FDA.reportPublic FDA data

Jan

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10667493003387922JANUS DEVELOPMENT GROUP, INC.1N2026-01-01218 E Arlington Blvd Ste C GREENVILLE NC US 27858
14504201450420JANIN GROUP, INC.1N2026-01-015509 Bagby Ave Waco TX US 76711
20306333000210620JANT PHARMACAL CORP.1Y2026-01-0116530 Ventura Blvd Ste 512 ENCINO CA US 91436
96127773001610754Janice Breen1N2026-01-01153 Industrial Blvd. PLATTSBURGH NY US 12901
30010650243001065024Janelle Herr1N2026-01-013718 Illinois Avenue Saint Charles IL US 60174
30037691203003769120Jan Maniscalco1N2026-01-01411 Newark Pompton Turnpike Wayne NJ US 07470
30064537903006453790JANZEN AND JANZEN CHIROPRACTIC CORPORATION1N2026-01-011501 Northeast 69th Street Oklahoma City OK US 73111
30069488633006948863Jane Hurst1N2026-01-01385 Garrisonville RD Ste 113 Stafford VA US 22554
30075438253007543825JANDTY HEALTH INC.1N2026-01-0119F., No.307, Sec. 2, Taiwan Blvd. West District Taichung TW 40360
30085938903008593890Janice Brown1N2026-01-01440 Cliff Rd Sewaren NJ US 07077
30093033343009303334Jane Flynn1N2026-01-01209 Johnson Rd Morris Plains NJ US 07950
30095961333009596133Jan Mao Industries Co., Ltd.1N2026-01-01No. 15, Yuanqu Avenue, Xin an Town, Pingguo City Guangxi Zhuang Autonomous Region Baise City Guangxi CN 531400
30100601573010060157JANCO, INC.1N2026-01-0150 Goodwin Road Rollinsford NH US 03869
30104453683010445368JANGTAE (BRANDON) YOO1N2026-01-01400 Kelby Street, Ste 1500 Fort Lee NJ US 07024
30118948413011894841Jane Metcalf1N2026-01-014 Cromwell Irvine CA US 92618
30123117743012311774Jane Campbell1N2026-01-01164 Hammock Ave. Pawleys Island SC US 29585
30136876303013687630Jane Campbell1N2026-01-01164 HAMMOCK AVE Pawleys Island SC US 29585
30143673183014367318Jane McGarry1N2026-01-0110 Westport Road Lobby A Building, 2nd Floor Wilton CT US 06897
30179838543017983854Jan Hochdoerffer1N2026-01-014217 E Cotton Center Blvd Ste 175 Phoenix AZ US 85040
30219853333021985333JANIE AND JACK LLC1Y2026-01-01225 Bush Street Suite 1300 San Francisco CA US 94104
30002075793000207579JAN CHARLES1N2020-04-2544 CROSBY STREET Sayville NY US 11782
30065549123006554912Jane Weber1N2020-04-2575 North Fairway Drive Vernon Hills IL US 60085
30077307383007730738Janet Cosgrove1N2020-04-2575 Panorama Creek Drive Rochester NY US 14625
30080445073008044507Janzen Lo1N2020-04-25137 wyndham dr Allentown PA US 18104
30119134713011913471JAN HAO INDUSTRIAL CO., LTD1N2020-04-25NO. 133, ALY. 125, LN. 318, SEC. 2, ANHE RD., ANNAN DIST., TAINAN Tainan - Municipality TW 70967

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1922751779163866P250024Trilogy Transcatheter Heart Valve SystemNPT2026-03-17
1097131111819106K992983BAHO AUTOCLAVABLE CYSTOSCOPEFAJ1999-10-07
402981123861465K992917AEROCHAMBER PLUS VALVED HOLDING CHAMBERCAF1999-09-14
520101923930408K991927MEDI-TEST COMBI 11JIL1999-09-17
520102063444170K990658
520101829746179K984079INSTANT-VIEW PREGNANCY URINE DIP-STRIP TESTJHI1999-02-16
520101260017627K984077INSTANT-VIEW PREGNANCY COMBO TESTJHI1999-02-16
520101406189130K984076INSTANT-VIEW PREGNANCY URINE TESTJHI1999-02-16
520101646367357K983386BIOSTREP A-DIRECT STREP A ANTIGEN TESTGTY1998-11-25
1097131901892295K982365ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMATDXC1999-04-08
1097131227965902K982276BAHO AUTOCLAVABLE LAPAROSCOPEHET1999-02-18
1097131180623779K981919BISSINGER CABLES, CAT. NO. 801000XXGEI1998-08-06
1097132071892858K974382ACKERMANN SURGICAL INSTRUMENTSGCJ1998-04-21
520101070919849K961024BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WBKTN1997-02-04
1630091545519296K950532TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHYEAP1995-04-19
1097131204979062K930667REUSABLE LAPAROSCOPIC INSTRUMENTSGCJ1994-05-16
1097131391707528K930666REUSABLE LAPAROSCOPIC INSTRUMENTS W/ ELECTROCAUTERYGEI1994-05-19
520102027948526K930488BESURE PLUS/(MIDSTREAM) ONE STEP PREG HOME TESTLCX1993-04-06
1097131545605118K904142GRASPING FORCEPS/ALIGATOR FORCEPS/NEEDLE HOLDERSHET1990-12-05
402981206026635K900557MODIFIED AEROCHAMBER M.V. AEROSOL HOLDING CHAMBERCCQ1991-04-10
520101737059884K882211URISCREENJXA1988-09-30
1630091972051999K260462RCT800OAS2026-04-09
1630091755743434K251798RCT700OAS2025-11-25
1630091890240034K251109SMARTDentLLZ2025-05-21
147731671358207K250665SKR 3000MQB2025-06-17
1630091826953057K243903RCT600OAS2025-03-12
402981162318603K242667AeroChamber2go Anti-Static Valved Holding ChamberNVP2025-01-15
147731848490445K241319SKR 3000MQB2024-11-21
147731217902471K240281Bone Suppression SoftwareLLZ2024-05-31
1630091947390405K233625RAYDENT SWPNN2024-05-16
1630091756666403K232325RAYSCAN a-ExpertMUH2024-04-18
1630092067407210K232287RAYSCAN a-Expert3DOAS2023-08-31
147731902279592K230906Konicaminolta DI-X1LLZ2023-04-25
1630091868571461K230753RCT800OAS2023-04-11
147731724505670K223267SKR 3000MQB2022-11-17
520101852560504K223162Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COTLDJ2023-03-17
402981253762079K220145Monaghan medical filtered mouthpiece kitCAF2023-08-24
147731419508204K213908SKR 3000MQB2022-01-31
1630091476804983K213226RCT700OAS2021-11-29
147731117131008K212685KONICAMINOLTA DI-X1LLZ2021-09-13
147731042977524K210619SKR 3000MQB2021-08-24
402981440605148K203400Corrugated tube with mouthpiece accessoryCAF2021-06-14
1630091014435312K192737RCT800OAS2019-10-22
147731032109945K191645SKR 4000MQB2019-08-16
1526871573485478K191525KinematX Total Wrist Arthroplasty SystemJWJ2020-03-04
1630092009159184K190812RAYSCAN a-Expert3DOAS2019-04-24
1526871726420023K183199TRIO HandpieceGEX2019-05-02
402982028225959K183108Combined Aerobika OPEP and VersaPAP deviceBWF2019-08-16
1630091099303612K182805RCT800OAS2018-12-14
520101899728160K182701Wondfo T-Cup Multi-Drug Urine Test CupNFT2018-12-03
147731848599564K182688SKR 3000MQB2018-12-18
1630091386442948K182614RCT700OAS2018-10-16
147732068907025K182431Konicaminolta DI-X1LLZ2018-11-26
402981147554559K181649AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)NVP2019-01-11
402981722942229K173918VersaPAP Positive Airway Pressure (PAP) DeviceBWF2018-08-17
402981206552055K173825MC 300R* NebulizerCAF2018-05-02
402981430041657K173367MC 300* NebulizerCAF2018-02-28
520101924767199K173303INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)DKZ2018-02-23
147731195564325K172793SKR 3000MQB2017-10-12
147731423374187K171716SKR 3000MQB2017-08-25
520101632893947K163704Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardJXM2017-08-02
1097131951544498K163615Snowden-Pencer MicroLap 3mm Laparoscopic InstrumentsGEI2017-05-04
147731278154475K162504SKR 3000MQB2016-10-03
1630091730957474K160788RIOScan (RPS500)MUH2016-04-15
520101089478509K153597Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardJXM2016-05-23
147731928904768K151465AeroDR SYSTEM 2MQB2015-06-29
402981818528629K150173Aerobika OPEP Devive with ManometerBWF2015-10-15
1630091301120104K143000RIS500MQB2015-01-23
1630091939839026K142058RAYSCAN A-EXPERTMUH2015-04-22
147731357418519K141271AERODR SYSTEM 2MQB2014-09-26
402981125768269K140919RESPICONNECT ADAPTERCAF2014-08-15
520101630106993K133968WONDFO MULTI-DRUG URINE TEST CUP, PANELDKZ2014-02-25
520101804374474K133343WONDFO RAPID STREP A TESTGTY2014-01-31
402981306828032K131881OMBRA TABLE TOP COMPRESSORBTI2013-10-24
520101217512397K131645INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE)DKZ2013-10-07
147731101776524K130936AERODR SYSTEM WITH P-31MQB2013-08-22
855521106611977K130554REDSENSE ALARM SYSTEMODX2013-11-22
520101391813133K130295LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM.NBW2013-06-21
520101881540765K123703HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE)LCX2013-04-10
402981899085433K123614SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS)CAF2013-03-11
402981328509564K123400AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICEBWF2013-05-16
1097131978834503K123077VASCULAR CLAMPSDXC2013-05-14
147731037671963K120752AERODR STITCHING SYSTEMKPR2012-06-08
147731472333601K120477AEROSYNC FOR AERODR SYSTEMMQB2012-04-09
147732015033834K120131REGIUS SIGMA2MQB2012-02-10
147731585556569K113248AERODR SYSTEM WITH P-21KPR2012-01-17
402981446056654K112010AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC)NVP2012-07-11
520102028074254K111999HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINALJIO2012-04-17
147731644269549K110717KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEMMUE2011-12-23
520101506984084K110309FOB ONE STEP RAPID TESTKHE2011-09-14
402981712314580K110136RESPICHAMBER VALVED HOLDING CHAMBERNVP2011-04-18
147731601633909K103703REGUIS SIGMAMQB2011-06-02
855521801607580K103242REDSENSE-ALARM UNIT AND SENSORODX2011-02-10
1097131213396476K102921ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIESGEI2011-12-20
147731401301810K102349AERODR SYSTEMKPR2010-11-24
520101813593032K093879MISSION SALIVA ALCOHOL TEST STRIPDIC2010-08-06
520101298470778K093143MISSION BREATH ALCOHOL DETECTORDJZ2010-01-28
855522006543067K092955REDSENSE-HOME USEODX2010-05-10
147731478969647K092717DIRECT DIGITIZER, REGIUS MODEL 210MQB2009-10-30
520101706887875K091472URITEST 50 AND URITEST 500 URINE ANALYZERKQO2010-04-27
520101317028589K090405LIPIDPRO SYSTEMNBW2009-12-01
402981291514569K090065AEROCHAMBER MINI VENTILATION CHAMBERCAF2009-04-09
520101045160797K082898AMEDICA DRUG SCREEN TEST CUPNGL2008-12-19
147731327191938K081637LASER IMAGER DRYPRO MODEL 873LMC2008-07-01
402981260971437K080926AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZERCAF2008-08-12
520101311539127K073431FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME TKHE2008-01-14
1526871635175774K073409OMNIGUIDE STERILE WAVEGUIDE ADAPTER SYSTEMGEX2007-12-14
520101466266188K071489HOMECHECK MULTIPLE DRUG CUP TESTDKZ2008-03-28
147731960339300K071181DIRECT DIGITIZER, REGIUS MODEL 110MQB2007-05-30
855522062362171K071013REDSENSEODX2007-10-18
402981112489800K070674AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLOW INDICATORNVP2007-04-11
1630091994472540K070464ONDEMAND3DLLZ2007-03-16
520101621232191K063693FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TESTKHE2007-05-11
520101114094567K063545MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINEDJG2007-05-07
1407182032647137K062218JAN MAO WHEELCHAIR, MODELS JMC612-FL318EPP AND JMC612-FL418EPPIOR2006-08-16
147731704863824K061999DRY LASER IMAGER, DRYPRO MODEL 832LMC2006-08-15
520101804917593K061742URYXXON RELAX URINE ANALYZERJIL2006-09-06
520101583233920K061419TECO MICROALBUMIN 2-1 COMBO STRIPSJIR2007-01-26
520101456517502K060466ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICEDJG2006-04-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MQB192025-06-17
CAF122023-08-24
OAS102026-04-09
NVP82025-01-15
LLZ72025-05-21
DKZ72018-02-23
GEI72017-05-04
DJG52007-05-07
LDJ42023-03-17
BWF42019-08-16
ODX42013-11-22
MUH32024-04-18
JXM32017-08-02
GTY32014-01-31
KPR32012-06-08
KHE32011-09-14
IOR32006-08-16
GCJ32006-07-19
JHI31999-02-16
GEX22019-05-02
NBW22013-06-21
DXC22013-05-14
LCX22013-04-10
LMC22008-07-01
JIL22006-09-06
LYR22006-05-01
DQA22004-09-14
LAF22002-10-28
HET21999-02-18
PNN12024-05-16
JWJ12020-03-04
NFT12018-12-03
BTI12013-10-24
JIO12012-04-17
MUE12011-12-23
DIC12010-08-06
KQO12010-04-27
DJZ12010-01-28
NGL12008-12-19
JIR12007-01-26

NDC#

Spravato

Janssen Pharmaceuticals Inc.

Esketamine Hydrochloride

ELMIRON

Janssen Pharmaceuticals, Inc.

PENTOSAN POLYSULFATE SODIUM

INVOKANA

Janssen Pharmaceuticals, Inc.

canagliflozin

INVOKANA

Janssen Pharmaceuticals, Inc.

canagliflozin

SPORANOX

Janssen Pharmaceuticals, Inc.

ITRACONAZOLE

RISPERDAL

Janssen Pharmaceuticals, Inc.

risperidone

RISPERDAL

Janssen Pharmaceuticals, Inc.

risperidone

RISPERDAL

Janssen Pharmaceuticals, Inc.

risperidone

RISPERDAL

Janssen Pharmaceuticals, Inc.

risperidone

RISPERDAL

Janssen Pharmaceuticals, Inc.

risperidone

RISPERDAL

Janssen Pharmaceuticals, Inc.

risperidone

INVOKAMET

Janssen Pharmaceuticals, Inc.

canagliflozin and metformin hydrochloride

INVOKAMET

Janssen Pharmaceuticals, Inc.

canagliflozin and metformin hydrochloride

INVOKAMET

Janssen Pharmaceuticals, Inc.

canagliflozin and metformin hydrochloride

INVOKAMET

Janssen Pharmaceuticals, Inc.

canagliflozin and metformin hydrochloride

INVEGA

Janssen Pharmaceuticals, Inc.

paliperidone

INVEGA

Janssen Pharmaceuticals, Inc.

paliperidone

INVEGA

Janssen Pharmaceuticals, Inc.

paliperidone

INVEGA

Janssen Pharmaceuticals, Inc.

paliperidone

Xarelto

Janssen Pharmaceuticals, Inc.

rivaroxaban

XARELTO

Janssen Pharmaceuticals, Inc.

rivaroxaban

Xarelto

Janssen Pharmaceuticals, Inc.

rivaroxaban

Xarelto

Janssen Pharmaceuticals, Inc.

rivaroxaban

Xarelto

Janssen Pharmaceuticals, Inc.

rivaroxaban

133 records. Showing 1-40. Next

PMA#

PMN#

CRYOBAG

1994-03-02

JANUS BIOMEDICAL, INC.

Applications#

213498

JANSSEN PHARMACEUTICALS INC

98 records. Showing 1-40. Next