | N | 2026-01-01 | Rubicon Centre Rossa Avenue Bishopstown Cork IE T12Y275 |
| 3029300449 | 3029300449 | AVENTUSOFT | 1 | N | 2026-01-01 | 3651 FAU Blvd Suite 300 Boca Raton FL US 33431 |
| 2026095 | 2026095 | Avent Inc (aka Avanos Medical - Irvine) | 1 | N | 2020-04-25 | 43 Discovery Suite 100 Irvine CA US 92618 |
| 9680425 | 3007596547 | Avent S. de R.L. de C.V. | 1 | N | 2020-04-25 | Ave Noruega Edificio D-1B Fracc. Rubio TIJUANA Baja California MX 22116 |
| 3006646024 | 3006646024 | Avent, Inc. | 1 | N | 2020-04-25 | 6620 S. Memorial Place, Suite 100 Tucson AZ US 85756 |
| 3008520539 | 3008520539 | Avent S. de R.L. de C.V. | 1 | N | 2020-04-25 | Privada Baja California Edificio B-2 Fracc. Rubio Tijuana Baja California MX 22116 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 05391528890101 | Solo+ 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. | +353214928980 | john.vaughan@karlstorz.com |
| 05391528890156 | Solo+ 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. | +353214928980 | john.vaughan@karlstorz.com |
| 05391528890163 | Solo+ 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. | +353214928980 | john.vaughan@karlstorz.com |
| B596HT101Y2 | HemoTag - The HEMOTAG Device attaches to a patient's chest using standard electrodes, for 30 second, and picks up vibrational signals from the Heart. | 5612344040 | gary@aventusoft.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 34660 | 1915289421 | K994374 | SOAKER CATHETER | FRN | 2000-03-03 |
| 34661 | 1915289421 | K994374 | SOAKER CATHETER | FRN | 2000-03-03 |
| 4830 | 1515906826 | K993138 | BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT | KNT | 1999-10-20 |
| 34660 | 1436897700 | K992072 | BOLUS ACCESSORY SET | FPA | 1999-09-15 |
| 4830 | 1102927189 | K991879 | SPRING-WOUND EPIDURAL CATHETER | BSO | 1999-10-28 |
| 34660 | 1705130096 | K991513 | HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO | FPA | 1999-06-21 |
| 34661 | 1705130096 | K991513 | HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO | FPA | 1999-06-21 |
| 77614 | 1040505017 | K984502 | NERVE BLOCK INFUSION KIT | MEB | 1999-03-04 |
| 300075 | 1040505017 | K984502 | NERVE BLOCK INFUSION KIT | MEB | 1999-03-04 |
| 34660 | 1295690154 | K984502 | NERVE BLOCK INFUSION KIT | MEB | 1999-03-04 |
| 34661 | 1295690154 | K984502 | NERVE BLOCK INFUSION KIT | MEB | 1999-03-04 |
| 120052 | 1295690154 | K984502 | NERVE BLOCK INFUSION KIT | MEB | 1999-03-04 |
| 34660 | 1167044682 | K982946 | PAINBUSTER INFUSION KIT | MEB | 1998-11-18 |
| 34661 | 1167044682 | K982946 | PAINBUSTER INFUSION KIT | MEB | 1998-11-18 |
| 4830 | 1555596696 | K982894 | MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT | KNT | 1998-09-11 |
| 34661 | 1899270406 | K980987 | BECTON DICKINSON SYRINGE | FMF | 1998-06-11 |
| 34660 | 1775266362 | K980558 | PAINBUSTER INFUSION SYSTEM | MEB | 1998-05-28 |
| 34661 | 1775266362 | K980558 | PAINBUSTER INFUSION SYSTEM | MEB | 1998-05-28 |
| 300075 | 1374648461 | K972846 | BMC RF CANNULA | GXI | 1998-07-17 |
| 77614 | 1712118317 | K970178 | CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEM | KNT | 1997-07-21 |
| 300075 | 1712118317 | K970178 | CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEM | KNT | 1997-07-21 |
| 4830 | 1942442248 | K962042 | GLASS SYRINGE | FMF | 1996-10-08 |
| 4830 | 1491286503 | K961863 | PARACENTESIS TRAYS | LRO | 1996-05-28 |
| 77614 | 1046020786 | K954505 | EZ STIM | KOI | 1996-12-10 |
| 34660 | 1623490533 | K954505 | EZ STIM | KOI | 1996-12-10 |
| 34660 | 1260607088 | K944692 | C-SERIES HOMEPUMP | FPA | 1995-05-02 |
| 34661 | 1260607088 | K944692 | C-SERIES HOMEPUMP | FPA | 1995-05-02 |
| 300075 | 1144486026 | K942988 | FILTERED EXTENSION SETS | FPA | 1995-07-14 |
| 34661 | 1903252246 | K942988 | FILTERED EXTENSION SETS | FPA | 1995-07-14 |
| 4830 | 1991774932 | K941562 | 1ML LUER-LOK SYRINGE | FMF | 1994-05-26 |
| 4830 | 2041213426 | K941464 | BASICS ENDOSCOPY SYSTEM | OCZ | 1994-08-05 |
| 120052 | 1048818763 | K941153 | EPI-SPINAL ANESTHESIA TRAY | CAZ | 1995-05-30 |
| 4830 | 1721615606 | K941153 | EPI-SPINAL ANESTHESIA TRAY | CAZ | 1995-05-30 |
| 77614 | 1721615606 | K941153 | EPI-SPINAL ANESTHESIA TRAY | CAZ | 1995-05-30 |
| 300075 | 1721615606 | K941153 | EPI-SPINAL ANESTHESIA TRAY | CAZ | 1995-05-30 |
| 4830 | 1994272072 | K940431 | TECNADYNE 20/20 FOG INHIBITOR KIT | GCJ | 1994-04-29 |
| 4830 | 1131416427 | K926581 | MIC TRANSGASTRIC JEJUNAL TUBE | KNT | 1994-09-28 |
| 77614 | 1731930415 | K926349 | PROBLOC INSULATED NEEDLES | GXZ | 1993-07-29 |
| 4830 | 1424231615 | K924065 | MIC PEG TUBE | KNT | 1994-02-17 |
| 77614 | 1424231615 | K924065 | MIC PEG TUBE | KNT | 1994-02-17 |
| 300075 | 1424231615 | K924065 | MIC PEG TUBE | KNT | 1994-02-17 |
| 4830 | 1962462137 | K922667 | MIC LOW PROFILE GASTROSTOMY TUBE | KNT | 1993-12-01 |
| 300075 | 1962462137 | K922667 | MIC LOW PROFILE GASTROSTOMY TUBE | KNT | 1993-12-01 |
| 4830 | 1882648403 | K921652 | MIC TRANSGASTRIC JEJUNAL FEEDING TUBE KIT | KNT | 1994-05-02 |
| 4830 | 1545846993 | K921370 | MIC GASTRO-ENTEROSTOMY TUBE MODIFICATION | KNT | 1994-05-02 |
| 120052 | 1463258766 | K904440 | LOCAL PLEXUS BLOCK ANESTHESIA CATHETER KITS | CAZ | 1991-06-07 |
| 77614 | 1937089520 | K904440 | LOCAL PLEXUS BLOCK ANESTHESIA CATHETER KITS | CAZ | 1991-06-07 |
| 300075 | 1937089520 | K904440 | LOCAL PLEXUS BLOCK ANESTHESIA CATHETER KITS | CAZ | 1991-06-07 |
| 34660 | 1816733505 | K896546 | HOMEPUMP (DISP. ELASTOMERIC INFUSION DEVICE) | FRN | 1990-02-06 |
| 34661 | 1816733505 | K896546 | HOMEPUMP (DISP. ELASTOMERIC INFUSION DEVICE) | FRN | 1990-02-06 |
| 4830 | 1535667724 | K884370 | CMS IV EXTENSION SETS | FPK | 1988-11-07 |
| 4830 | 1164612875 | K882867 | CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE | KNT | 1988-09-21 |
| 77614 | 1164612875 | K882867 | CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE | KNT | 1988-09-21 |
| 300075 | 1164612875 | K882867 | CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE | KNT | 1988-09-21 |
| 77614 | 1054832137 | K882199 | CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TEST | LYR | 1988-10-06 |
| 300075 | 1325893807 | K853253 | CORPAK FARRELL VALVE ENTERAL GASTRIC PRESSURE RELI | KNT | 1985-11-05 |
| 4830 | 1891235015 | K853197 | MIC JEJUNAL FEEDING TUBE | KNT | 1985-08-22 |
| 4830 | 1951937112 | K852707 | GASTRO-ENTEROSTOMY TUBE | KNT | 1985-08-14 |
| 4830 | 2068908158 | K844745 | K-TUBE | KNT | 1985-01-07 |
| 4830 | 1592010552 | K842115 | SPUNGARD & SURG. DRAPES-GOWNS & PACKS | KKX | 1984-06-11 |
| 4830 | 1228551662 | K842076 | MIC GASTROSTOMY TUBE | KNT | 1984-08-14 |
| 300075 | 1015957460 | K840656 | ENTERNAL Y EXTENSION SET RECORDER | KNT | 1984-04-04 |
| 4830 | 1496023656 | K831328 | NEONATAL NASOGASTRIC FEEDING TUBE- | KNT | 1983-07-19 |
| 4830 | 1405459049 | K821906 | CORPAK ENTERIC FEEDING TUBE W/GUIDE TIP | KNT | 1982-07-13 |
| 350327 | 1023186011 | K260255 | AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) | GEI | 2026-03-27 |
| 329654 | 1619656872 | K250256 | Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000)) | ETD | 2025-04-28 |
| 4830 | 1290593900 | K241185 | CORGRIP* SR NG/NI Tube Retention System | KNT | 2024-10-25 |
| 4830 | 1377961161 | K240965 | CORTRAK* 2 Enteral Access System (20-0950) | KNT | 2024-06-06 |
| 329654 | 1948487392 | K232702 | Solo+ Tympanostomy Tube Device (TTD) | ETD | 2024-05-20 |
| 4830 | 1788557953 | K220588 | Avanos* CORTRAK* 2 Enteral Access System (EAS) | KNT | 2022-04-22 |
| 4830 | 1666950569 | K210983 | BD Epilor Syringe | CAZ | 2022-05-19 |
| 300075 | 1666950569 | K210983 | BD Epilor Syringe | CAZ | 2022-05-19 |
| 300075 | 2008389501 | K203066 | COOLIEF Cooled Radiofrequency Kit Advanced | GXI | 2020-12-22 |
| 300075 | 1620091656 | K192491 | Coolief Radiofrequency Generator (CRG) System | GXD | 2020-02-21 |
| 300075 | 1916632868 | K192114 | Game Ready GRPro 2.1 System | IRP | 2019-10-29 |
| 300075 | 1240972443 | K181360 | ON-Q* Pump with Bolus | MEB | 2019-03-22 |
| 34660 | 1778171242 | K181360 | ON-Q* Pump with Bolus | MEB | 2019-03-22 |
| 34661 | 1778171242 | K181360 | ON-Q* Pump with Bolus | MEB | 2019-03-22 |
| 120052 | 1778171242 | K181360 | ON-Q* Pump with Bolus | MEB | 2019-03-22 |
| 77614 | 1101759201 | K173955 | Mic-Key* SF Over-the-Wire Stoma Measuring Device | KNT | 2018-01-26 |
| 300075 | 1692667297 | K171685 | Med4 Elite | IRP | 2017-09-29 |
| 4830 | 1235880095 | K162254 | Cedic Enteral ENFit Transition Connectors | PIO | 2017-05-04 |
| 300075 | 1891274771 | K162165 | ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump | MEA | 2017-08-29 |
| 34660 | 2071301763 | K162048 | EZstim*III Peripheral Nerve Stimulator/Nerve Locator | KOI | 2016-12-05 |
| 77614 | 1933753442 | K161232 | ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit | BSO | 2016-09-30 |
| 300075 | 1933753442 | K161232 | ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit | BSO | 2016-09-30 |
| 300075 | 1945764646 | K161039 | NeoConnect 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) | PNR | 2016-06-17 |
| 77614 | 1272354711 | K143164 | ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set | BSO | 2014-12-02 |
| 300075 | 1272354711 | K143164 | ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set | BSO | 2014-12-02 |
| 34660 | 1583157480 | K143164 | ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set | BSO | 2014-12-02 |
| 120052 | 1583157480 | K143164 | ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set | BSO | 2014-12-02 |
| 34660 | 1997144677 | K143095 | MiniStim MS-IVB Peripheral Nerve Stimulator | BXN | 2015-03-24 |
| 300075 | 2018867201 | K142012 | FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS | PIF | 2014-11-20 |
| 4830 | 1992069834 | K133599 | CORGRIP | KNT | 2014-03-26 |
| 4830 | 1457107919 | K131532 | ELECTROMAGNETIC TRANSMITTING STYLET | KNT | 2013-08-12 |
| 4830 | 1574205570 | K131254 | KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE | BTR | 2013-08-20 |
| 300075 | 1541965933 | K131249 | ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES | MEB | 2014-02-03 |
| 34660 | 1709002281 | K131249 | ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES | MEB | 2014-02-03 |
| 34661 | 1709002281 | K131249 | ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES | MEB | 2014-02-03 |
| 120052 | 1709002281 | K131249 | ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES | MEB | 2014-02-03 |
| 4830 | 1854821773 | K122653 | MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES | KNT | 2013-06-26 |
| 77614 | 1854821773 | K122653 | MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES | KNT | 2013-06-26 |
| 300075 | 1111122538 | K122373 | NEOMED ORAL/ENTERAL SYRINGE | FMF | 2012-09-20 |
| 4830 | 1573202026 | K120985 | KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING | BTR | 2012-12-19 |
| 4830 | 1536009423 | K113351 | CORTRAK ENTERAL ACCESS DEVICE | KNT | 2012-01-10 |
| 77614 | 1536009423 | K113351 | CORTRAK ENTERAL ACCESS DEVICE | KNT | 2012-01-10 |
| 4830 | 1017281564 | K113333 | KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS | BTR | 2012-05-11 |
| 77614 | 1001434175 | K111355 | ECHOBRIGHT | CAZ | 2011-09-16 |
| 300075 | 1001434175 | K111355 | ECHOBRIGHT | CAZ | 2011-09-16 |
| 34660 | 1520164872 | K111355 | ECHOBRIGHT | CAZ | 2011-09-16 |
| 120052 | 1520164872 | K111355 | ECHOBRIGHT | CAZ | 2011-09-16 |
| 300075 | 1823428285 | K102460 | AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH | BSO | 2011-01-13 |
| 34660 | 1512941914 | K102007 | PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC, | CAZ | 2010-12-22 |
| 120052 | 1512941914 | K102007 | PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC, | CAZ | 2010-12-22 |
| 77614 | 1625404661 | K102007 | PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC, | CAZ | 2010-12-22 |
| 300075 | 1625404661 | K102007 | PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC, | CAZ | 2010-12-22 |
| 4830 | 1508473689 | K100288 | NEOMED ENTERAL ONLY EXTENSION SET | KNT | 2010-08-03 |
| 77614 | 1581315214 | K093662 | ECHOBRIGHT | CAZ | 2010-06-24 |
| 300075 | 1581315214 | K093662 | ECHOBRIGHT | CAZ | 2010-06-24 |
| 4830 | 1371541921 | K093312 | KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEM | KGC | 2009-12-08 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| MEB | 37 | 2019-03-22 |
| KNT | 36 | 2024-10-25 |
| CAZ | 27 | 2022-05-19 |
| BSO | 25 | 2016-09-30 |
| BSP | 11 | 2009-02-09 |
| FPA | 9 | 2007-05-24 |
| FRN | 9 | 2005-12-08 |
| BTR | 5 | 2013-08-20 |
| FMF | 5 | 2012-09-20 |
| GXI | 4 | 2020-12-22 |
| LRO | 4 | 2003-03-31 |
| KOI | 3 | 2016-12-05 |
| ETD | 2 | 2025-04-28 |
| IRP | 2 | 2019-10-29 |
| MEA | 2 | 2017-08-29 |
| KGC | 2 | 2009-12-08 |
| CAC | 2 | 2008-10-24 |
| GEI | 1 | 2026-03-27 |
| GXD | 1 | 2020-02-21 |
| PIO | 1 | 2017-05-04 |
| PNR | 1 | 2016-06-17 |
| BXN | 1 | 2015-03-24 |
| PIF | 1 | 2014-11-20 |
| FPD | 1 | 2008-12-29 |
| NZP | 1 | 2006-09-29 |
| KPE | 1 | 2000-06-09 |
| OCZ | 1 | 1994-08-05 |
| GCJ | 1 | 1994-04-29 |
| GXZ | 1 | 1993-07-29 |
| FPK | 1 | 1988-11-07 |
| LYR | 1 | 1988-10-06 |
| KKX | 1 | 1984-06-11 |
Cetirizine Hydrochloride
Aventamed Dac
Avent America, Inc.
AVENT AMERICA, INC.
AVENT AMERICA, INC.
AVENT AMERICA, INC.
2024-07-19
2024-07-19
2024-07-19
2024-01-29