FDA.reportPublic FDA data

NA

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10295361029536NASHVILLE DENTAL, INC.1Y2026-01-011229 Northgate Business Pkwy Madison TN US 37115
10622021000511279NATIONAL VISION, INC.1Y2026-01-01296 Grayson Hwy LAWRENCEVILLE GA US 30046
10626683001639746NASHVILLE SURGICAL INSTRUMENTS1N2026-01-012005 KUMAR LANE Springfield TN US 37172
11228231000123441NAI ACQUISITION, LLC1N2026-01-01217 Cember Way Ste D Summerville SC US 29483
13143441000087290Nalge Nunc International Corporation1Y2026-01-0175 Panorama Creek Dr Rochester NY US 14625
13193901319390NASIFF ASSOC., INC.1N2026-01-01841-1 COUNTY ROUTE 37 CENTRAL SQUARE NY US 13036
17208391000065475Navajo Manufacturing Company Inc.1Y2026-01-015330 FOX ST. Denver CO US 80216
17226181000160330NATRACARE, LLC.1Y2026-01-013620 W. 10th Street Unit B, #406 Greeley CO US 80634
20239882023988Natus Medical Incorporated1N2026-01-016225 Nancy Ridge Dr SAN DIEGO CA US 92121
20270632027063NATIONAL MEDICAL PRODUCTS, INC.1N2026-01-0157 PARKER ST. Irvine CA US 92618
20280461000125536NATIONAL HOSPITAL PACKAGING1N2026-01-01710 S. STIMSON AVE. City of Industry CA US 91745
20859473000204191NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.1N2026-01-0122134 SHERMAN WAY CANOGA PARK CA US 91303
22497493003093199NATIONWIDE IMAGING SERVICE, INC.1Y2026-01-012301 Atlantic Avenue Manasquan NJ US 08736
24355321000119785Nationwide Dentures1Y2026-01-011066 Broadway Ground Floor Woodmere NY US 11598
24385953000287679NARISHIGE INTERNATIONAL USA, INC.1Y2026-01-01415 Bayview Ave Amityville NY US 11701
25294891000121431NASORCAP MEDICAL, INC.1N2026-01-01105 Harvest Circle Venetia PA US 15367
80210227163NANNINI ITALIAN QUALITY SRL1N2026-01-01VIA J.F.KENNEDY, 10 REGGIO EMILIA Reggio Emilia IT 42124
80221681000213912Nadia Prather1N2026-01-016280 Center Hill Ave CINCINNATI OH US 45224
80302943003672538NAKANISHI OPTICAL PRODUCTS CORP.1N2026-01-01NO. 1 OSAKA EKIMAE BLDG., 3-1-200 UMEDA, 1-CHOME, KITA-KU OSAKA ?saka JP 5300001
80438893003206796Nagase Diagnostics Co., Ltd, Ohito Diagnostics Plant1N2026-01-01632-1 Mifuku Izunokuni-shi Shizuoka JP 410-2321
96121973002807554Natus Medical Denmark ApS1N2026-01-01Hoerskaetten 9 TAASTRUP Hovedstaden DK DK-2630
96150373003261083Nathan Hardesty1N2026-01-01595 Anglum Rd Bldg 1, 2nd Flr. Hazelwood MO US 63042
96150633003821398Naphtali Deutsch1N2026-01-019559 Collins Ave Apt 1007 Surfside FL US 33154
96157543008237827Nathan Hardesty1N2026-01-01595 Anglum Rd Bldg. 1, 2nd Flr. Hazelwood MO US 63042
96157553007808629Nathan Hardesty1N2026-01-01595 Anglum Rd Bldg 1, 2nd Floor Hazelwood MO US 63042

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
381281843075132K993881GENX CULTURE DISHMQK2000-02-14
526281373025996K993689AED CYSTOSCOPEFAJ1999-12-15
526281926335817K993688AED LAPAROSCOPEGCJ1999-12-06
430691074194855K993616CARDIO-CARD INTERPRETATION SYSTEM ILOS2000-04-10
97621047790559K992993ETEST FOR QUINUPRISTIN/DALFOPRISTINLTX1999-11-16
526281774773226K991656AED ARTHROSCOPEHRX1999-12-02
97621991472259K990722ETEST FOR CEFUROXIMEJWY1999-04-22
97621709348519K990297ETEST MINOCYCLINEJWY1999-03-22
97621769142822K983027TRIMETHOPRIM/SULPHAMETHOXAZOLEJWY1998-10-02
97621151636697K982868ETEST RIFAMPICIN WITH INDICATIONS FOR S. PNEUMONIAEJWY1998-09-30
97621145803955K981139ETEST CEFTRIAXONEJWY1998-06-01
97621814732467K981138ETEST CIPROFLOXACINJWY1998-06-05
97621739616353K981137ETEST CEFOTAXIMEJWY1998-06-09
97621427392458K981136ETEST FOSFOMYCINJWY1998-06-09
97621905593043K981135ETEST BENZYLPENICILLINJWY1998-06-09
97621920499570K981134ETEST TETRACYCLINEJWY1998-05-28
97622020091081K980348ETEST VANCOMYCINJWY1998-05-29
97621780085862K980345ETEST CEFTRIAXONEJWY1998-05-27
97621264994980K980342ETEST CHLORAMPHENICALJWY1998-05-29
97621453900822K980338ETEST OFLOXACINJWY1998-05-28
812411407419350K980082J-TIP NEEDLESS INJECTORKZE1998-03-04
771891768956678K973621PRE-VIEW CHOLANGIOGRAPHY CLAMPGBZ1997-12-17
812411220877092K973254J-TIP INJECTORKZE1997-11-24
430691062624025K972795CARDIO-CARD MANAGEMENT SYSTEM IIDXN1998-02-20
2122401611264281K971799PRECISION FLOW OSV IIJXG1998-02-06
97621978991899K971697ETEST FOR LEVOFLOXACINJWY1997-07-14
97621695768081K971694ETEST FOR CEFTAZIDIMEJWY1997-06-30
97621102171800K970473ETEST SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAEJWY1997-05-01
97621615278985K970210AMIKACINJWY1997-05-01
2122401857378106K964923CODMAN LUMBAR DRAINAGE CATHETER KITJXG1997-06-25
97622040602910K964203PIPERACILLIN/TAZOBACTAM 4JWY1996-12-18
97621693424160K963107ETEST FOR CEFEPIMEJWY1996-10-24
2122401770324098K962928COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/)GWM1996-12-20
97621439008952K962794ETEST FOR AZTREONAMJWY1996-08-30
97621340543445K961519ETEST SUBMISSION FOR AZITHROMYCINJWY1996-07-05
97621439548773K961517ETEST SUBMISSION FOR CEFOTETANJWY1996-07-05
97621484640792K960991ETEST SUBMISSION FOR AMOXICILLINJWY1996-10-08
97621945427109K960989ETEST SUBMISSION FOR IMIPENEMJWY1996-05-20
430691347955126K960544CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEMDRT1996-08-07
2122401016658295K960159CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS)JXG1996-10-25
97621888053662K955920THE E TEST CEFTIZOXIMEJWY1996-02-22
2122401837910908K955832CORDIS VENTRICULAR ANTECHAMBER (VA)JXG1996-03-25
2122401274145477K954021EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II)JXG1995-10-24
97621334815790K953223PIPERACILIN TAZOBACTAM 4 UGJWY1995-08-15
97621636371585K951879TICARCILLIN/CLAVULANIC ACID 2JWY1995-07-07
97621003271432K950328AMOXICILLIN/CLAVULANIC ACID 2/1JWY1995-04-14
2122401229967970K950315CORDIS CSF RESERVOIRLKG1995-05-09
97621866906169K946364E TEST FOR OFLOXACINJWY1995-05-02
97621963799493K945433ETEST/CEFTRIAXONE/HAEMOPHILUS/PNEUMOCOCCUSJWY1995-03-17
2122401096860316K944595CORDIS HORIZONTAL-VERICAL VALVE SYSTEMJXG1995-10-19
97622024019817K935519ETEST FOR AMPICILLIN/SULBACTAM 2/1JWY1994-11-04
2122401190308639K932273CORDIS TUNNELERGYK1993-08-23
2122402026442823K925810CORDIS POLYPROPYLENE BURR HOLE RESERVOIRJXG1994-03-02
97601808495193K923579MINIVIDAS INSTRUMENTJJE1993-02-12
97621808495193K923579MINIVIDAS INSTRUMENTJJE1993-02-12
2122401616666668K921936CORDIS POLYPROPYLENE STRAIGHT, T & Y CONNECTORJXG1992-10-30
430691565086338K920020CARDIO-CARD ECG MANAGEMENT SYSTEMDPS1992-07-09
2122401310138223K914735VENTRICULAR PRESSURE MONITORING KIT, MODEL 110-4HMGWM1992-01-17
97621382785368K913459THE E TEST, MODIFICATIONJWY1991-09-25
441771616808796K911970NASAL/ORAL 02 DELIVERY AND GAS SAMPLING DEVICECCK1992-08-14
2122401299447256K911433RIGHT-ANGLE CATHETER FOR VENTRICULAR DRAINAGEJXG1991-09-16
2122401029984437K910938CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II)JXG1991-08-16
97622035124959K910304RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIALQL1991-07-26
2122401039652435K895868HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSEGYK1989-10-31
97601689820147K891385VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS)DEW1989-04-18
97621689820147K891385VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS)DEW1989-04-18
812411240097068K884293J-TIP INJECTOR SYSTEMKZE1989-01-09
2122401754520275K861377STANDARD/PEDIATRIC CORDIS HYDROCEPHALUS VALVESJXG1986-06-19
2122401413948315K811288SPETZLER LUMBAR-PERITONEAL SYSTEMJXG1981-06-26
2122401601327080K802586AMERICAN HEYER-SCHULTE LOW PROFILE VALVEJXG1980-12-18
2122401937071511K771529PERITONEAL INTRODUCER & SHEATHGYK1977-08-16
97621060592356K260447ETEST Gepotidacin (GEP) (0.016-256 µg/mL)JWY2026-04-21
97621844204550K250856ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)JWY2025-06-12
97621355881271K250274ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)JWY2025-04-30
3390081750919494K242198ICS Dizcovery (1091)GWN2025-02-14
3390081059094408K233649ALGO Pro Newborn Hearing Screener (ALGO Pro)GWJ2024-03-08
766201908238062K232864EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream IILCX2024-01-26
97621404246335K232395ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUDJWY2023-10-05
766201902513409K221798Finger Pulse Oximeter, Model: X1906PDQA2023-05-04
97621955519805K212461VITEK MS PRIMEQBN2022-03-15
97621375712980K210757ETEST Fosfomycin (FO) (0.032-512 µg/mL)JWY2021-11-12
3390081509260693K203500RetCam EnvisionHKI2021-04-13
97621663424570K200512ETEST Plazomicin (PLZ) (0.016-256 µg/mL)JWY2020-05-07
97621192737158K192738ETEST Delafloxacin (DFX) (0.002-32 µg/mL)JWY2019-11-26
97621709209715K192050ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)JWY2019-09-27
97621339031084K191953ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)JWY2019-08-22
97621578543520K190154ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)JWY2019-05-01
97621683691697K183031ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)JWY2019-01-11
3390081708243813K182178neoBLUE blanket LED Phototherapy SystemLBI2018-12-13
97621021809147K181412VITEK MSQBN2018-12-21
97611317963395K181092CHROMID CARBA agar (CARB)JSO2018-07-06
97621539421213K180936ETEST Telavancin (TLA) (0.002-32 ug/mL)JWY2018-07-03
97621452655697K172150Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL)JWY2017-09-15
97621999161146K170670Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)JWY2017-05-31
526281762863451K170285AED SinuscopeEOB2017-08-01
2258981516592217K170147Lucica Glycated Albumin-LLCP2017-10-12
97611072208669K163042chromID Strepto B agarPQZ2017-01-27
97621076966828K162950VITEK MSPEX2017-07-22
2122401809559173K162437Codman EDS3 CSF External Drainage SystemJXG2016-10-28
97621004075417K162385RAPIDEC CARBA NPPTJ2017-04-27
2122401447822492K161992Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt SystemsJXG2016-09-22
3390081487501581K161707Madsen ZodiacETY2016-09-01
3390081921649998K160745neoBLUE compact LED Phototherapy SystemLBI2016-12-12
3390081251971318K160305neoBLUE® LED Phototherapy SystemLBI2016-05-27
2122401062647528K153041Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional LabelingJXG2016-03-14
2122401233753583K152897Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating AccessoryJXG2016-03-04
2122401118846402K152481DURAFORM Dural Graft ImplantGXQ2015-10-30
97621385400763K151873Etest Ceftaroline (0.002 - 32ug/ml)JWY2015-10-07
97611976518095K151688chromID MRSAJSO2016-03-11
3390081607419408K151504ICS ImpulseGWN2015-11-16
526281278077136K141515AED HYSTEROSCOPE AND ACCESSORIESHIH2015-01-07
3390081790566845K141446ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER,GWJ2014-08-22
516321532723678K141348VISCO SOFT CONTACT LENSLPL2015-06-22
97601256878460K141133VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion IILYR2015-07-09
2122401362815679K133754INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTERGWM2014-03-06
3390081449752607K132957MADSEN ACCUSCREEN TYPE 1077GWJ2014-02-27
124941981099740K132291NAMSA CHEMICAL PROCESSJOJ2014-05-20
3390081708415446K122550ICS IMPULSEGWN2013-02-01
3390081106816766K122067TYPE 1077 ACCUSCREENGWJ2012-09-27
3390081494341921K122028AURICAL HITETW2012-10-23

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JWY602026-04-21
JXG202016-10-28
GWJ62024-03-08
GWM62014-03-06
JSO42018-07-06
GWN32025-02-14
LBI32018-12-13
KZE31998-03-04
GYK31993-08-23
QBN22022-03-15
EOB22017-08-01
PEX22017-07-22
ETY22016-09-01
ETW22012-10-23
NGZ22009-11-02
GEI22008-09-29
MQK22008-08-13
LTX22000-11-08
JJE21993-02-12
DEW21989-04-18
LCX12024-01-26
DQA12023-05-04
HKI12021-04-13
LCP12017-10-12
PTJ12017-04-27
PQZ12017-01-27
GXQ12015-10-30
LYR12015-07-09
LPL12015-06-22
HIH12015-01-07
JOJ12014-05-20
FJL12010-12-30
FLL12010-07-21
GAR12008-07-15
EWO12008-07-14
HAE12003-02-07
HBG12002-11-12
LOS12000-04-10
FAJ11999-12-15
GCJ11999-12-06

NDC#

200 records. Showing 1-40. Next

PMA#

PMN#

200 records. Showing 1-40. Next

Applications#

112 records. Showing 1-40. Next