FDA.reportPublic FDA data

WECO

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
Weiguo ZHANG5N2026-01-013846 W Naughton Ave Belmont CA US 94002
10340841034084WestBridge Vocational, Inc.1N2026-01-01140 Little Savannah Rd SYLVA NC US 28779
13157561315756Weco Manufacturing Group-Henrietta1N2026-01-01275 COMMERCE DR Rochester NY US 14623
13164631316463WELCH ALLYN, INC.1Y2026-01-014341 STATE STREET RD. Skaneateles Falls NY US 13153
14503861416404WEIMAN PRODUCTS, LLC1N2026-01-01755 Tri State Pkwy GURNEE IL US 60031
15268091526809Western Enterprises, Inc.1Y2026-01-01875 Bassett Rd Westlake OH US 44145
16467471000160162WEXLER SURGICAL, INC.1Y2026-01-0111333 Chimney Rock Rd Suite 110-120 HOUSTON TX US 77035
16518973004334060WE PACK LOGISTICS, LLC1N2026-01-012300 13th St Sw PARIS TX US 75460
19103381910338WEEKS & LEO INC.1Y2026-01-012075 NW 92ND CT Clive IA US 50325
20203722020372WESTWOOD LABORATORIES, LLC.1N2026-01-01710 S AYON AVE Azusa CA US 91702
20240222024022WELLS JOHNSON CO.1N2026-01-018000 S Kolb Rd Tucson AZ US 85756
20256482025648West Pharmaceutical Services AZ, Inc.1N2026-01-01640 S Rockford Dr TEMPE AZ US 85288
20288071000374126WESTMED, INC.1N2026-01-015580 S NOGALES HWY TUCSON AZ US 85706
20328613004217756West Pharmaceutical Services Arizona, Inc.1N2026-01-01470 West Vaughn Street Tempe AZ US 85283
20328623001155023West Pharmaceutical Services AZ, Inc.1Y2026-01-0114677 NORTH 74TH ST. SCOTTSDALE AZ US 85260
20855923000207061Wessco International1Y2026-01-0111400 W. Olympic Blvd # 450 LOS ANGELES CA US 90064
20870503003144191WEST COAST TRENDS, INC.1Y2026-01-0117811 Jamestown Ln Huntingtn Bch CA US 92647
20874443003560244WELLELL AMERICA CORP.1Y2026-01-01927 Mariner Street Brea CA US 92821
20943772094377WESTONE LABORATORIES, INC.1N2026-01-012260 Executive Cirle Colorado Springs CO US 80906
22472901000129707Welwaze Medical, Inc.1N2026-01-012800 NW 105 Ave Doral FL US 33172
25294541000121475WEBB MEDICAL1N2026-01-011241 CARPENTER ST. Phila PA US 19147
80102823002808477WEBA MEDIZINTECHNIK GMBH & CO.1N2026-01-01SCHLOSSAECKERWEG 6/1 BALGHEIM Baden-Wurttemberg DE 78582
80306473014611165Westmed de Mexico, S.A de C.V1N2026-01-01CARRETERA INTERNACIONAL SALIDA NORTE No. 1053 MAGDALENA Sonora MX CP 84160
80434393004411059Wellell Inc.1N2026-01-01No. 9, MIN SHENG ST., TU-CHENG NEW TAIPEI CITY TW 236044
80441313004545399WESLEY COE (CAMBRIDGE) LTD1N2026-01-01GAS LANE ELY, CAMBS Cambridgeshire GB CB7 4GH

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
135411580324005P920046FILSHIE CLIP (MARK VI) SYSTEMKNH1996-09-05
809241711539377K991437WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00FRN1999-08-30
120521485003663K990435BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100CAF2000-06-05
270002030099993K974062MEDSCI 3% GLUTARALDEHYDEMED1998-09-02
462702045466716K973238ZEFON ADULT ANESTHESIA BREATHING CIRCUIT WITH FILTER, ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT WITH FILTERCAH1998-03-11
462701686551124K963910HEART NEBULIZER #100609CAF1996-12-16
462701911593394K955047WESTMED CIRCULARIE PEP DEVICESBYE1996-03-27
462701059087308K954271WESTMED CONDESATE COLLECTION TRAPCAW1995-12-28
462701442244043K951484WESTMED BACTERIAL/VIRAL FILTERCAH1995-04-24
3014001672544204K950461WELCH ALLYN OPHTHALMOSCOPEHLI1995-04-04
462701262620169K944941PISTON SYRINGECBT1994-12-05
462702003109212K943600UNIHEARTCAF1994-10-13
462701255930675K940581BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORSBTM1994-05-06
462701669886022K934310BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATORBTM1993-12-14
462701101112500K932709PRECISION MED PRODUCTS LTD HYPERINFLATION SYSTEMBZR1993-07-23
462702051636008K931924MARKSMAN ARTERIAL BLOOD GAS SYRINGEJKA1993-08-03
3014001228489391K930604BALANCED(TM) NYLON BLADDERDXQ1993-04-30
3014001367767271K930023MODEL #12000 BINOCULAR INDERECT OPHTHALMOSCOPEHLI1993-06-21
462701966926330K926055THE MILLER NEBULIZER SYSTEMCAF1993-02-03
462701484065496K925173BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINTLYA1993-01-15
462701764772620K924667AEROSOL CHARGING ADAPTOR (FOR USE W/MININEB ONLY)CAF1993-08-26
462701332241550K923618PEEP VALVEBYE1992-08-03
462701714871738K923596HEART NEBULIZERCAF1992-10-15
462701238672782K922492SPECIALTY PACKAGING PROD BACTERIAL/VIRAL FILTERCAH1992-08-24
462701333149028K920443MININEBCAF1992-07-02
462701313374607K914778NEOLINE(TM)CBT1992-09-16
462701647749127K913163NON REBREATHING VALVECBP1992-02-03
462701414623222K904538MAUNA LOA ENHANCED HEATED BREATHING CIRCUITCAI1991-04-24
3014001186321623K884421PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREATDXQ1989-01-13
462701702960350K881451SIMPLEX UNIVERSAL HEATED TUBING SLEEVEBZE1988-06-10
462701718382401K870173LAVABED SYSTEM & CHAMBER, LAVAPAK TEMP. CONTROLBTT1987-04-03
1951601375616K864899SURGICAL DRAPE PACKKKX1987-01-20
3014001622606206K861516WELCH ALLYN TYMPANOMETERETY1986-06-10
1136031520969250K832989BREAST THERMAL ACTIVITY INDICATORKYA1984-01-17
809242036810033K832274ASPIRATORBTA1983-10-20
462701883305025K822786MDM ARTERIAL BLOOD GAS KITCBT1982-10-21
3014001331560134K810227MODEL #53110 DISPOSABLE ANOSCOPEFER1981-02-19
462701330462419K800562DISPOSABLE HAND HELD NEBULIZERCAF1980-03-25
3014001253908500K790610SIGMOIDOSCOPE TIPLESSFAM1979-04-23
3014001121028575K771864WALL TRANSFORMERS 74710 & 74910GCW1977-11-22
3014001162593877K770906ANOSCOPE, OPTIC, FIBERFER1977-06-01
3014002004276712K770768OPHTHALMOSCOPE, MODEL #11100HLI1977-05-06
3014001119984674K770291SIGMOIDOSCOPE, DISPOSABLE, MODEL #53125FAM1977-02-18
3511411941840140K253720uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace EliteIYN2026-05-21
3511411836117341K253716uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus SuperIYN2026-05-15
3014001878909856K251745Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)DXQ2025-12-16
120521563150947K251466VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential ComprJOW2025-10-28
3014001294216103K243598Welch Allyn Connex® 360 (Multiple)2025-07-13
120521589975122K243023WiZARD 520 Full Face MaskBZD2025-05-23
3014001301975121K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)MWI2024-12-20
3014001137950262K223381iExaminer System with Panoptic PlusHKI2023-03-15
3014001881115596K212473Welch Allyn Connex Central StationMWI2022-10-28
120521373774889K193206WiZARD 510 Nasal MaskBZD2020-10-29
588651639807561K191666Unscented W long plastic and cardboard applicator tamponsHEB2019-12-20
3014001425281837K191013Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry optionBZG2019-09-10
120521499479054K182394WiZARD 310/320 Series CPAP MaskBZD2019-05-17
3014001954100216K181720Epiphany Cardio Server MobileDQK2018-07-30
3014001444068202K181016Welch Allyn RetinaVue Network REF 901108 PACS Medical Image SystemNFJ2018-07-16
3014001051165059K173765Surveyor Patient MonitorMHX2018-09-04
3014001312470831K171621Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs MonitorMHX2017-06-30
1690751588684645K171191Hexagen DermFRO2017-08-25
3014001239897990K170037Breathe Technologies Life2000™ Ventilation SystemCBK2017-08-11
588651909584169K162746Ontex and other proprietary namesHEB2017-03-03
462701850373865K162343Westmed Gas Sampling Cannula with O2 deliveryCCK2016-12-14
3014001772748781K152944Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing SystemsDPS2016-01-06
3014001187998162K152748Braun Thermoscan PRO 6000 Ear ThermometerFLL2016-03-01
3014001859874371K152626H3+ Holter RecorderMWJ2016-02-26
120522030099830K150111Apex Medical Corp. iCH CPAP with PVA 9S-007XXX SeriesBZD2015-09-15
3014001056118809K142356Connex Spot Monitor,901058 Vital Signs Monitor CoreMWI2014-12-19
3014001729447919K142105ELI 380 ELECTROCARDIOGRAPHDPS2014-09-05
3014001766633364K141582CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTIONDPS2014-07-11
120521466982418K141522APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIESBZD2014-10-06
462701080017238K133057VIBRALUNG ACOUSTICAL PERCUSSORSDT2014-05-23
3014001250747314K132807MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)MWI2014-01-31
588651059258678K132595ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONSHEB2014-04-23
1690751833251519K132329NIVATOPIC PLUSFRO2013-12-20
462701475093026K130091PULMOSALCAF2013-03-13
3014001603225917K122401TANGO M2 BLOOD PRESSURE MONITORDXN2012-11-02
3014001003118657K122073ELI 280 ELECTROCARDIOGRAPHDPS2012-08-02
3014001466887703K122058FLEXIPORT ECOCUFFDXQ2012-11-05
120521444087757K121642WIZARD 230 NASAL PILOW MASKBZD2013-06-06
3014002018334217K121405PANOPTICHKI2012-12-20
462701697903705K121382WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)]CAH2012-12-06
3014001034876441K120865RSCRIBE ELECTROCARDIOGRAPHDPS2012-07-19
120521526969712K120035APEX MEDICAL ICH CPAP SERIES (9S-007XXX)BZD2012-05-16
588652049784421K112635U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONSHEB2011-10-07
120521357401630K112079APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720BZD2012-12-06
462701405325554K110713WATERPAP VALVEBYE2011-09-12
475461909907124K110148WEXLER VASCULAR CLAMP SERIESDXC2011-04-19
475461205702453K110121WEXLER ENDOSCOPE ACCESSORIESGCJ2011-05-10
120521773926481K103535VACPLUS SUCTION UNITJCX2011-02-24
120521089123585K103174APEX MEDICAL WIZARD SERIES CPAP MASKBZD2011-05-06
3014001126576437K101680WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIESDXN2010-07-09
3014001504386405K101403ELI 250 ELECTROCARDIOGRAPHDPS2010-07-02
3014001283240081K101115ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150DPS2010-06-18
3014002024921149K100127ELI 230 ELECTROCARDIOGRAPHDPS2010-04-16
462701750636158K091862NESSI SPACERNVO2009-11-20
588651222799054K091749U BY KOTEX CLICK* UNSCENTED TAMPONS, MODEL ABSORBENCY: REGULAR, SUPER AND SUPER PLUSHEB2009-12-23
120521254891262K083656APEX MEDICAL XT AUTO CPAP 9S-005200BZD2009-04-22
3014001139128819K082478WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62BZG2009-03-09
3014001997493657K080189TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX ; VINYL,MODEL 99XXXDXQ2008-08-15
462701754119819K072220PEDI CO2 EASYCCK2007-08-23
120521363552864K070990APEX MEDICAL MOBINEB, 9R-027 SERIESCAF2007-05-18
120521452631921K070609APEX MEDICAL XT1 CPAP, MODEL 9S-005BZD2007-05-04
462701471657802K070128CO2 EASYCCK2007-02-15
3014001750073315K070060WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE)DXQ2007-12-18
120521901607378K063268CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235BZD2007-02-23
120521310542459K062664HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004BTT2006-12-06
3014001537674016K053381WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWAREDQA2006-06-15
3014001770665028K053078ERGOSELECT 100 K/P, ERGOSELECT 200 K/PISD2006-04-27
3014001640858346K052883CARDIOSERVERDQK2005-11-01
3014001369461783K051730MATRIX HOLTER SYSTEM, MODEL M12MLO2005-09-26
3014001846668565K050896H12+ HOLTER RECORDERDSH2005-08-24
1952010460637K050508HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPESKKX2005-04-27
120521608805463K050104APEX MEDICAL MININEB & MINIPLUSCAF2005-02-16
462701835581130K040991AMBU DISPOSABLE PRESSURE MANOMETERCAP2004-07-22

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
BZD122025-05-23
CAF112013-03-13
DPS82016-01-06
DXQ72025-12-16
HEB52019-12-20
MWI42024-12-20
CAH42012-12-06
HLI42001-01-25
CBT41994-12-05
CCK32016-12-14
DXN32012-11-02
BYE32011-09-12
BTT32006-12-06
IYN22026-05-21
HKI22023-03-15
BZG22019-09-10
MHX22018-09-04
DQK22018-07-30
FRO22017-08-25
GCJ22011-05-10
DXC22011-04-19
MLO22005-09-26
KKX22005-04-27
BTM21994-05-06
FER21981-02-19
FAM21979-04-23
JOW12025-10-28
NFJ12018-07-16
CBK12017-08-11
FLL12016-03-01
MWJ12016-02-26
SDT12014-05-23
JCX12011-02-24
NVO12009-11-20
DQA12006-06-15
ISD12006-04-27
DSH12005-08-24
CAP12004-07-22
MOD12004-06-03
BTI12003-10-07

NDC#

Oxytocin

West-Ward Pharmaceuticals Corp

Oxytocin

Oxytocin

West-Ward Pharmaceuticals Corp

Oxytocin

Oxify

Weeks & Leo Compnay, INC.

Lidocaine 5%

Oxify

Weeks & Leo Compnay, INC.

Lidocaine 5%

Bite and Itch

Weeks & Leo Co., Inc.

Diphenhydramine Hydrochloride, Pramoxine Hydrochloride

Lice Killing

Weeks & Leo Co., Inc.

Piperonyl butoxide, Pyrethrum extract

Lice Killing

Weeks & Leo Co., Inc.

Piperonyl butoxide, Pyrethrum extract

OXYGEN

Welders Supply Company

OXYGEN

First Degree

Welmedix LLC

Calendula Officinalis, Echinacea Angustifolia, Cantharis Vesicatoria

200 records. Showing 1-40. Next

PMA#

UNISOL

1989-08-30

WESLEY JESSEN CORP.

UNISOL

1989-08-01

WESLEY JESSEN CORP.

UNISOL

1989-06-01

WESLEY JESSEN CORP.

UNISOL

1988-10-18

WESLEY JESSEN CORP.

UNISOL

1988-05-25

WESLEY JESSEN CORP.

UNISOL

1988-03-14

WESLEY JESSEN CORP.

132 records. Showing 1-40. Next

PMN#

200 records. Showing 1-40. Next

Applications#

220266

WELDERS SUPPLY COMPANY OF LOUISVILLE INC

214937

WESTAIR GASES & EQUIPMENT INC

205809

WESTAIR GASES & EQUIPMENT INC

200 records. Showing 1-40. Next