FDA.reportPublic FDA data

WECO

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
Wen Wang5N2026-01-018880 Rio San Diego Dr Ste 800 San Diego CA US 92108
WEIFANG KEEPBETTER HEALTHCARE CO., LTD.5N2026-01-01No. 272, Dongfeng East Street, Kuiwen District, Weifang Shandong CN 261041
Weian Huang5N2026-01-017 Yale Ct Trabuco Canyon CA US 92679
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

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
809241711539377K991437WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00FRN1999-08-30
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
3528091953971743K254286Guided Bone Regeneration SystemDZL2026-08-24
3014001878909856K251745Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)DXQ2025-12-16
3014001294216103K243598Welch Allyn Connex® 360 (Multiple)2025-07-13
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
588651639807561K191666Unscented W long plastic and cardboard applicator tamponsHEB2019-12-20
3014001425281837K191013Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry optionBZG2019-09-10
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
3014001056118809K142356Connex Spot Monitor,901058 Vital Signs Monitor CoreMWI2014-12-19
3014001729447919K142105ELI 380 ELECTROCARDIOGRAPHDPS2014-09-05
3014001766633364K141582CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTIONDPS2014-07-11
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
3014002018334217K121405PANOPTICHKI2012-12-20
462701697903705K121382WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)]CAH2012-12-06
3014001034876441K120865RSCRIBE ELECTROCARDIOGRAPHDPS2012-07-19
588652049784421K112635U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONSHEB2011-10-07
462701405325554K110713WATERPAP VALVEBYE2011-09-12
475461909907124K110148WEXLER VASCULAR CLAMP SERIESDXC2011-04-19
475461205702453K110121WEXLER ENDOSCOPE ACCESSORIESGCJ2011-05-10
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
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
462701471657802K070128CO2 EASYCCK2007-02-15
3014001750073315K070060WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE)DXQ2007-12-18
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
462701835581130K040991AMBU DISPOSABLE PRESSURE MANOMETERCAP2004-07-22
462701014673473K040712AIR SAFETY HEPA, MODEL 3500MOD2004-06-03
462701511327569K031413VIGORMIST COMPRESSOR NEBULIZERBTI2003-10-07
3014001201497234K021756WELCH ALLYN ABPM 6100DXN2002-06-27
3014001090166206K012455WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEMDXQ2001-08-17
3014001049420833K004017H-SCRIBEMLO2001-06-11
3014001092635745K003376WELCH ALLYN 11800 OPTHALMOSCOPEHLI2001-01-25
475461003296824
475461007259822
475461016657845
475461027199204
475461044089711
475461051293284
723091053473671
475461062954260
723091065831850
723091066247929
475461068712264
723091068736199
723091078947428
809241082554177
475461084241236

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DPS82016-01-06
CAF82013-03-13
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
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
DZL12026-08-24
NFJ12018-07-16
CBK12017-08-11
FLL12016-03-01
MWJ12016-02-26
SDT12014-05-23
NVO12009-11-20
DQA12006-06-15
ISD12006-04-27
DSH12005-08-24
CAP12004-07-22
MOD12004-06-03
BTI12003-10-07
FRN11999-08-30
MED11998-09-02
CAW11995-12-28
JKA11993-08-03

NDC#

200 records. Showing 1-40. Next

PMA#

132 records. Showing 1-40. Next

PMN#

200 records. Showing 1-40. Next

Applications#

200 records. Showing 1-40. Next