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#

200 records. Showing 1-40. Next

PMA#

PMN#

200 records. Showing 1-40. Next

Applications#

200 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next