FDA.reportPublic FDA data

NA

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
NATIONAL PRESICION TOOL COMPANY, INC. / ROITBURG5N2026-01-0124 Sherwood Ln Fairfield NJ US 07004
Nathan Monin5N2026-01-012201 Bailey Ave Buffalo NY US 14211
NATERA INC.5N2026-01-01201 Industrial Rd Ste 410 San Carlos CA US 94070
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
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 JP 5300001
96108653002806350Naomichi Kawasaki1N2026-01-015960 Inglewood Dr Ste 200 Pleasanton CA US 94588
96121973002807554Natus Medical Denmark ApS1N2026-01-01Hoerskaetten 9 TAASTRUP Hovedstaden DK DK-2630
96146863003340029NAKAMURA DENTAL HANDPIECE MFG. CO., LTD.1N2026-01-0159-2 MINAMI-CHO ITABASHI-KU Tokyo JP 173-0027
96150373003261083Nathan 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
3511651208271130P260004Signatera™ CDxPQP2026-05-15
381281843075132K993881GENX CULTURE DISHMQK2000-02-14
526281373025996K993689AED CYSTOSCOPEFAJ1999-12-15
526281926335817K993688AED LAPAROSCOPEGCJ1999-12-06
430691074194855K993616CARDIO-CARD INTERPRETATION SYSTEM ILOS2000-04-10
526281774773226K991656AED ARTHROSCOPEHRX1999-12-02
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
2122401857378106K964923CODMAN LUMBAR DRAINAGE CATHETER KITJXG1997-06-25
2122401770324098K962928COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/)GWM1996-12-20
430691347955126K960544CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEMDRT1996-08-07
2122401016658295K960159CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS)JXG1996-10-25
2122401837910908K955832CORDIS VENTRICULAR ANTECHAMBER (VA)JXG1996-03-25
2122401274145477K954021EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II)JXG1995-10-24
2122401229967970K950315CORDIS CSF RESERVOIRLKG1995-05-09
2122401096860316K944595CORDIS HORIZONTAL-VERICAL VALVE SYSTEMJXG1995-10-19
2122401190308639K932273CORDIS TUNNELERGYK1993-08-23
2122402026442823K925810CORDIS POLYPROPYLENE BURR HOLE RESERVOIRJXG1994-03-02
97601808495193K923579MINIVIDAS 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
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
2122401039652435K895868HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSEGYK1989-10-31
97601689820147K891385VITEK 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
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
766201902513409K221798Finger Pulse Oximeter, Model: X1906PDQA2023-05-04
3390081509260693K203500RetCam EnvisionHKI2021-04-13
3390081708243813K182178neoBLUE blanket LED Phototherapy SystemLBI2018-12-13
526281762863451K170285AED SinuscopeEOB2017-08-01
2122401809559173K162437Codman EDS3 CSF External Drainage SystemJXG2016-10-28
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
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
2122401931539437K121573INTEGRA CAMINO ICP MONITORGWM2012-09-10
2122401469956739K121159INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTERGWM2012-07-20
3390081129943728K110286GN OTOMETRICS TYPE 1053 FREEFITETW2011-04-28
2122401991843813K102875CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; CGWM2010-12-20
526281146172204K102663AED RESECTOSCOPEFJL2010-12-30
2122401691581351K101381HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMSJXG2011-07-07
766201569662056K101043ECT DIGITAL THERMOMETERFLL2010-07-21
526281109537060K081553AED BIPOLAR FORCEPS, MODEL 13-1646GEI2008-09-29
526281031987637K081503AED MONOPOLAR LAP ACCESSORIESGEI2008-09-25
771891546254262K081366KUMAR T-ANCHORS HERNIA SETGAR2008-07-15
3390081965088206K081234GN OTOMETRICS INSERT EARPHONESEWO2008-07-14
526281406394261K080622ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105EOB2008-04-02
381281100825644K080395SUNIVF DISHESMQK2008-08-13
3390081336256371K073665ALGO 5 NEWBORN HEARING SCREENERGWJ2008-01-25
492361661253636K073652ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLEEFB2008-03-20
2122401216605962K061568CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738JXG2006-09-29
2122401817538642K033698CONTOUR-FLEX VALVE AND SHUNT SYSTEMJXG2003-12-17
3390081522937231K033645OTOFLEX 100 TYE 1012ETY2004-03-31
3390081945818759K030823ALGO 3I NEWBORN HEARING SCREENERGWJ2003-04-09
526281838266365K023868DAN KERRISON RONGEURS, MODELS K1 + BILLY 1HAE2003-02-07
2122401234615450K022712HAND DRILL, MODEL 11-9901-7HBG2002-11-12
381281044839005
381281246312235
381281257583983
766201272554447
381281332811882
766201338273396
381281407228532
124941422956610
124941618799859
766201798109857
766202006303015
526281000572556
441771010392375
441771013139579
526281018982487
526281032903179
3507101042604972
526281043146695
124941043590499
526281046694595
270531051553217
526281064557670
124941067807480
526281085803116
412181089966310
526281092031187
516321093630072
3507101095493801
526281101056799
3507101105165723
3469191107527317
124941108168811
124941113034044
3507101120862940
3507101125520584
766201130770485
766201136707787
2122401192998598

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JXG202016-10-28
GWJ62024-03-08
GWM62014-03-06
GWN32025-02-14
LBI32018-12-13
KZE31998-03-04
GYK31993-08-23
EOB22017-08-01
ETY22016-09-01
ETW22012-10-23
GEI22008-09-29
MQK22008-08-13
LCX12024-01-26
DQA12023-05-04
HKI12021-04-13
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
EFB12008-03-20
HAE12003-02-07
HBG12002-11-12
LOS12000-04-10
FAJ11999-12-15
GCJ11999-12-06
HRX11999-12-02
DXN11998-02-20
GBZ11997-12-17
DRT11996-08-07
LKG11995-05-09
JJE11993-02-12
CCK11992-08-14
DPS11992-07-09
DEW11989-04-18

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

200 records. Showing 1-40. Next

PMA#

PMN#

TAP2D

2026-02-02

Nano-X Imaging , Ltd.

200 records. Showing 1-40. Next

Applications#

112 records. Showing 1-40. Next