FDA.reportPublic FDA data

NATCO

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
Nathan Monin5N2026-01-012201 Bailey Ave Buffalo NY US 14211
NATIONAL PRESICION TOOL COMPANY, INC. / ROITBURG5N2026-01-0124 Sherwood Ln Fairfield NJ US 07004
NATERA INC.5N2026-01-01201 Industrial Rd Ste 410 San Carlos CA US 94070
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

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3511651208271130P260004Signatera™ CDxPQP2026-05-15
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
2122401447822492K161992Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt SystemsJXG2016-09-22
3390081487501581K161707Madsen ZodiacETY2016-09-01
1501501409301406K161430Myoject Luer Lock Needle ElectrodeIKT2017-03-02
3390081921649998K160745neoBLUE compact LED Phototherapy SystemLBI2016-12-12

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
IKT62018-06-29
GWM62014-03-06
JSO42018-07-06
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
FJL12010-12-30

NDC#

Naturasil

Nature's Innovation, Inc.

PHOSPHORIC ACID

Naturasil

Nature's Innovation, Inc.

Phosphoricum Acidum

Naturasil

Nature's Innovation

Phosphoricum Acidum

Naturasil

Nature's Innovation, Inc.

Thuja Occidentalis

Naturasil

Nature's Innovation, Inc.

Thuja Occidentalis

Naturasil

Nature's Innovation, Inc.

Sulfur-Lavender

Naturasil

Natures Innovation, Inc.

SULFUR, THUJA OCCINDENTALIS

ACNE HP

Natural Creations, Inc.

Carbo Animalis, Activated Charcoal, Potassium Dichromate, Sodium Chloride, Pulsatilla Vulgaris, Sepia Officinalis Juice, Silicon Dioxide, Sulfur, Zinc

Allergy HP

Natural Creations, Inc.

Onion, Ambrosia Artemisiifolia, Arsenic Trioxide, Activated Charcoal, Euphrasia Stricta, Strychnos Nux-Vomica Seed, Pulsatilla Vulgaris, Solidago Virgaurea Flowering Top, Sulfur

Anxiety HP

Natural Creations, Inc.

Arsenic Trioxide, Calcium Carbonate, Strychnos Ignatii Seed, Potassium Carbonate, Lachesis Muta Venom, Sodium Chloride, Phosphorus, Pulsatilla

ANXIETY II HP

Natural Creations, Inc.

Aconitum Napellus, Arsenic Trioxide, Atropa Belladonna, Oyster Shell Calcium Carbonate, Crude, Activated Charcoal, Human Breast Tumor Cell, Causticum, Gelsemium Sempervirens Root, Lachesis Muta Venom, Mercury, Sodium Chloride, Nitric Acid, Phosphorus, Toxic...

Arthritis HP

Natural Creations, Inc.

Apis Mellifera, Bryonia Alba Root, Causticum, Colchicum Autumnale Bulb, Kalmia Latifolia Leaf, Ledum Palustre Twig, Pulsatilla Vulgaris, Rhododenron Aureum LEaf, Toxicodendren Pubescens Leaf

Bronchi HP

Natural Creations, Inc.

Activated Charcoal, Copper, Drosera Rotundifolia, Ipecac, Lachesis Muta Venom, Lobelia Inflata, Phosphorus, Pulsatilla Vulgaris, Rumex Crispus Root, Spongia Officinalis Skeleton, Roasted

Cough HP

Natural Creations, Inc

Arsenicum Album, Bryonia Alba, Cuprum Acenticum, Drosera Rotundifolia, Ipecacuanha, Kali Carbonicum, Phosphorus, Pulsatilla, Spongia Tosta

CYSTOGES HP

Natural Creations, Inc.

Berberis Vulgaris Root Bark, Lytta Vesicatoria, Clematis Recta Flowering Top, Canis Lupus Familiaris Milk, Lycopodium Clavatum Spore, Pulsatilla Vulgaris, Sarsaparilla, Sepia Officinalis Juice, Delphinium Staphysagria Seed

DIZZINESS HP

Natural Creations, Inc.

Oyster Shell Calcium Carbonate Crude, Chenopodium Ambrosioides, Anamirta Cocculus Seed, Conium Maculatum Flowering Top, Strychnos Nux-Vomica Seed, Phosphorus, Pulsatilla Vulgaris, Silicon Dioxide

ECZEMA HP

Natural Creations, Inc.

Arsenic Trioxide 30X, Oyster Shell Calcium Carbonate, Crude 30X, Graphite 30X, Mercurius Solubilis 30X, Daphne Mezereum Bark 30X, Toxicodendron Pubescens Leaf 30X, Sepia Officinalis Juice 30X, Sulfur 30X

FLU HP

Natural Creations, Inc.

Aconitum Napellus, Arsenic Trioxide, Atropa Belladonna, Bryonia Alba Root, Eupatorium Perfoliatum Flowering Top, Ferrum Phosphoricum, Gelsemium Sempervirens Root

HEADACHE HP

Natural Creations, Inc.

Silver Nitrate, Atropa Belladonna, Bryonia Alba Root, Gelsemium Sempervirens Root, Nitroglycerin, Lachesis Muta Venom, Lycopodium Clavatum Spore, Melilotus Officinalis Top, Sodium Chloride, Strychnos Nux-Vomica Seed, Silicon Dioxide, Spigelia Anthelmia

MENOPAUSE HP

Natural Creations, Inc.

Atropa Belladonna, Black Cohosh, Lachesis Muta Venom, Strychnos Nux-Vomica Seed, Pulsatilla Vulgaris, Claviceps Purpurea Sclerotium, Sepia Officinalis Juice, Ustilago Maydis

200 records. Showing 1-40. Next

PMA#

PMN#

RetCam Envision

2021-04-13

Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek)

Natus NeuroWorks

2020-05-18

Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)

Natus NeuroWorks

2018-03-14

Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)

Grass TWin

2018-03-09

Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)

Natus Quantum

2018-02-22

Natus Medical Incorporated DBA Excel_tech Ltd. (XLTEK)

Comet-PLUS

2017-11-03

Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)

Trex_HD

2016-11-04

Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)

200 records. Showing 1-40. Next

Applications#