FDA.reportPublic FDA data

NOVA

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10637503001668796NOVANTA MEDICAL USA, INC.1Y2026-01-01100 Paramount Dr Ste 101 Sarasota FL US 34232
12190291219029NOVA BIOMEDICAL CORPORATION1N2026-01-01200 Prospect St WALTHAM MA US 02454
17219641000117423NOVARAD CORP.1N2026-01-013152 North University Avenue Suite 200 Provo UT US 84604
20852493002329391NOVA ORTHO-MED, INC.1Y2026-01-01410 Smoketree Plaza Suite 100 North Aurora IL US 60542
24323201000521377NOVAMED-USA1Y2026-01-014 WESTCHESTER PLZ STE 137 Elmsford NY US 10523
96138463002807769NOVATECH S.A.1N2026-01-011058, VOIE ANTIOPE ZI ATHELIA 3 LA CIOTAT CEDEX Bouches-du-Rhone FR 13705
30027352383002735238NOVAFLUX, INC.1N2026-01-011 Airport Place Suite 1 Princeton NJ US 08540
30037689193003768919NOVABONE PRODUCTS, LLC1N2026-01-0113510 NW US Highway 441 ALACHUA FL US 32615
30041934893004193489NOVA BIOMEDICAL CORPORATION DIABETES PRODUCTS1N2026-01-0139 Manning Rd Billerica MA US 01821
30045317513004531751NOVA MEDICAL, INC1N2026-01-01150 WEST ST STE 201 Wilmington MA US 01887
30045942973004594297NOVAVISION, INC.1N2026-01-01951 BROKEN SOUND PKWY STE 320 BOCA RATON FL US 33487
30056415453005641545NOVA EYE INC.1Y2026-01-0141316 Christy St Fremont CA US 94538
30062188073006218807NOVABAY PHARMACEUTICALS, INC1Y2026-01-012000 Powell Street, Suite 1150 Emeryville CA US 94608
30076979083007697908Novapharm Research Australia Pty Ltd1N2026-01-013 - 11 Primrose Ave Rosebery New South Wales AU 2018
30101202173010120217NOVAPROBE INC.1N2026-01-0117 W 2ND ST, REAR Suite 1001 Lansdale PA US 19446
30104426933010442693Nova Instruments1N2026-01-01Unit 32 Space Business Centre Molly Millars Lane Berkshire Wokingham GB RG41 2PQ
30106737773010673777NOVASTEP1N2026-01-012 allee Jacques Frimot RENNES Bretagne FR 35000
30118082213011808221NOVA IMPLANTS LTD1N2026-01-015 Yoni Netanyahu street Or-Yehuda Tel Aviv IL 6037603
30119798583011979858Nova Biomedical Corporation1N2026-01-01165 Lexington Rd Billerica MA US 01821
30123451103012345110Novadaq Technologies ULC1N2026-01-018329 Eastlake Drive, Unit 101 Burnaby British Columbia CA V5A 4W2
30136018303013601830NOVA AVENTURA COMERCIO DE ARTIGOS ESPORTIVOS LTDA1N2026-01-01520, Cambacica Avenue suite 612 Campinas Sao Paulo BR 13097160
30140227933014022793NOVA VASCULAR INCORPORATION1Y2026-01-0125 Mauchly, STE 301 Irvine CA US 92618
30151688593015168859NOVASIGHT1N2026-01-011 Negev St Airport City Central IL 7019900
30195437953019543795NOVAERUS US INC.1Y2026-01-013540 Toringdon Way Ste 200 Charlotte NC US 28277
30203073033020307303NOVAPPROACH SPINE, LLC1N2026-01-0113900 Tech City Circle Suite 300 Alachua FL US 32615

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
00385480533980STATSTRIP - Statstrip Glucose Meter with Battery and Quick Reference Guide+1(800)545-6682info@novabio.com
00385480533997STATSTRIP - Statstrip Glucose Meter with Battery and Quick Reference Guide Remanufactured+1(800)545-6682info@novabio.com
00385480547901STATSTRIP - Statstrip Glucose Meter with Battery and Quick Reference Guide+1(800)545-6682info@novabio.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
300701975487245K993104STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATORGLY1999-12-02
210231634928944K992416PERIOGLAS- BIOGLASS BONE GRAFT PARTICULATELYC1999-10-15
300701883978766K982277MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991)CHL1998-07-22
300701746470380K980991NOVA STAT PROFILE PHOX BLOOD GAS ANALYZERCHL1998-04-15
152961243512174K971509ENDOXANENWA1997-08-21
300701458989581K963005NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)JFL1996-08-23
300701040999907K962997NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3JJY1996-08-15
300701044112889K962982NOVA CHEMISTRY CONTROLS, LEVEL 1,2,AND 3 W/O CREATJJY1996-08-23
210231610203348K962494PERIOGLAS - BIOGLASS BONE GRAFT PARTICULATELYC1996-09-20
300701041625614K955264NOVA CHEMISTRY CONTROLS, LEVELS 1 AND 2JJY1996-02-02
300701025739909K955260NOVA CHEMISTRY PERFORMANCE CHECK SOLUTIONJJY1996-02-02
300701313365480K955252NOVA CHEMISTRY LINEARITY SET F, LEVELS 1, 2, 3, AND 4JJY1996-02-02
300701094959471K955013NOVA CO-OXIMETER ANALYZERGLY1996-04-25
152961024980604K950965KARL STORZ STENT APPLICATOR FORCEPSEOQ1995-03-31
300701611850363K945584NOVA 16 ANALYZERJJC1995-02-08
152961129769563K943700KARL STORZ BRONCHOSCOPE ACCESSORIESEOQ1994-08-23
210231487720543K930115PERIOGLASSLYC1993-11-04
300701825246707K924864NOVA 13 ANALYZER, MODIFICATIONCGZ1992-11-06
300701637791427K924743NOVA 12 ANALYZER, MODIFICATIONCGA1992-11-06
300701111238330K924547NOVA 8 CRT ANALYZERJGS1993-01-28
300701104609068K923806ANALYZER: NOVA 10 CRT ANALYZER & QUALI CONT MATERJGS1992-09-29
300701691896377K922215NOVA 14 NA/K/CL/GLU/BUN ANALYZERJGS1992-07-17
300701436286001K915178NOVA 11 NA/K/LI ANALYZERCEM1992-01-27
300701952611174K915177NOVA 5 NA/K/C1 ALALYZERCEM1992-01-27
300701362919385K915176NOVA 4 NA/K/C1/TCO2/LI ANALYZERJGS1992-01-15
300701797852842K912561NOVA 13 ANALYZERCGZ1991-09-11
300701619989027K912560NOVA 12 ANALYZERJGS1991-07-17
300701703243504K912559NOVA 1 SODIUM/POTASSIUM/HEMATOCRIT ANALYZERJGS1991-07-01
1784891335818096K260274Airlock® Ankle Plating SystemHRS2026-03-25
152961046141612K243126TRACHEOBRONXANE™ DUMON®NWA2024-10-29
152961544279787K242324DUTAU-NOVATECH®EOQ2025-02-06
210231200031683K240404NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)MQV2024-03-05
300702066218161K232075StatStrip Glucose Hospital Meter SystemPZI2024-02-23
300732066218161K232075StatStrip Glucose Hospital Meter SystemPZI2024-02-23
1875692066218161K232075StatStrip Glucose Hospital Meter SystemPZI2024-02-23
2149181180223719K230727SPY Portable Handheld Imaging (SPY-PHI) SystemIZI2023-06-05
1784891868009791K230724arcad® 2.0 Duo & Quadro osteosynthesis compressive staplesJDR2023-12-04
1784891327659808K223468Nexis® compressive screwsHWC2023-08-30
2721532059891918K221872ITrack Advance Canaloplasty Microcatheter with Advanced Delivery SystemMPA2023-03-30
300701879055296K221813Nova Allegro UACR Assay, Nova Allegro AnalyzerCGX2024-11-19
2264691033310732K221375CureSight-CS100QQU2022-09-29
300701865403146K221326Nova Allegro HbA1c Assay, Nova Allegro AnalyzerLCP2024-11-22
210231045517478K220498NovoGen Wound MatrixKGN2023-06-09
431331230447336K220146VisAROLO2022-05-27
2961632018148754K211769OneLIF Intervertebral Body Replacement SystemOVD2021-09-07
300701223961062K203549Nova Primary Glucose Analyzer SystemCGA2022-10-18
2149182018473514K202244SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareOWN2020-11-05
2062521005688451K201615SIGNA 7.0TLNH2020-10-15
2149181602754692K200737SPY Portable Handheld Imaging (SPY-PHI) SystemOWN2020-05-21
2938191748070188K200321Novaerus NV1050FRF2020-12-28
1784891824020473K192356Airlock Centrolock Osteosynthesis Implant SystemHRS2019-12-14
2149181596579836K192174SPY Portable Handheld Imaging (SPY-PHI) SystemOWN2019-11-15
300701543467385K191626Stat Profile Prime ES Comp Plus Analyzer SystemJFP2019-08-16
300701771284210K191365Stat Profile Prime ES Comp Plus Analyzer SystemJGS2019-07-19
2149181722338774K190729SPY Portable Handheld Imaging (SPY-PHI) SystemOWN2019-04-19
2149181333740599K182907SPY Elite Intraoperative Perfusion Assessment SystemIZI2019-01-23
2062521623918114K1827373T 32 Channel Head CoilMOS2019-04-12
2149181945559014K182606PINPOINT Endoscopic Fluorescence Imaging SystemGCJ2018-11-21
300701999418786K180428Stat Profile Prime Plus Analyzer SystemJGS2018-08-15
300702029668379K180340Stat Profile Prime Plus Analyzer SystemCGA2018-09-26
300701581561107K180186Stat Profile Prime Plus Analyzer SystemGGZ2018-08-23
300702044737267K173797Stat Profile Prime Plus Analyzer SystemCHL2018-07-17
431331852953912K172418OpenSightLLZ2018-09-21
431331156610075K171754NovaPACSLLZ2017-07-28
152961346634730K170030NOVATECH TALCAIRGCJ2017-03-13
210231556773030K163310NovaBone IRMMQV2017-01-18
2149182002447612K162885SPY Phi Open Field Handheld Fluorescence Imaging SystemOWN2017-01-11
2149181574158689K161792PINPOINT Endoscopic Fluorescence Imaging SystemGCJ2016-09-20
300701630846438K160990Nova Max Uric Acid Monitoring SystemPTC2017-04-11
300731630846438K160990Nova Max Uric Acid Monitoring SystemPTC2017-04-11
1875691630846438K160990Nova Max Uric Acid Monitoring SystemPTC2017-04-11
300701887404199K160156StatStrip Xpress Blood Glucose Monitoring SystemNBW2016-06-23
300731887404199K160156StatStrip Xpress Blood Glucose Monitoring SystemNBW2016-06-23
1875691887404199K160156StatStrip Xpress Blood Glucose Monitoring SystemNBW2016-06-23
300701500109321K152986StatStrip Xpress 2 Glucose Hospital Meter SystemPZI2016-01-27
300731500109321K152986StatStrip Xpress 2 Glucose Hospital Meter SystemPZI2016-01-27
1875691500109321K152986StatStrip Xpress 2 Glucose Hospital Meter SystemPZI2016-01-27
300701904831724K151982Stat Profile Prime ABG Analyzer SystemCHL2015-09-10
152961597180762K151832NOVATECH TALCAIRGCJ2016-03-31
1784891185483514K151277Airlock® osteosynthesis plate systemHRS2015-08-13
2149181760970190K150956PINPOINT Endoscopic Fluorescence Imaging SystemGCJ2016-05-23
300701928616518K150461StatStrip Xpress Glucose Hospital Meter SystemPZI2015-05-20
300731928616518K150461StatStrip Xpress Glucose Hospital Meter SystemPZI2015-05-20
1875691928616518K150461StatStrip Xpress Glucose Hospital Meter SystemPZI2015-05-20
1848371459118586K150363NOVA Dental Implants SystemDZE2015-06-29
300701068884172K150281StatStrip Glucose Hospital MeterPZI2015-05-06
300731068884172K150281StatStrip Glucose Hospital MeterPZI2015-05-06
1875691068884172K150281StatStrip Glucose Hospital MeterPZI2015-05-06
1784891515005890K143523Airlock osteosynthesis plate systemHRS2015-04-06
1385921183958970K143351iCase Contact Lens CaseLRX2015-04-29
1784891987911312K143229Nexis osteosynthesis compressive screwsHWC2015-02-06
1784891588714402K143146Nexis osteosynthesis snap-off screwsHWC2015-02-06
1784891242292771K143049LYNC intramedullary implantHTY2015-02-19
210231236195002K142712Dental Collagen Wound Dressing (Nova Tape and NovaPlug)KGN2015-01-08
431331386564271K142698PerkinElmer, XRpad 4343 F MED Flat Panel DetectorMQB2014-10-23
300701614154284K142220Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators)CHL2014-10-17
1784891349602967K142111ARCAD COMPRESSIVE OSTEOSYNTHESIS STAPLE, EXPRESS COMPRESSIVE OSTEOSYNTHESIS STAPLEJDR2014-12-19
300701554300555K141907STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET ACHL2015-05-29
210231404575328K141207NOVABONE BIOACTIVE STRIPMQV2014-10-31
210231691838519K140946NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITEMQV2014-08-22
431331693664702K140551PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTORMQB2014-08-01
300701091831745K132121STATSTRIP GLUCOSE HOSPITAL METER SYSTEMPZI2014-09-24
300731091831745K132121STATSTRIP GLUCOSE HOSPITAL METER SYSTEMPZI2014-09-24
1875691091831745K132121STATSTRIP GLUCOSE HOSPITAL METER SYSTEMPZI2014-09-24
300701034979418K131703NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEMCHL2014-03-25
1385921798383559K131542NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTCFRO2013-07-24
1532851505997286K131226NOVAPROBE LED LIGHT SOURCEFCW2014-07-24
300701139998119K131013FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEMNBW2013-10-17

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MQV252024-03-05
CHL172018-07-17
NBW172016-06-23
PZI152024-02-23
LYC132011-12-16
CGA122022-10-18
JGS92019-07-19
IZI82023-06-05
HRS72026-03-25
GCJ72018-11-21
LFR62013-04-04
KHP62012-01-05
JJY62010-08-27
HWC52023-08-30
OWN52020-11-05
LLZ42018-09-21
DWJ42006-12-08
EOQ32025-02-06
JDR32023-12-04
KGN32023-06-09
MPA32023-03-30
PTC32017-04-11
FRO32013-07-24
CGL32007-05-07
NWA22024-10-29
HTY22015-02-19
MQB22014-10-23
FRG22008-12-05
CCW22007-02-09
BZT22006-09-05
JJX22004-05-07
EZL22002-09-23
KRI22002-05-03
GLY21999-12-02
CGZ21992-11-06
CEM21992-01-27
LCP12024-11-22
CGX12024-11-19
QQU12022-09-29
OLO12022-05-27

NDC#

Sandimmune

Novartis Pharmaceuticals Corporation

cyclosporine

Sandostatin

Novartis Pharmaceuticals Corporation

octreotide acetate

Sandostatin

Novartis Pharmaceuticals Corporation

octreotide acetate

Sandostatin

Novartis Pharmaceuticals Corporation

octreotide acetate

Sandimmune

Novartis Pharmaceuticals Corporation

cyclosporine

Sandimmune

Novartis Pharmaceuticals Corporation

cyclosporine

Neoral

Novartis Pharmaceuticals Corporation

cyclosporine

Neoral

Novartis Pharmaceuticals Corporation

cyclosporine

Femara

Novartis Pharmaceuticals Corporation

letrozole

Neoral

Novartis Pharmaceuticals Corporation

cyclosporine

Diovan HCT

Novartis Pharmaceuticals Corporation

valsartan and hydrochlorothiazide

Diovan HCT

Novartis Pharmaceuticals Corporation

valsartan and hydrochlorothiazide

Simulect

Novartis Pharmaceuticals Corporation

basiliximab

Trileptal

Novartis Pharmaceuticals Corporation

oxcarbazepine

Trileptal

Novartis Pharmaceuticals Corporation

oxcarbazepine

Diovan

Novartis Pharmaceuticals Corporation

valsartan

Diovan

Novartis Pharmaceuticals Corporation

valsartan

Diovan

Novartis Pharmaceuticals Corporation

valsartan

Lotrel

Novartis Pharmaceuticals Corporation

amlodipine besylate and benazepril hydrochloride

Ritalin

Novartis Pharmaceuticals Corporation

methylphenidate hydrochloride

Ritalin

Novartis Pharmaceuticals Corporation

methylphenidate hydrochloride

Ritalin

Novartis Pharmaceuticals Corporation

methylphenidate hydrochloride

Lotrel

Novartis Pharmaceuticals Corporation

amlodipine besylate and benazepril hydrochloride

Focalin

Novartis Pharmaceuticals Corporation

dexmethylphenidate hydrochloride

Focalin

Novartis Pharmaceuticals Corporation

dexmethylphenidate hydrochloride

Focalin

Novartis Pharmaceuticals Corporation

dexmethylphenidate hydrochloride

Diovan HCT

Novartis Pharmaceuticals Corporation

valsartan and hydrochlorothiazide

Myfortic

Novartis Pharmaceuticals Corporation

mycophenolic acid

Myfortic

Novartis Pharmaceuticals Corporation

mycophenolic acid

Simulect

Novartis Pharmaceuticals Corporation

basiliximab

Gleevec

Novartis Pharmaceuticals Corporation

imatinib mesylate

Lotrel

Novartis Pharmaceuticals Corporation

amlodipine besylate and benazepril hydrochloride

Lotrel

Novartis Pharmaceuticals Corporation

amlodipine besylate and benazepril hydrochloride

Zortress

Novartis Pharmaceuticals Corporation

everolimus

Zortress

Novartis Pharmaceuticals Corporation

everolimus

Zortress

Novartis Pharmaceuticals Corporation

everolimus

Zortress

Novartis Pharmaceuticals Corporation

everolimus

Diovan

Novartis Pharmaceuticals Corporation

valsartan

Ritalin

Novartis Pharmaceuticals Corporation

methylphenidate hydrochloride

Focalin

Novartis Pharmaceuticals Corporation

dexmethylphenidate hydrochloride

200 records. Showing 1-40. Next

PMA#

PMN#

VisAR

2022-05-27

Novarad Corporation

200 records. Showing 1-40. Next

Applications#

200 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next