FDA.reportPublic FDA data

AVANTOR PERFORMANCE MATERIALS, LLC

Matched from indexed company URL: AVA, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10451251045125AVANTOR PERFORMANCE MATERIALS, LLC1N2026-01-017001 MARTIN LUTHER KING JR BLVD Paris KY US 40361
15271051000069183AVALIGN INTEGRATED MEDICAL SOLUTIONS, INC1N2026-01-017124 Industrial Park Blvd Mentor OH US 44060
18354443000717687Avalign Delivery Systems Division1N2026-01-012121 SOUTHTECH DRIVE SUITE 600 Greenwood IN US 46143
30039516293003951629AVALON EYEWEAR, INC.1Y2026-01-01170 LEGRAND AVE Northvale NJ US 07647
30047373143004737314AVALON DENTAL CERAMICS INC.1Y2026-01-01168 SAN LAZARO AVENUE Sunnyvale CA US 94086
30048394043004839404AVAZZIA, INC.1N2026-01-0113140 Coit Rd Ste 515 DALLAS TX US 75240
30065525613006552561Avani Patel1N2026-01-01541 Church At North Hills St Raleigh NC US 27609
30088646033008864603AVALIGN TECHNOLOGIES, Inc.1N2026-01-018727 Clinton Park Dr Fort Wayne IN US 46825
30096689373009668937AVACEN, INC.1N2026-01-016451 El Camino Real Ste C Carlsbad CA US 92009
30101622433010162243AVANT WELLNESS SYSTEMS INC1N2026-01-012706 Conejo Center Dr Thousand Oaks CA US 91320
30106024893010602489Avani Patel1N2026-01-01541 Church At North Hills St Raleigh NC US 27609
30112701813011270181Avanos Medical, Inc.1Y2026-01-015405 Windward Parkway Alpharetta GA US 30004
30126897383012689738AVACORE TECHNOLOGIES, INC.1N2026-01-01600 S Wagner Rd Ann Arbor MI US 48103
30134133933013413393Avalign Additive / Slice Manufacturing Studios1Y2026-01-011810 Triplett Blvd Akron OH US 44306
30135464373013546437Avani Patel1N2026-01-01541 Church At North Hills St Raleigh NC US 27609
30144323113014432311AVANTSONIC TECHNOLOGY CO., LTD.1N2026-01-012F, Building 4A, No. 21, Changkang Road, Yuzui Town, Liangjiang Chongqing CN 401133
30153350343015335034Avani Patel1N2026-01-01541 Church At North Hills St Raleigh NC US 27609
30159834163015983416AVAVA, INC.1N2026-01-01318 Bear Hill Rd Ste 1 Waltham MA US 02451
30162478523016247852AVANTI ORTHOPAEDICS LLC1N2026-01-011245 Hollow Road Penn Valley PA US 19072
30172317403017231740Avaline Medical Limited Liability Company1N2026-01-011965 Swarthmore Ave Suite 8 Lakewood NJ US 08701
30275789623027578962AVATION MEDICAL1N2026-01-011375 Perry St Suite 13-150 Columbus OH US 43201
30276457313027645731AVATAR MEDICAL1N2026-01-0111 Rue de lourmel paris Ile-de-France FR 75015
30300888453030088845AVATAR MEDICAL USA Inc1Y2026-01-011049 El Monte Ave, Suite C #152 Mountain View CA US 94040
30353670393035367039AVAILS MEDICAL, INC.1N2026-01-011080 OBrien Drive, Suite A Menlo Park CA US 94025
30419134763041913476AVANT-GARDE MEDICAL INNOVATION1N2026-01-01124 Montura Dr Ponte Vedra Beach FL US 32082

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1750921622906617P160057TRIVISCMOZ2017-11-13
1750921770903472P140005GENVISC 850MOZ2015-09-02
1750921515906826K993138BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KITKNT1999-10-20
233651247394974K992679SURGEON POWDER-FREE GLOVES, LATEX, STERILEKGO1999-10-21
1678991247394974K992679SURGEON POWDER-FREE GLOVES, LATEX, STERILEKGO1999-10-21
233651259699070K992678PATIENT NITRILE EXAMINATION GLOVES POWDER FREE CHLORINATEDLZA1999-11-17
233651490238048K992676PATIENT LATEX EXAMINATION POWDER-FREE POLYMER COATED GLOVESLYY1999-12-16
1750921102927189K991879SPRING-WOUND EPIDURAL CATHETERBSO1999-10-28
1750921040505017K984502NERVE BLOCK INFUSION KITMEB1999-03-04
1750921555596696K982894MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KITKNT1998-09-11
233651840286507K973020PATIENT EXAMINATION POWDER-FREE GLOVESLYY1998-01-06
1750921374648461K972846BMC RF CANNULAGXI1998-07-17
1750921712118317K970178CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEMKNT1997-07-21
1943301905673836K962545DENTAL, MEDICAL INSTRUMENT CASES & CASSETTEKCT1997-03-07
1750921491286503K961863PARACENTESIS TRAYSLRO1996-05-28
1750921284041895K955031MAXISTIMKOI1996-12-10
1750921786782537K954633CONMED ELECTROSURGICAL GROUNDING PADGEI1995-10-23
1750921046020786K954505EZ STIMKOI1996-12-10
1750921210611779K951533EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KITKDH1995-07-05
1750921241582091K945715MONOJECT(R) PISTON SYRINGES; 3,6,12,20,35 AND 60CC SIZESFMF1995-03-01
1750921991774932K9415621ML LUER-LOK SYRINGEFMF1994-05-26
1750922041213426K941464BASICS ENDOSCOPY SYSTEMOCZ1994-08-05
1750921721615606K941153EPI-SPINAL ANESTHESIA TRAYCAZ1995-05-30
1750921994272072K940431TECNADYNE 20/20 FOG INHIBITOR KITGCJ1994-04-29
1750921885653350K932790THERMAL OPTIONKGE1994-01-28
1750921131416427K926581MIC TRANSGASTRIC JEJUNAL TUBEKNT1994-09-28
1750921731930415K926349PROBLOC INSULATED NEEDLESGXZ1993-07-29
1750921424231615K924065MIC PEG TUBEKNT1994-02-17
1750921166038213K923672COX DISPOSABLE ENDOSCOPE CLEANING BRUSHFEB1992-09-23
1750921078097858K923671COX DISPOSABLE POLYPECTOMY SNARESFDI1992-10-13
1750921776077421K923487BAL CATHKTR1993-07-30
1750921962462137K922667MIC LOW PROFILE GASTROSTOMY TUBEKNT1993-12-01
1750921882648403K921652MIC TRANSGASTRIC JEJUNAL FEEDING TUBE KITKNT1994-05-02
1750921545846993K921370MIC GASTRO-ENTEROSTOMY TUBE MODIFICATIONKNT1994-05-02
1750921731801615K913184MS-III MINISTIMBXN1991-10-07
1750921937089520K904440LOCAL PLEXUS BLOCK ANESTHESIA CATHETER KITSCAZ1991-06-07
1750921469399115K894868WILTEK VARICES INJECTION NEEDLEFBK1989-12-21
1750921470192069K892218ENDO-SPONGEMNL1989-05-31
1750921535667724K884370CMS IV EXTENSION SETSFPK1988-11-07
1750921164612875K882867CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBEKNT1988-09-21
1750921054832137K882199CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TESTLYR1988-10-06
1750921624955769K881842TRACERBXN1988-08-31
1750921828512288K874004ALLIGATOR JAW GRASPING FORCEP (MODEL 23/125)OCZ1987-12-29
1750922026330101K873732TRACH CARE START KITBSY1987-10-13
1750921470537157K870662MODEL SKCK STERILE KNOB COVER KITBXM1987-10-28
1750921387438991K870338MODEL MS-II MINISTIMBXN1987-03-11
1750921618839626K864830TEFLON-COATED HYPODERMIC NEEDLES/REGIONAL BLOCKBXN1987-01-12
1750921287370914K864829MODEL NS-3CC NEURO-STIM PERIPHERAL NERVE STIMULATBXN1987-01-12
1750922035879881K860510NEONATE PERCUSSORBYI1986-02-20
1750921325893807K853253CORPAK FARRELL VALVE ENTERAL GASTRIC PRESSURE RELIKNT1985-11-05
1750921891235015K853197MIC JEJUNAL FEEDING TUBEKNT1985-08-22
1750921951937112K852707GASTRO-ENTEROSTOMY TUBEKNT1985-08-14
1750922068908158K844745K-TUBEKNT1985-01-07
1750921228551662K842076MIC GASTROSTOMY TUBEKNT1984-08-14
1750921848689298K841258FOREIGN BODY PROTECTORFED1984-07-09
1750921623169931K840800POLYP-SAVER SLEVEOCZ1984-03-23
1750921496023656K831328NEONATAL NASOGASTRIC FEEDING TUBE-KNT1983-07-19
1750921405459049K821906CORPAK ENTERIC FEEDING TUBE W/GUIDE TIPKNT1982-07-13
1750921161226265K800934R2 ESU CABLE-ADAPTER MODELS 160,161IKD1980-05-20
3192101072583134K253950Avatar Medical VisionLLZ2026-03-30
3192101533910388K252665brAIn™ Shoulder PositioningQIH2025-10-20
1943301135149702K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemOVD2025-07-10
1750921123451774K242057COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)GXD2024-08-14
1750921290593900K241185CORGRIP* SR NG/NI Tube Retention SystemKNT2024-10-25
1750921377961161K240965CORTRAK* 2 Enteral Access System (20-0950)KNT2024-06-06
3355621024130419K231536eQUANT SystemQZX2024-02-08
2204421689631744K230986Bladder ScannerIYO2023-12-29
2373421489232083K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated ScrewsHWC2022-11-23
3192101679444742K222035Avatar Medical Software V1LLZ2023-05-24
3158611885850076K221268SR-1 Skin Treatment SystemONG2022-11-21
1750921788557953K220588Avanos* CORTRAK* 2 Enteral Access System (EAS)KNT2022-04-22
3180791849294212K220454Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile ApplicationNAM2023-04-03
2373421486842479K211592Avanti Orthopaedics Ulnar Shortening SystemHRS2021-07-16
1750922008389501K203066COOLIEF Cooled Radiofrequency Kit AdvancedGXI2020-12-22
1943301112063166K193066Steripack cases and Tray SystemsKCT2020-08-06
1750921620091656K192491Coolief Radiofrequency Generator (CRG) SystemGXD2020-02-21
1750921916632868K192114Game Ready GRPro 2.1 SystemIRP2019-10-29
642631752358396K191951Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ DeviceNFO2021-04-27
1750921667400519K191340CORTRAK* 2 Equilateral Enteral Access SystemKNT2019-06-04
2373421612200176K191118Avanti Distal Radius and Forearm SystemHRS2019-12-13
1750922043658935K183540Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL)PNR2019-04-30
1750921240972443K181360ON-Q* Pump with BolusMEB2019-03-22
1750921101759201K173955Mic-Key* SF Over-the-Wire Stoma Measuring DeviceKNT2018-01-26
1678991619729541K172420Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling ClaimKGO2017-09-29
1750921692667297K171685Med4 EliteIRP2017-09-29
2204421179962970K171528Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5)IYO2018-01-24
1750921971882455K163461Coolief* Cooled RF ProbeGXI2017-04-13
1750921846286155K163236COOLIEF Cooled Radiofrequency KitGXI2016-12-16
642631974052423K162392AvazziaNUH2017-05-12
1750921891274771K162165ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent PumpMEA2017-08-29
1750921019622059K162110CORGRIP NG/NI Tube Retention SystemKNT2016-09-15
1750921436044105K162048EZstim*III Peripheral Nerve Stimulator/Nerve LocatorKOI2016-12-05
1750921626200448K161979ENFit enteral syringePNR2017-03-22
1750921933753442K161232ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block KitBSO2016-09-30
1750921945764646K161039NeoConnect 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
1750921216076892K152857NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip CapsPNR2015-12-17
2075691404296386K151750Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-SterileLZA2016-08-03
1750921272354711K143164ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter SetBSO2014-12-02
1750921547755995K143095MiniStim MS-IVB Peripheral Nerve StimulatorBXN2015-03-24
1750922018867201K142012FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORSPIF2014-11-20
1750921535042922K140658THERMOGARD DISPERSIVE ELECTRODES, THERMOGARD PLUS ABC DISPERSIVE ELECTRODESGEI2014-07-10
1423741068138980K133981AVACEN 100IRT2014-08-15
1750921992069834K133599CORGRIPKNT2014-03-26
1750921457107919K131532ELECTROMAGNETIC TRANSMITTING STYLETKNT2013-08-12
1750921574205570K131254KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBEBTR2013-08-20
1750921541965933K131249ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIESMEB2014-02-03
1802951315195335K123474AVANT LASERILY2013-12-03
642631227124718K123099Best-AV2 Pro-Sport(tm)GZJ2014-05-23
1750921854821773K122653MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIESKNT2013-06-26
1750921111122538K122373NEOMED ORAL/ENTERAL SYRINGEFMF2012-09-20
1750921573202026K120985KIMVENT MICROCUFF SUBGLOTTIC SUCTIONINGBTR2012-12-19
1750921090079818K120182NEOMED GASTROINTESTINAL TUBE AND ACCESSORIESKNT2012-04-19
1750921536009423K113351CORTRAK ENTERAL ACCESS DEVICEKNT2012-01-10
1750921017281564K113333KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTSBTR2012-05-11
1750921779613303K112562BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETEROYI2011-12-15
1750921001434175K111355ECHOBRIGHTCAZ2011-09-16
2075692048507018K103337MULTIPLE NAMELZA2011-02-25
2273762048507018K103337MULTIPLE NAMELZA2011-02-25

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KNT302024-10-25
GXI92020-12-22
CAZ92011-09-16
BSO82016-09-30
LYY72010-09-03
LZA62016-08-03
BXN62015-03-24
GEI62014-07-10
MEB52019-03-22
KGO52017-09-29
BTR52013-08-20
BSP52009-02-09
PNR42019-04-30
FMF42012-09-20
FPD42010-04-22
GXD32024-08-14
KOI32016-12-05
FRN32005-12-08
OCZ31994-08-05
LLZ22026-03-30
IYO22023-12-29
HRS22021-07-16
KCT22020-08-06
IRP22019-10-29
MOZ22017-11-13
MEA22017-08-29
IRT22014-08-15
GZJ22014-05-23
GXY22009-12-18
KGC22009-12-08
DWJ22004-06-22
LRO22003-03-31
QIH12025-10-20
OVD12025-07-10
QZX12024-02-08
NAM12023-04-03
HWC12022-11-23
ONG12022-11-21
NFO12021-04-27
NUH12017-05-12

NDC#

Lumryz

Avadel CNS Pharmaceuticals, LLC

sodium oxybate

Lumryz

Avadel CNS Pharmaceuticals, LLC

sodium oxybate

Lumryz

Avadel CNS Pharmaceuticals, LLC

sodium oxybate

Lumryz

Avadel CNS Pharmaceuticals, LLC

sodium oxybate

Lumryz

Avadel CNS Pharmaceuticals, LLC

sodium oxybate

PHUEL

AVADIM HOLDINGS, INC.

MAGNESIUM SULFATE HEPTAHYDRATE

PHUEL

AVADIM HOLDINGS, INC.

MAGNESIUM SULFATE HEPTAHYDRATE

51 records. Showing 1-40. Next

PMN#

84 records. Showing 1-40. Next

Applications#