FDA.reportPublic FDA data

NATCO

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10622021000511279NATIONAL VISION, INC.1Y2026-01-01296 Grayson Hwy LAWRENCEVILLE GA US 30046
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
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
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
96170323002806485Nathan Carrington1N2026-01-011 Becton Dr Franklin Lakes NJ US 07417
96809133006610063Nate Thomas1N2026-01-011 Brasseler Blvd Savannah GA US 31419
97103883003445500NATIONAL THERAPY PRODUCTS INC.1N2026-01-01420 Deerhurst Drive Unit 3 Brampton Ontario CA L6T 5H9
30036317443003631744NATUREPLEX LLC1N2026-01-0111085 Airport Rd Olive Branch MS US 38654
30044150143004415014NATEC MEDICAL LTD1N2026-01-01Ava Technopark, Med tech road, Cote DOr Technopole, Minissy, Cot Moka MU 80829
30047844163004784416Nathan Rosenberg1N2026-01-01381 Pearsall Ave Cedarhurst NY US 11516
30055812703005581270Natus Manufacturing Limited1N2026-01-01IDA BUSINESS PARK GORT, Co. Galway IE --
30065502243006550224NATEC MEDICAL LTD (Maurister)1N2026-01-01MEDIA BUILDING-GEOFFREY ROAD BAMBOUS Riviere du Rempart MU 90104
30074564543007456454NATURS DESIGN, INC1N2026-01-01274 W Cortland St Jackson MI US 49201
30081561403008156140Nathan Li1N2026-01-0111 Oakland St Lexington MA US 02420
30082499223008249922Nathan Hardesty1N2026-01-01595 Anglum Rd Bldg. 1, 2nd Flr Hazelwood MO US 63042
30084855843008485584National Vision, Inc.1N2026-01-013400 Energy Drive Saint Cloud MN US 56304
30093075983009307598Nathan Hardesty1N2026-01-01595 Anglum Rd Bldg. 1, 2nd Flr. Hazelwood MO US 63042

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1132241074675592P120014BIOMERIEUX THXID BRAF ASSAY KITOWD2013-05-29
526281373025996K993689AED CYSTOSCOPEFAJ1999-12-15
526281926335817K993688AED LAPAROSCOPEGCJ1999-12-06
97621047790559K992993ETEST FOR QUINUPRISTIN/DALFOPRISTINLTX1999-11-16
526281774773226K991656AED ARTHROSCOPEHRX1999-12-02
275951370452414K991120VACUTAINER BRAND CTAD TUBE (MULTIPLE)JKA1999-05-19
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
275951934270842K981013VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBEJKA1998-06-17
97622020091081K980348ETEST VANCOMYCINJWY1998-05-29
97621780085862K980345ETEST CEFTRIAXONEJWY1998-05-27
97621264994980K980342ETEST CHLORAMPHENICALJWY1998-05-29
97621453900822K980338ETEST OFLOXACINJWY1998-05-28
812411407419350K980082J-TIP NEEDLESS INJECTORKZE1998-03-04
1501501296659478K973442TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODESIKT1997-11-20
812411220877092K973254J-TIP INJECTORKZE1997-11-24
1501501240214993K971914TECA NCS ELECTRODE SYSTEM 2000GXY1998-03-26
2122401611264281K971799PRECISION FLOW OSV IIJXG1998-02-06
97621978991899K971697ETEST FOR LEVOFLOXACINJWY1997-07-14
97621695768081K971694ETEST FOR CEFTAZIDIMEJWY1997-06-30
275951153190055K971449VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)GIM1997-06-17
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
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
275951186297726K953994SEDITAINER* ERYTHROCYTE SEDIMENTATION RATE (ESR) SYSTEMJKA1995-09-26
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
1501501847126981K944547DANTEC KEYPOINTGWF1995-09-19
97622024019817K935519ETEST FOR AMPICILLIN/SULBACTAM 2/1JWY1994-11-04
1501501095180731K934580DANTEC 13R45 BAR ELECTRODEGXY1994-09-26
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
2122401310138223K914735VENTRICULAR PRESSURE MONITORING KIT, MODEL 110-4HMGWM1992-01-17
97621382785368K913459THE E TEST, MODIFICATIONJWY1991-09-25
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
1501501759679407K874735DANTEC 13L35/36/37 STIM. AND RECORDING ELECTRODEGXY1988-01-22
2122401754520275K861377STANDARD/PEDIATRIC CORDIS HYDROCEPHALUS VALVESJXG1986-06-19
1501501091565059K850108EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEGGXY1985-04-11
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
275951450062314K260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesJKA2026-04-15
630311357466279K251915Amethyst HP PTA OTW 0.035 CatheterLIT2025-12-18
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
1501501826724613K243495Natus Ultrapro S100 (982A0594)GWF2024-12-12
1501501967963818K242346Grass® MR Conditional/CT Cup ElectrodesGXY2024-08-29
3390081750919494K242198ICS Dizcovery (1091)GWN2025-02-14
630311074669822K241040Amethyst HP PTA OTW 0.035 CatheterLIT2024-12-18
3390081059094408K233649ALGO Pro Newborn Hearing Screener (ALGO Pro)GWJ2024-03-08
97621404246335K232395ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUDJWY2023-10-05
275951183062595K231373BD Vacutainer® K2 EDTA Blood Collection TubesJKA2024-02-02
630311747393191K220410Ebony HP PTA OTW 0.035 CatheterLIT2022-06-29
275951437594065K220212BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached HolderJKA2023-03-24
275951425832178K213670BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection TubesGIM2023-08-25
275951302585476K212724BD Vacutainer UltraTouch Push Button Blood Collection SetJKA2022-02-04
97621955519805K212461VITEK MS PRIMEQBN2022-03-15
97621375712980K210757ETEST Fosfomycin (FO) (0.032-512 µg/mL)JWY2021-11-12
630311476243767K210012Tamarin Blue PTCA RX Dilatation CatheterLOX2021-07-09
3390081509260693K203500RetCam EnvisionHKI2021-04-13
275951193812654K202446BD Preset Syringe & BD A-Line SyringeJKA2020-09-25
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
3486001621073952K180828Natureplex Warm Touch Warming JellyNUC2018-12-20
1501501684267904K173815Allergan Botox Needle ElectrodeIKT2018-06-29
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
97611072208669K163042chromID Strepto B agarPQZ2017-01-27
97621076966828K162950VITEK MSPEX2017-07-22
2122401809559173K162437Codman EDS3 CSF External Drainage SystemJXG2016-10-28
97621004075417K162385RAPIDEC CARBA NPPTJ2017-04-27
1302861479660502K162076chromID MRSAJSO2016-10-25
2122401447822492K161992Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt SystemsJXG2016-09-22
3390081487501581K161707Madsen ZodiacETY2016-09-01
1501501409301406K161430Myoject Luer Lock Needle ElectrodeIKT2017-03-02

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JWY602026-04-21
JXG202016-10-28
JKA132026-04-15
LIT92025-12-18
GXY62024-08-29
GWJ62024-03-08
JSO62018-07-06
IKT62018-06-29
GWM62014-03-06
GWN32025-02-14
LOX32021-07-09
LBI32018-12-13
KZE31998-03-04
GYK31993-08-23
GWF22024-12-12
GIM22023-08-25
QBN22022-03-15
EOB22017-08-01
PEX22017-07-22
ETY22016-09-01
ETW22012-10-23
LNH22009-11-10
NGZ22009-11-02
GEI22008-09-29
LTX22000-11-08
JJE21993-02-12
DEW21989-04-18
HKI12021-04-13
NUC12018-12-20
PTJ12017-04-27
PQZ12017-01-27
GXQ12015-10-30
PJE12015-09-09
LYR12015-07-09
LPL12015-06-22
HIH12015-01-07
GZL12014-12-12
JOJ12014-05-20
LGZ12013-10-03
OWD12013-05-29

NDC#

200 records. Showing 1-40. Next

PMA#

PMN#

200 records. Showing 1-40. Next

Applications#