FDA.reportPublic FDA data

INTELLIGENT HEARING SYSTEMS CORP.

Matched from indexed company URL: INTEL CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10527231000113738INTELLIGENT HEARING SYSTEMS CORP.1N2026-01-016860 Sw 81st St MIAMI FL US 33143
96159163003768392INTELERAD MEDICAL SYSTEMS INCORPORATED1N2026-01-01800, Boul. de Maisonneuve Est 14th floor MONTREAL Quebec CA H2L 4L8
30098621263009862126INTELLIGENT SYSTEMS CO LTD1N2026-01-016317-1 Umehara Nanto Toyama JP 939-1716
30115207293011520729INTELLIGENT RETINAL IMAGING SYSTEMS, INC.1N2026-01-012 North Palafox Suite 200 Pensacola FL US 32502
30129939473012993947INTELLIGENT FINGERPRINTING LIMITED1N2026-01-0114-17 Evolution Business Park Milton Road Cambridge Cambridgeshire GB CB24 9NG
30193564093019356409INTELIVATION TECHNOLOGIES, LLC1Y2026-01-01500 S Gravers Rd Suite 200 Plymouth Meeting PA US 19462
30224358403022435840Intelerad USA1Y2026-01-01305 Church at N Hills St, 6th Floor Raleigh NC US 27609
30232288373023228837Intelimas Corporation1N2026-01-0120 North Weymouth Avenue Londonderry NH US 03053
30271149333027114933Intelligent Healthcare Systems, Corp1Y2026-01-01700 Kinderkamack Rd Suite 300 Oradell NJ US 07649
30355450843035545084INTELON OPTICS1N2026-01-01331 Montvale Ave Fl 5 Woburn MA US 01801
30445194523044519452INTELLIGENT GALAXY LLC1Y2026-01-01120 S Palm Dr Winnabow NC US 28479
30061738993006173899INTELLEWAVE, Inc1N2020-04-25238 Rockaway Ave Floor 2 Valley Stream NY US 11580
30103909393010390939INTELOMED, INC.1N2020-04-256041 WALLACE ROAD EXT STE 110 Wexford PA US 15090
30111213673011121367INTELLIGENT IMPLANT SYSTEMS1N2020-04-253300 Intl Airport Dr STE 1100 Charlotte NC US 28208
30113244033011324403Intelligent Endoscopy1N2020-04-254740 Commercial Park Ct Ste 1 Clemmons NC US 27012

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
G079100140712S1Advantage C Cervical Interbody Fusion Device - 1001.40712S9124342780contact@intelivationtech.com
G079100150706S1Advantage C Cervical Interbody Fusion Device - 1001.50706S9124342780contact@intelivationtech.com
G079C2520000650Golden Isles Pedicle Screw System - Curved Titanium Rod9124342780contact@intelivationtech.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
421411234579140K964426SMARTOAEEWO1997-02-03
421411285089180K925648SMART-SCREENER (AUDITORY)GWJ1993-05-11
421411751829249K914876OPTI-AMPGWL1992-01-10
421411337207245K904926SMART-EPGWJ1991-08-02
421411614992525K900096INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA)EWO1990-05-31
2933781241553291K231147Hammerdesis™ Interphalangeal Fusion SystemHTY2023-09-14
3368071857526070K223700BOSS™MXK2024-08-16
3073561514869763K212578Nitrile disposable examination glovesLZA2021-12-02
2933781943881473K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFMAX2021-10-29
2933781702903197K212185Golden Isles Pedicle Screw SystemNKB2021-08-19
2933781592915271K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceODP2021-08-24
3073561592455714K211484Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety NeedlesMEG2022-03-01
3073561386295472K201634RG 3ml Medication CartridgeMRZ2021-03-26
3073561397808524K193657Disposable Enteral Feeding Syringe with Enfit ConnectorPNR2020-09-12
3049091731388649K192176IntelePACSLLZ2020-04-02
573551731388649K192176IntelePACSLLZ2020-04-02
1833141929145358K173935Mediant Anterior Cervical Plating SystemKWQ2018-04-16
421411023416726K163326SmartEPGWJ2017-09-29
1833141128846057K163056Revolution™ Spinal Fixation SystemNKB2017-02-24
3073561272090696K162601Infusion Set for Single UseFPA2017-05-31
1833142003091960K160216Revolution Spinal Fixation SystemNKB2016-04-22
3049092047815943K152949WebPAXLLZ2016-08-17
3073561206765487K152197Skypro, SP01 MaskFXX2016-08-26
3073561124468051K151151U & U Intravascular Administration SetFPA2015-09-24
573552003688693K150707IntelePACSLLZ2015-05-27
1833141999112542K142939Revolution Spinal Fixation SystemNKB2015-01-13
1812031001680883K141922IRIS INTELLIGENT RETINAL IMAGING SYSTEMNFJ2015-02-27
3049091496889099K123466HEALTHVIEW ECG MANAGERDQK2012-12-20
3073561646072291K121152SURGICAL GOWN, SMSFYA2012-12-12
3049091601373711K120514CARDIOPACSLLZ2012-07-05
1612151687305424K120052CVINSIGHTDQA2012-09-04
3073561441450810K112136TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPEKKX2011-09-29
3073561935442590K111067JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILEFYA2011-08-02
3073561651569588K093910IMPROVACUTER GEL & CLOT ACTIVATOR TUBEJKA2010-07-12
421411863082053K090579SMARTSCREENER-PLUS2GWJ2009-07-07
421411471649698K073384SMART COUPLER, MODEL M015401GWJ2008-02-28
421411186861498K070608SMARTEP, MODEL M010000GWJ2007-07-18
421411866940895K063402WICK ELECTRODE, MODEL M019260GXY2006-12-11
670341301824215K062068INTELWAVE HEART RATE VARIABILITY SYSTEM, VERSION 1.0DPS2006-10-27
2933782071936106K061798BIOPRO MEMORY STAPLEJDR2006-08-21
421411119348167K061443SMART USBLITE, MODEL M011120GWJ2006-06-23
421411406500794K052060OPTI-AMP DC-POWEREDGWL2005-08-31
421411279579564K031051SMARTEP-ASSR, MODEL M811007GWJ2004-02-20
421411586010425K023859SMARTTROAEEWO2003-01-08
3073561871390330K020474MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95MSH2002-07-23
2933782037104375K012990COLLATEK POWDERKGN2001-10-24
3073562064888547K001858OPERATING ROOM TOWEL, STERILE, COLORS BLUE OR WHITEKKX2000-08-17
1779981010280192
2105761511859828
1779981541122115
1779982071118076
3073561057027653
2933781085105818
2933781120211947
2933781124277734
2933781157385599
2933781177435940
2933781211164386
3073561293371254
2933781296227432
421411297714990
3073561318997529
421411324376661
2933781351648258
2933781355904662
2933781386663068
3073561396740457
2933781421347727
3073561442470950
2933781481524017
2933781483903647
2933781490379017
1644561508230974
2933781541013290
2933781584097294
2933781650802799
3073561710485778
3073561723429062
421411778346334
2933781904286828
2933781913396215
3073561943216552
2933781953495797
3073562023853302
3049092029011970
421412044739152

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GWJ82017-09-29
LLZ52020-04-02
NKB42021-08-19
EWO32003-01-08
FPA22017-05-31
NFJ22015-02-27
FYA22012-12-12
KKX22011-09-29
GWL22005-08-31
MXK12024-08-16
HTY12023-09-14
MEG12022-03-01
LZA12021-12-02
MAX12021-10-29
ODP12021-08-24
MRZ12021-03-26
PNR12020-09-12
KWQ12018-04-16
FXX12016-08-26
DQK12012-12-20
DQA12012-09-04
JKA12010-07-12
GXY12006-12-11
DPS12006-10-27
JDR12006-08-21
MSH12002-07-23
KGN12001-10-24

NDC#

PMN#

BOSS?

2024-08-16

Intelon Optics, Inc.

Reverso

2021-11-10

Intelis Instruments Ltd.

IntelePACS

2020-04-02

Intelerad Medical Systems Incorporated

SmartEP

2017-09-29

INTELLIGENT HEARING SYSTEMS

ELyx-PRO

2017-01-24

Intelligent Sensory Concept SA

IntelePACS

2015-05-27

INTELERAD MEDICAL SYSTEMS INCORPORATED

86 records. Showing 1-40. Next

Applications#

GUDID#

80 records. Showing 1-40. Next