FDA.reportPublic FDA data

WELCH ALLYN, INC.

Matched from indexed company URL: WELCH ALLYN

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
13164631316463WELCH ALLYN, INC.1Y2026-01-014341 STATE STREET RD. Skaneateles Falls NY US 13153
30060877893006087789WELCH ALLYN DE MEXICO, S. DE R.L. DE C.V.1N2026-01-01CALLE EMILIO FLORES 2471-A and 2469-C COL. CANON DEL PADRE TIJUANA Baja California MX CO 22203
13164631316463WELCH ALLYN, INC.1Y2020-04-254341 STATE STREET RD. Skaneateles Falls NY US 13153
21834612183461Welch Allyn, Inc.1N2020-04-257865 NORTH 86TH ST. MILWAUKEE WI US 53224
30060877893006087789WELCH ALLYN DE MEXICO, S. DE R.L. DE C.V.1N2020-04-25CALLE EMILIO FLORES 2471-A, COL. CANON DEL PADRE TIJUANA Baja California MX CO 22203

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
00732094210071Welch Allyn, Inc. - Welch Allyn Connex Spot Monitor with SureBP Non-invasive Blood Pressure, Masimo SpO2, SureTemp Plus Thermometer+1(315)685-2834gdsn_support@MyHillRom.onmicrosoft.com
00732094210118Welch Allyn, Inc. - Welch Allyn Connex Spot Monitor with SureBP Non-invasive Blood Pressure, Covidien SpO2, SureTemp Plus Thermometer+1(315)685-2834gdsn_support@MyHillRom.onmicrosoft.com
00732094210248Welch Allyn, Inc. - Welch Allyn Connex Spot Monitor with SureBP Non-invasive Blood Pressure, SureTemp Plus Thermometer+1(315)685-2834gdsn_support@MyHillRom.onmicrosoft.com
00732094210293Welch Allyn, Inc. - Welch Allyn Connex Spot Monitor with SureBP Non-invasive Blood Pressure, Braun Thermoscan PRO 6000 Ear Thermometer+1(315)685-2834gdsn_support@MyHillRom.onmicrosoft.com
00732094210408Welch Allyn, Inc. - Welch Allyn Connex Spot Monitor with SureBP Non-invasive Blood Pressure, Nonin SpO2, SureTemp Plus Thermometer+1(315)685-2834gdsn_support@MyHillRom.onmicrosoft.com
00732094210460Welch Allyn, Inc. - Welch Allyn Connex Spot Monitor with SureBP Non-invasive Blood Pressure, Nonin SpO2, Braun ThermoScan PRO 6000 Ear Thermometer+1(315)685-2834gdsn_support@MyHillRom.onmicrosoft.com
00732094210705Welch Allyn, Inc. - Welch Allyn Connex Spot Monitor with SureBP Non-invasive Blood Pressure, Nonin SpO2+1(315)685-2834gdsn_support@MyHillRom.onmicrosoft.com
00732094210712Welch Allyn, Inc. - Welch Allyn Connex Spot Monitor with SureBP Non-invasive Blood Pressure, Nonin SpO2, Braun ThermoScanPRO 6000 Ear Thermometer+1(315)685-2834gdsn_support@MyHillRom.onmicrosoft.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2256781068985771K974149AMBULATORY X-12 TELEMETRY MODULEDRG1998-01-08
1884311532056017K972121ACUITY CENTRAL STATIONMLD1997-11-07
1884311068960494K955635VIDEO COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM STANDHEX1996-05-07
1884311105285183K951246PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONSFLS1996-02-02
3014001672544204K950461WELCH ALLYN OPHTHALMOSCOPEHLI1995-04-04
1884311706262343K950461WELCH ALLYN OPHTHALMOSCOPEHLI1995-04-04
2256781213145082K945985PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400DQK1995-07-03
1884311107765938K945071PROPAQ 200 MONITORDRT1995-05-10
1883651223490972K940493HAND ANEROID SPHYGMOMANOMETERDXQ1994-07-01
1884311223490972K940493HAND ANEROID SPHYGMOMANOMETERDXQ1994-07-01
1884311302589906K9356094002 INFANT SCALE FOR INCUBATORS AND WARMERSFMT1994-07-01
1883651072087295K930604BALANCED(TM) NYLON BLADDERDXQ1993-04-30
1884311072087295K930604BALANCED(TM) NYLON BLADDERDXQ1993-04-30
3014001228489391K930604BALANCED(TM) NYLON BLADDERDXQ1993-04-30
2256781393277770K930558MORTARA INSTRUMENT, INC. E-SCRIBEDPS1993-04-27
1884311119950133K930023MODEL #12000 BINOCULAR INDERECT OPHTHALMOSCOPEHLI1993-06-21
3014001367767271K930023MODEL #12000 BINOCULAR INDERECT OPHTHALMOSCOPEHLI1993-06-21
1884311405614014K902730SPO2 OPTIONDQA1990-10-22
3014001186321623K884421PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREATDXQ1989-01-13
1883651977784486K884421PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREATDXQ1989-01-13
1884311977784486K884421PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREATDXQ1989-01-13
1884311350137177K861516WELCH ALLYN TYMPANOMETERETY1986-06-10
3014001622606206K861516WELCH ALLYN TYMPANOMETERETY1986-06-10
3014001331560134K810227MODEL #53110 DISPOSABLE ANOSCOPEFER1981-02-19
1884311981870125K810227MODEL #53110 DISPOSABLE ANOSCOPEFER1981-02-19
3014001253908500K790610SIGMOIDOSCOPE TIPLESSFAM1979-04-23
1884311759727605K790610SIGMOIDOSCOPE TIPLESSFAM1979-04-23
2256781091565076K781430PREGELLED DISPOSABLE E.K.G. ELECTRODEDRX1978-10-31
1884311041603510K77190071110 DESK CHARGERHLS1977-11-09
3014001121028575K771864WALL TRANSFORMERS 74710 & 74910GCW1977-11-22
1884311961456979K771864WALL TRANSFORMERS 74710 & 74910GCW1977-11-22
3014001162593877K770906ANOSCOPE, OPTIC, FIBERFER1977-06-01
1884311596846834K770906ANOSCOPE, OPTIC, FIBERFER1977-06-01
1883651750406458K770768OPHTHALMOSCOPE, MODEL #11100HLI1977-05-06
1884311750406458K770768OPHTHALMOSCOPE, MODEL #11100HLI1977-05-06
3014002004276712K770768OPHTHALMOSCOPE, MODEL #11100HLI1977-05-06
3014001119984674K770291SIGMOIDOSCOPE, DISPOSABLE, MODEL #53125FAM1977-02-18
1884311832393054K770291SIGMOIDOSCOPE, DISPOSABLE, MODEL #53125FAM1977-02-18
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
1883651767516204K192143Maximus SystemNHJ2020-02-14
2256781190618994K191013Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry optionBZG2019-09-10
3014001425281837K191013Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry optionBZG2019-09-10
2256781344474049K182297Surveyor S2DRG2019-01-24
1883651034956762K181832Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure DeviceDXN2019-04-09
3014001954100216K181720Epiphany Cardio Server MobileDQK2018-07-30
1884311117479253K181016Welch Allyn RetinaVue Network REF 901108 PACS Medical Image SystemNFJ2018-07-16
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
3014001239897990K170037Breathe Technologies Life2000™ Ventilation SystemCBK2017-08-11
1883651951177096K170037Breathe Technologies Life2000™ Ventilation SystemCBK2017-08-11
3014191113914686K161886Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure DeviceDXN2016-10-14
1883651193765222K161886Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure DeviceDXN2016-10-14
2256781066899702K161465CardioConfirmDQK2016-09-03
2256781916549036K160685Surveyor S4 Mobile MonitorMHX2016-08-04
2256781379621278K152944Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing SystemsDPS2016-01-06
3014001772748781K152944Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing SystemsDPS2016-01-06
3014001187998162K152748Braun Thermoscan PRO 6000 Ear ThermometerFLL2016-03-01
1884312066928816K152748Braun Thermoscan PRO 6000 Ear ThermometerFLL2016-03-01
2256781507404205K152626H3+ Holter RecorderMWJ2016-02-26
3014001859874371K152626H3+ Holter RecorderMWJ2016-02-26
1883651639053740K151689MetaNeb 4 SystemNHJ2016-03-17
3014001056118809K142356Connex Spot Monitor,901058 Vital Signs Monitor CoreMWI2014-12-19
1884311895712976K142356Connex Spot Monitor,901058 Vital Signs Monitor CoreMWI2014-12-19
3014001729447919K142105ELI 380 ELECTROCARDIOGRAPHDPS2014-09-05
2256781988900869K142105ELI 380 ELECTROCARDIOGRAPHDPS2014-09-05
1883651105118268K141943BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEMCBK2015-06-12
2256781125552235K141811MORTARA MONITORING WAVEFORM VIEWERMHX2014-11-19
1884311063307305K141582CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTIONDPS2014-07-11
3014001766633364K141582CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTIONDPS2014-07-11
2256781504075235K133989AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEMDXN2014-11-25
1884311371046597K132808VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITORMWI2013-11-20
1884311106370151K132807MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)MWI2014-01-31
3014001250747314K132807MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)MWI2014-01-31
2256781106582946K131929SURVEYOR CENTRAL STATIONMHX2013-12-03
2256781266034028K123556MORTARA SURVEYOR PATIENT MONITORMHX2013-03-22
3014001603225917K122401TANGO M2 BLOOD PRESSURE MONITORDXN2012-11-02
3014001003118657K122073ELI 280 ELECTROCARDIOGRAPHDPS2012-08-02
2256781521969676K122073ELI 280 ELECTROCARDIOGRAPHDPS2012-08-02
3014001466887703K122058FLEXIPORT ECOCUFFDXQ2012-11-05
1884311546727526K122058FLEXIPORT ECOCUFFDXQ2012-11-05
3014002018334217K121405PANOPTICHKI2012-12-20
1884312044920862K121405PANOPTICHKI2012-12-20
1884311419863126K121013CONNEX VITAL SIGNS MONITOR 6000 SERIESMWI2012-07-26
3014001034876441K120865RSCRIBE ELECTROCARDIOGRAPHDPS2012-07-19
2256781074329346K120865RSCRIBE ELECTROCARDIOGRAPHDPS2012-07-19
1884311243973981K120774ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LTDSI2012-04-10
1884311674840870K120743SPECULUM, VAGINAL, NONMETALHIB2012-03-23
1884311260985352K120343CONNEX WORKSTATIONMWI2012-02-24
1884311899187755K112687CONNEX(R) VITAL SIGNS MONITOR 6000 SERIESMWI2011-11-22
1883651814676448K102525BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)ONZ2010-12-02
2256781366521907K102206ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10DPS2011-02-18
3014001126576437K101680WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIESDXN2010-07-09
1884311615258026K101680WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIESDXN2010-07-09
3014001504386405K101403ELI 250 ELECTROCARDIOGRAPHDPS2010-07-02
2256781782549132K101403ELI 250 ELECTROCARDIOGRAPHDPS2010-07-02
3014001283240081K101115ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150DPS2010-06-18
2256782043594202K101115ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150DPS2010-06-18
1883651148353166K100528BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2SONZ2010-04-23
2256781128605463K100127ELI 230 ELECTROCARDIOGRAPHDPS2010-04-16
3014002024921149K100127ELI 230 ELECTROCARDIOGRAPHDPS2010-04-16
2256781302641842K093339ELI PC ELECTROCARDIOGRAPHDPS2010-02-19
2256781419955413K093211CARECENTER MDDPS2010-06-03
2256781368171417K092663ELI 350 ELECTROCARDIOGRAPHDPS2009-12-14
1883651543397542K082982BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIESONZ2009-07-20
3014001139128819K082478WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62BZG2009-03-09
1884311294330815K082478WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62BZG2009-03-09
2256781898482664K081800T12S TELEMETRY TRANSMITTERDQA2008-09-24
1884311504308200K081160AVITA RADAR THERMO IR THERMOMETER, NT1 SERIESFLL2008-06-24
2256781543864340K080605SURE-LOCK ELECTRODE CLIP, MODEL CL-34, CL-A60, CL-HW, CL-TLDSA2008-05-05
1883651685579337K080189TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX ; VINYL,MODEL 99XXXDXQ2008-08-15
1884311685579337K080189TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX ; VINYL,MODEL 99XXXDXQ2008-08-15
3014001997493657K080189TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX ; VINYL,MODEL 99XXXDXQ2008-08-15
1884311180424890K072449CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHSDPS2007-11-29
1884312062848284K070204LINK TO ACUITY CLINICIAN NOTIFIERMSX2007-03-23
1883651626137425K070060WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE)DXQ2007-12-18

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DPS232016-01-06
DXQ202025-12-16
MWI132024-12-20
DXN92019-04-09
HLI92001-01-25
MHX72018-09-04
DQA62008-09-24
DQK52018-07-30
FLL52016-03-01
BZG42019-09-10
MLO42005-09-26
FSR42003-08-11
DRT42002-07-23
FER41981-02-19
FAM41979-04-23
HKI32023-03-15
CBK32017-08-11
DSI32012-04-10
ONZ32010-12-02
NHJ22020-02-14
DRG22019-01-24
NFJ22018-07-16
MWJ22016-02-26
DSH22005-08-24
DRX22003-03-28
ETY21986-06-10
GCW21977-11-22
HIB12012-03-23
DSA12008-05-05
MSX12007-03-23
ISD12006-04-27
MLD11997-11-07
HEX11996-05-07
FLS11996-02-02
FMT11994-07-01
HLS11977-11-09

PMN#

116 records. Showing 1-40. Next

GUDID#

Welch Allyn, Inc. - S2 telemetry transmitter supporting a 4 and 5 wire patient cable for diagnostic quality ECG acquisition and transmission via standard IEEE 802.11a b g n WLAN at 2.4 and 5 GHz , capacitive touch control and menu navigation with 2.8 inch antiglare color display , heart rate display when actively communicating with monitoring node , water resistant protection with IPX4 rating , includes rechargeable Lithium ion battery pack with 32 hour typical runtime, single use clip on pouch and user instructions.

WELCH ALLYN, INC.

2023-08-25

80 records. Showing 1-40. Next