FDA.reportPublic FDA data

ELITE

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
17179661717966ELITechGroup Inc1Y2026-01-01370 West 1700 South LOGAN UT US 84321
20288101000135616ELITE ORTHOPAEDICS, INC.1N2026-01-011535 SANTA ANITA AVE. South El Monte CA US 91733
30026498263002649826ELITE MANUFACTURING1N2026-01-01692 nanticoke creek pkwy Jarvis Ontario CA N0a 1j0
30035402363003540236ELITechGroup MDX LLC.1Y2026-01-0121720 23rd Dr SE, Suite 150 Bothell WA US 98021
30047438153004743815ELITE CUSTOM SOLUTIONS1N2026-01-012450 Marion rd Se Rochester MN US 55904
30049451383004945138ELITE MEDICAL INSTRUMENTS, INC1Y2026-01-01646 S State College Blvd Fullerton CA US 92831
30053257903005325790ELITE SURGICAL SUPPLIES (PTY) LTD1N2026-01-0154 De Havilland Crescent, Persequor Technopark Persequor Pretoria Gauteng ZA 0020
30097121133009712113Elite Biomedical Solutions LLC1N2026-01-01756 CINCINNATI BATAVIA PIKE STE C Cincinnati OH US 45245
30098826753009256700Elite Medical, LLC1N2026-01-018415 Wolf Lake Dr Bartlett TN US 38133
30133757233013375723ELITE MEDICAL SUPPLY OF NEW YORK, LLC1N2026-01-0140-C Industrial Park Drive Hendersonville TN US 37075
30175286213017528621Elite Medical, LLC1N2026-01-017420 Goodlett Farms Pkwy Cordova TN US 38016
30175650943017565094Elite Medical, LLC1N2026-01-014001 Helton Drive Florence AL US 35630
30176651333017665133ELITE SAFETY PRODUCTS, INC.1Y2026-01-01820 Echelon Ct City of Industry CA US 91744
30249461943024946194ELITE DENTAL LAB1N2026-01-01Tai Dong Science Park, Building 5, 4th Floor, Suite 1, Dayawan W Huizhou City Guangdong CN 516083
30306913713030691371ELITE BRITE1Y2026-01-01240 HERODIAN WAY SE, # 220 Smyrna GA US 30080
30443203593044320359ELITechGroup Inc., Tucson1N2026-01-013950 S. Country Club Rd. Suite #470, L Tucson AZ US 85714
00ELITE TEXTILE TRADING LLC5Y2020-04-25300 Spectrum Center Drive Suite 400 Irvine CA US 92618
30050362843005036284ELITE EYEWEAR CO.1N2020-04-25RM. 15A-02 XUEYUAN BLDG XUEYUAN ROAD, WENZHOU Zhejiang CN 325000
30067487793006748779ELITE OPTICAL INTL. LTD1N2020-04-25SHI CHONG INDUSTRIAL DISTRICT SHI PAI DONGGUAN Guangdong CN --
30070644743007064474ELITE DENTAL LAB1N2020-04-254F, Block 10C, Huafeng Science Park Fengtang Ave, Tangwei, FuYong, BaoAn District, Shenzhen Guangdong CN 518103
30092412903009241290ELITE MEDICAL (NANJING) CO., LTD.1N2020-04-25Rm.909, Block B, 62 Yuan Jiang Road Nanjing Jiangsu CN 210036
30095135633009513563Elite Medical Supply of New York1N2020-04-251900 Ridge Rd West Seneca NY US 14224
30114054963011405496ELITE MEDICAL LLC1Y2020-04-258222 118th Ave Ste 610 Largo FL US 33773
30137229033013722903ELITE DENTAL PRODUCTS1N2020-04-2510408 W State Road 84 Ste 103 Davie FL US 33324
30165607683016560768Elite Surgical Instruments Downtown LA1Y2020-04-252200 East 11th St Los Angeles CA US 90021

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2091421572087336K983305SCI-PHARM DESENSITIZING VARNISHLBH1998-12-17
328021165302587K863395WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZERCGZ1988-05-24
328022065332837K853973WESCOR MODEL 3700 WEBSTER SWEAT INDUCERKTB1985-10-16
3493621313462725K240854Accelerate Arc SystemQNJ2024-09-26
1432471902974620K220695Elite Biomedical Solutions Dose Request CordMRZ2022-04-29
869351949993960K200523Biolign® Roto-Loc Cervical Plate SystemKWQ2020-04-30
328022043695790K180627Macroduct Advanced Model 3710KTB2018-07-27
1089821764419289K180559HSV 1 & 2 ELITe MGB Kit; ELITe InGeniusPGI2018-10-29
2091421438106572K150696Jade 37% Phosphoric Acid Etchant GelKLE2015-06-23
2554751743937976K150612Annuy Latex Patient Examination Glove (powdered and powder-free); Annuy Nitrile Patient Examination Glove (powdered and powder-free)LYY2015-11-16
1089821536595845K132468MRSA/SA ELITE MGB, ELITE MGB SOFTWARENQX2013-10-17
869351600377778K130274BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEMMAX2013-10-29
328021345106223K121823CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRICJFS2013-03-27
1089821175636932K112937MRSA/SA ELITE MGBNQX2012-06-01
1432471820301162K110535ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTIONFRN2012-03-26
2091421664135971K102836BONASIL A+ IMPRESSION MATERIALSELW2011-01-13
1089821397365503K083430REAL-TIME PCR INTERNAL CONTROL 2B SETOLD2009-01-15
869351467550530K080075MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEMMNI2008-01-28
869351358183411K063453VERTEFIX PEDICLE SCREW SPINAL SYSTEMMNI2007-08-30
1385991750655417K042881PMD-2000 INTERFERENTIAL STIMULATORIPF2004-11-18
2009881750655417K042881PMD-2000 INTERFERENTIAL STIMULATORIPF2004-11-18
328021202784444K032608GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETERJIS2003-10-21
328021205576649K031539HEMOGLOBIN A1C REAGENT SETLCP2003-08-06
328021711617286K010031NANODUCT NEONATAL SWEAT ANALYSIS SYSTEMKTB2001-03-20
1772641014046577
1772641019733539
1772641042879585
1772641045206150
886711057929000
1772641061313196
886711063522067
1772641067250136
328021070327260
1772641086087125
1772641087703728
685491098872677
1772641099063114
1772641099740407
1772641109976077
1772641119852899
1772641128789223
1772641140743652
886711166036871
1772641216280878
1772641241581176
1772641243599050
1772641253978818
1772641268391728
1772641271062586
1772641273023705
1772641282144896
1772641288579967
1772641299173027
1772641329352486
1772641341802341
1772641368261452
1772641379254656
1772641394058659
1772641395779879
1772641399142628
667781427260336
1772641430494003
1772641455366414
1772641465286212
1772641502973203
2091421514008053
886711523076870
1772641529876273
1772641531053422
1772641557794414
1772641560837571
886711568517768
1772641571064068
1772641602708440
886711609784960
1772641619543600
1772641625045699
1772641634344215
1772641646953749
1772641680299629
1772641691278211
1772641695607200
1772641713385529
1772641714946522
1772641716426181
1772641732374818
1772641733053656
1772641734469880
886711741301865
1772641743380856
1772641743399803
1772641752774709
886711775317929
886711781253783
1772641801339503
1772641804148700
1772641805729341
1772641809116254
1772641813710385
1772641822000700
1772641824204718
1772641850699203
1772641854069092
1772641864271568
1772641892885105
1772641898501222
1772641910806490
1772641918611129
1772641924785043
328021926202927
1772641928192041
685491932451403
1772641933325805
1772641952426970
667781954736838
1772641956828773
1772641964811155
1772641991866722
886711999790463
1772642001957173

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KTB32018-07-27
NQX22013-10-17
MNI22008-01-28
IPF22004-11-18
QNJ12024-09-26
MRZ12022-04-29
KWQ12020-04-30
PGI12018-10-29
LYY12015-11-16
KLE12015-06-23
MAX12013-10-29
JFS12013-03-27
FRN12012-03-26
ELW12011-01-13
OLD12009-01-15
JIS12003-10-21
LCP12003-08-06
LBH11998-12-17
CGZ11988-05-24

NDC#

55 records. Showing 1-40. Next

PMN#

Applications#

GUDID#

80 records. Showing 1-40. Next