FDA.reportPublic FDA data

AND

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10648583008397795ANDERSEN SCIENTIFIC, INC.1N2026-01-011001 Aviation Parkway Suite 600 Morrisville NC US 27560
12207991220799ANDOVER HEALTHCARE, INC.1N2026-01-019 Fanaras Dr SALISBURY MA US 01952
14173671421377AndersonBrecon Inc.1Y2026-01-014545 Assembly Dr ROCKFORD IL US 61109
14508191450819ANDERSONBRECON INC.1N2026-01-011129 18th Ave ROCKFORD IL US 61104
20273442027344ANDWIN SCIENTIFIC1Y2026-01-01167 W. Cochran St. Simi Valley CA US 93065
96123523002808636Anderjeet Gulati1N2026-01-01175 Pineview Dr. Amherst NY US 14228
30016631883001663188ANDI PRESSURE SOLUTIONS INC.1Y2026-01-0174 Woodcleft Avenue Freeport NY US 11520
30034892213003489221Andrea Berti1N2026-01-01610 West 52nd Street New York NY US 10019
30037416763003741676ANDON HEALTH CO., LTD1N2026-01-01No. 3 Jin Ping Street,Ya An Road, NANKAI DISTRICT TIANJIN CN 300190
30041221353004122135Andpak, Inc.1N2026-01-01400 Jarvis Dr. Morgan Hill CA US 95037
30043622353004362235Anderjeet Gulati1N2026-01-01175 Pineview Dr. Amherst NY US 14228
30045301843004530184ANDERSEN CALEDONIA LTD1N2026-01-01Caledonian House, Phoenix Crescent Strathclyde Business Park Bellshill Scotland GB ML4 3NJ
30046347103004634710Andersen Sterilizers, Inc.1N2026-01-013154 Caroline Dr Haw River NC US 27258
30076088643007608864Andrew Farhat1N2026-01-013333 Piedmont Road, Suite 1800 Atlanta GA US 30305
30076115543007611554Andrea Roether1N2026-01-012250 West Southbranch Blvd Oak Creek WI US 53154
30081150013008115001Anderson Zhao1N2026-01-011433 Highway 34 Suite A1 Wall Township, NJ USA Wall Township NJ US 07727
30094962243009496224Anderjeet Gulati1N2026-01-01175 Pineview Dr. Amherst NY US 14228
30101880093010188009Andy Page1N2026-01-0119 Old Kings Hwy S Ste 200 Darien CT US 06820
30104352823010435282Andrew Farhat1N2026-01-013333 Piedmont Rd NE ATL GA US 30305
30117527403011752740Andrea Nicolaisen1N2026-01-0126 Whipple St Nashua NH US 03060
30121840773012184077Andy Smith1N2026-01-018825 53 AVE ELMHURST,NY Elmhurst NY US 11373
30125230633012523063Andrew Hewes1N2026-01-0113465 Midway Rd Ste 310 Dallas TX US 75244
30135445913013544591Andy Kim1N2026-01-011 Columbia Ste 130 Aliso Viejo CA US 92656
30142046313014204631Andy Opliger1N2026-01-012235 Pennsylvania St Fort Wayne IN US 46803
30142336003014233600Andy Smith1N2026-01-018825 53 AVE Elmhurst NY US 11373

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
91151004290114K993783TETRIC FLOWEBF1999-12-13
1949451004290114K993783TETRIC FLOWEBF1999-12-13
1528811045939118K990910MTP HAMOU ENDOMAT DISPOSABLE TUBING SETSHIH1999-06-03
1528811021340258K990909MTP UROPUMP DISPOSABLE TUBING SETLJH1999-06-09
91152063636119K990817IPS D.SIGN PORCELAINEIH1999-04-06
1949452063636119K990817IPS D.SIGN PORCELAINEIH1999-04-06
52111556030078K983428SAFETEX CERVICAL SCRAPER (PLASTIC)HHT1998-11-16
91151647334978K982616IPS EMPRESS 2EIH1998-09-08
1949451647334978K982616IPS EMPRESS 2EIH1998-09-08
91151336848954K980986PROCADEIH1998-05-11
1949451336848954K980986PROCADEIH1998-05-11
91151386082386K974577COMPOGLASS FLOWEBF1998-01-30
1949451386082386K974577COMPOGLASS FLOWEBF1998-01-30
91151912933968K972827IPS EMPRESS COSMO INGOTEIH1997-09-17
1949451912933968K972827IPS EMPRESS COSMO INGOTEIH1997-09-17
1528811061501127K972267HELICA TCGEI1999-09-14
91151139055077K972239ELITE H-D VINYL POLYSILOXANE IMPRESSION MATERIALS .PUTTY SOFT/NORMAL SETTING /PUTTY SOFT/FAST SETTINGELW1997-08-01
1949451139055077K972239ELITE H-D VINYL POLYSILOXANE IMPRESSION MATERIALS .PUTTY SOFT/NORMAL SETTING /PUTTY SOFT/FAST SETTINGELW1997-08-01
91152038004893K972027ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,)ELW1997-07-16
1949452038004893K972027ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,)ELW1997-07-16
91151592926073K971513COMPOGLASS FEBF1997-06-03
1949451592926073K971513COMPOGLASS FEBF1997-06-03
91151006332941K971372VARIOLINK IIEBF1997-05-29
1949451006332941K971372VARIOLINK IIEBF1997-05-29
91151382782870K964285TETRIC CERAMEBF1997-01-22
1949451382782870K964285TETRIC CERAMEBF1997-01-22
91151899672749K962456SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETHELM1996-08-06
1949451899672749K962456SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETHELM1996-08-06
91151861202076K946032FLUOR PROTECTORLBH1995-03-07
1949451861202076K946032FLUOR PROTECTORLBH1995-03-07
91151157916323K934978FERMIT N LIGHT-CURING TEMPORARY FILLING MATERIALEBG1993-12-10
1949451157916323K934978FERMIT N LIGHT-CURING TEMPORARY FILLING MATERIALEBG1993-12-10
91151699999694K934611STO2PEBF1993-11-17
1949451699999694K934611STO2PEBF1993-11-17
91151857157085K932078HELIOSEAL FEBC1993-09-15
1949451857157085K932078HELIOSEAL FEBC1993-09-15
91151724643911K931502VIVAGLASS LINEREJK1993-07-22
1949451724643911K931502VIVAGLASS LINEREJK1993-07-22
52111769080062K930955CERVEX-BRUSHHHT1994-05-24
91151620758919K930835VIVOPERL-PE, VIVAPERL-PE ORTHOTYP/ORTHOTYP AELL1994-07-22
1949451620758919K930835VIVOPERL-PE, VIVAPERL-PE ORTHOTYP/ORTHOTYP AELL1994-07-22
91152044636105K930128SR SPECTRASIT, SR CHROMASITEBF1993-10-07
1949452044636105K930128SR SPECTRASIT, SR CHROMASITEBF1993-10-07
52111933887955K924908CELL COLLECTING BRUSHHHT1993-04-13
91151761065858K922569TETRIC LIGHT-CURING COMPOSITEEBF1992-07-15
1949451761065858K922569TETRIC LIGHT-CURING COMPOSITEEBF1992-07-15
91151361976648K915377SR-IVOCAP PLUSEBI1992-01-31
1949451361976648K915377SR-IVOCAP PLUSEBI1992-01-31
91151753560191K913655PROBASE HOT AND PROBASE COLDEBI1991-10-17
1949451753560191K913655PROBASE HOT AND PROBASE COLDEBI1991-10-17
91151360059025K913372IPS EMPRESSEIH1991-10-25
1949451360059025K913372IPS EMPRESSEIH1991-10-25
91151162210385K910069SR-ISOSIT SPECTRA LINK SYSTEMKLE1992-03-02
1949451162210385K910069SR-ISOSIT SPECTRA LINK SYSTEMKLE1992-03-02
91151929184343K901918HELIOTINTEBF1990-06-26
1949451929184343K901918HELIOTINTEBF1990-06-26
91151141297569K901913SYNTAC (DENTIN BONDING AGENT)KLE1990-06-26
1949451141297569K901913SYNTAC (DENTIN BONDING AGENT)KLE1990-06-26
91151960719964K901261PV-CERAMIC, CERAMINIQUEEIH1990-06-26
1949451960719964K901261PV-CERAMIC, CERAMINIQUEEIH1990-06-26
91151479066150K896530FERMIT TEMPORARY MATERIALEBF1990-05-07
1949451479066150K896530FERMIT TEMPORARY MATERIALEBF1990-05-07
91151265016820K896132ENAMEL PREP ENAMEL ETCHANT (EMAIL-PREPARATOR GS)EBF1990-01-10
1949451265016820K896132ENAMEL PREP ENAMEL ETCHANT (EMAIL-PREPARATOR GS)EBF1990-01-10
91151264409484K896130SR-IVOCAPEBI1990-04-16
1949451264409484K896130SR-IVOCAPEBI1990-04-16
91152073498670K893794APEXIT ROOT CANAL SEALERKIF1989-11-29
1949452073498670K893794APEXIT ROOT CANAL SEALERKIF1989-11-29
52111296324152K890283CYTEX ONE AND CYTEX TWOHHT1989-03-16
91151224614084K884588HELIOMOLAR(R) DENTAL RESTORATIVEEBF1989-01-27
1949451224614084K884588HELIOMOLAR(R) DENTAL RESTORATIVEEBF1989-01-27
91151930422840K864707SR-VIVODENT ANTERIOR & SR-ORTHOTYP POSTERIOR TEETHELM1987-02-10
1949451930422840K864707SR-VIVODENT ANTERIOR & SR-ORTHOTYP POSTERIOR TEETHELM1987-02-10
91152030121463K863421SR-IVOLEN TRAY MATERIALEBH1986-11-03
1949452030121463K863421SR-IVOLEN TRAY MATERIALEBH1986-11-03
91121146690623K844349SR VIVODENT PE ANTERIOR TEETH & SR ORTHOTYP RE POSELM1984-12-03
91151146690623K844349SR VIVODENT PE ANTERIOR TEETH & SR ORTHOTYP RE POSELM1984-12-03
1949451146690623K844349SR VIVODENT PE ANTERIOR TEETH & SR ORTHOTYP RE POSELM1984-12-03
91151798035236K823409HELIOSIT-ORTHODONTICDYH1983-01-21
1949451798035236K823409HELIOSIT-ORTHODONTICDYH1983-01-21
1949451394105118K820389A DENTAL AMALGAM ALLOY (UNNAMEDEJJ1982-03-11
91151115191069K813015HELIOSEALEBC1981-12-02
1949451115191069K813015HELIOSEALEBC1981-12-02
1949451309194306K810972THE GNATHOMETER-MKZO1981-05-05
91151436236381K810970ISOSIT TEETHELM1981-05-05
1949451436236381K810970ISOSIT TEETHELM1981-05-05
91151415210633K802681HELIOBONDKLE1980-11-24
1949451415210633K802681HELIOBONDKLE1980-11-24
1949452015891047K801690VALIANTEJJ1980-08-13
2111851217074175K260037implantcast Packaging System UpdateLZO2026-03-30
91151567340002K253953IPS e.max ZirconiaEIH2026-03-10
1949451567340002K253953IPS e.max ZirconiaEIH2026-03-10
2111851412638475K252451EPORE® XO cup systemOQI2026-04-24
91151109198027K252450Adhese 2KLE2026-03-05
1949451109198027K252450Adhese 2KLE2026-03-05
2111851793679388K252401implaFit® short stemsLZO2026-03-12
615651472109726K251113iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless Blood Pressure Monitor(BP-300CV);iHealth Compare S Wireless Blood Pressure Monitor(BP-300V);iHealth Wireless Blood Pressure Monitor(BPX1);iHealth Blood Pressure Monitor(KD-595);iHealth Track Pro Connected Blood Pressure Monitor(KN-550LT);Semi Automatic Blood Pressure Monitor(KD-388N);Arm Blood Pressure Monitor(KD-553);Arm Blood Pressure Monitor(KD-557BR);Arm Blood Pressure Monitor(KD-558);Arm Blood PrDXN2025-08-04
2111851316883727K241944AGILON® XO Shoulder Replacement SystemKWT2025-03-10
615651185217173K241394iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripLCX2024-12-20
2111851847905729K240834EcoFit® short stem cementless cpTiLZO2024-06-03
2111851342131162K240391MUTARS® femoral stem cemented 160 mm and 200 mmLZO2024-10-24
2111851863000819K234044ACS® LD FB Knee SystemJWH2024-09-06
615651929357545K234041Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5920VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5920BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5923TS)DXN2024-04-22
1690631956981493K234029CEFALY Connected - OTC, CEFALY Connected - RxPCC2024-07-18
91151076388981K233995Ivotion Base PrintEBI2024-02-23
1949451076388981K233995Ivotion Base PrintEBI2024-02-23
2111851220930586K232371Actinia® hip stemsLZO2023-10-19
2111851052405957K231657AGILON® XO Shoulder Replacement SystemKWT2024-02-16
2111851481088975K223103BethaLoc® stem cementless HALZO2023-06-20
1887321799607575K222991Air Compression Leg Massager (model: EMK-701)IRP2023-03-15
615651075810766K222867AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)NUH2022-12-21
2111851473046452K222482AGILON XO Shoulder SystemKWT2022-09-28
615651390195900K222034RightLance Blood Lancing SystemQRL2022-09-07
91151009991563K213482TIA Tip, Cariosity, Transillumination Accessory TipNTK2022-04-29
1949451009991563K213482TIA Tip, Cariosity, Transillumination Accessory TipNTK2022-04-29
1930241439595263K213296Anprolene SteriTest RRBIFRC2022-04-12
615651964075302K212598iHealth infrared Ear thermometer PT5FLL2022-01-28
1690631787783569K212071Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - RxPCC2022-12-13
91151511337333K211916IPS e.max OneEIH2021-08-20
1949451511337333K211916IPS e.max OneEIH2021-08-20

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EBF512019-03-14
DXN372025-08-04
EIH342026-03-10
ELM192014-01-14
KLE172026-03-05
NHA172020-11-16
EMA132018-05-08
EBG132016-04-12
EBI122024-02-23
ELW112015-04-03
LZO102026-03-30
LBH102020-02-11
EBZ92019-07-03
PCC72024-07-18
FRG62020-11-12
EBC62019-07-29
GEI62008-01-09
FRC52022-04-12
FLL52022-01-28
JOJ52020-11-12
NBW42019-02-01
EJK42006-04-17
HHT41998-11-16
KWT32025-03-10
FLF32020-11-12
OTO32012-05-17
NTK22022-04-29
DXQ22021-09-23
MEH22020-10-16
DSA22020-06-22
PEM22019-10-08
DQA22018-08-31
OTN22009-08-12
PAH22009-07-14
KNS22009-06-10
GEX22007-03-21
CAH22005-06-29
ELR22004-11-22
ELL21994-07-22
KIF21989-11-29

NDC#

Oxygen

Andy-Oxy Co., Inc.

Oxygen

Air

Andy-Oxy Co., Inc.

Air

PMN#

197 records. Showing 1-40. Next

Applications#

43 records. Showing 1-40. Next