BEUDAMED
    FDA Registration Active 🇺🇸 United States

    WELCH ALLYN, INC.

    Reg #: 1316463 · FEI: 1316463 · Expires 2026
    View on FDA
    Products
    53
    Proprietary Names
    221
    Establishment Types
    4
    Classifications
    53

    Registration Details

    Registration Name
    WELCH ALLYN, INC.
    Registration Number
    1316463
    FEI Number
    1316463
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    4341 STATE STREET RD.
    City
    Skaneateles Falls
    State
    NY
    ZIP
    13153
    Country
    US

    Regulatory Submissions

    510(k) Number
    K142356

    Owner / Operator

    Firm Name
    BAXTER HEALTHCARE CORPORATION
    Operator Number
    1417572
    Address
    One Baxter Parkway
    City
    Deerfield
    State
    IL
    Postal Code
    60015
    Country
    US
    Correspondent
    Maha Nolasco

    Products

    Device Name Product Code
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Laryngoscope, Rigid CCW
    Device, Medical Examination, Ac Powered KZF
    Blood Pressure Cuff DXQ
    Transformer, Endoscope GCW
    Electrocardiograph DPS
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Spirometer, Diagnostic BZG
    Refractometer, Ophthalmic HKO
    Ophthalmoscope, Ac-Powered HLI
    Electrocardiograph, Ambulatory, With Analysis Algorithm MLO
    Camera, Ophthalmic, Ac-Powered HKI
    Anoscope And Accessories FER
    Transilluminator, Battery-Powered HJN
    Test-Pattern, Radiographic IXF
    Digitizer, Image, Radiological LMA
    Clinical Electronic Thermometer SDV
    Ophthalmoscope, Battery-Powered HLJ
    Scale, Platform, Wheelchair INF
    Loupe, Binocular, Low Power HJH
    Light, Headband, Surgical FSR
    Exophthalmometer HLS
    System, Image Management, Ophthalmic NFJ
    Audiometer EWO
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Computer, Diagnostic, Programmable DQK
    Sigmoidoscope And Accessories, Flexible/Rigid FAM
    Speculum, Vaginal, Nonmetal HIB
    Oximeter DQA
    Continuous Measurement Thermometer FLL
    Retinoscope, Battery-Powered HKM
    Camera, Ophthalmic, General-Use PJZ
    System, Network And Communication, Physiological Monitors MSX
    Detector And Alarm, Arrhythmia DSI
    Plethysmograph, Impedance DSB
    Monitor, St Segment With Alarm MLD
    Alarm, Blood-Pressure DSJ
    Bulb, Inflation, For Endoscope FCY
    Scale, Stand-On, Patient FRI
    Exerciser, Measuring ISD
    Holder, Ear Speculum JYK
    Otoscope ERA
    Recorder, Magnetic Tape, Medical DSH
    Scale, Patient FRW
    Electrocardiograph, Ambulatory (Without Analysis) MWJ
    Stand, Instrument, Ophthalmic, Battery Powered NOI
    Tester, Auditory Impedance ETY
    Compressor, Air, Portable BTI
    Continuous, Ventilator, Home Use NOU
    Ventilator, Continuous, Facility Use CBK
    Stethoscope, Manual LDE
    Monitor, Breathing Frequency BZQ
    Stand, Instrument, Ac-Powered, Ophthalmic HMF

    Proprietary Names

    901057 Spot Vital Signs 4400 Rigid Laryngoscope - Fiber Optic Laryngoscopes, standard laryngoscope and accessories TruLight 1000 Examination Light and accessories [Baxter] Green Series Exam Lights (Light IV, 300, 600, 900) and Accessories [a Welch Allyn, Inc. Tijuana Product] Sphygmomanometers Bronze Series - DS44, DS54 Aneroids and accessories Gold Series - DS56, DS66 Aneroids and accessorie Durashock Sphygmomanometers and accessories Blood Pressure Cuff- Durashock Sphygmomanometers multiple and Accessories Silver Series - DS45, DS55, DS65 Aneroids and accessories Platinum Series - DS58, DS48, DS48A Aneroids and accessories Service Parts Only 767 Integrated Wall Systems and Wall Transformer Sets, Accessories Quinton CR60/TM65 Treadmill X-Scribe / XScribe Stress Exercise Testing System Quinton Q-Stress Stress Exercise Testing System Sleeve Cuff Kit ABPM 6100 Sleeve Cuff, various sizes ABPM 6100 service only Welch Allyn Diagnostic Cardiology Suite Welch Allyn Diagnostic Cardiology Suite - Spirometry 901128 CARDIOPULMONARY ECG SYSTEM Welch Allyn Diagnostic Cardiology Suite - ECG Medikro Spirometer Kits & accessories (410027, 410370, 720705, 720706, 720707, 100680, 720704, 720708, 720855) CP 150 Electocardiograph Devices and accessories Spot Vision Screener (901029) VS100 Vision Screener (901029) Ophthalmic Refractometer Devices - Spot VS100 and SureSight Series and accessories AC Powered Ophthalmoscope - BIO Binocular Indirect Ophthalmoscope and accessories H-Scribe 5 Holter Analysis system Hscribe Holter Analysis System H-Scribe Holter Analysis System iExaminer system with Panoptic Plus Burdick ELI 230 /BUR 230 Electrocardiograph ELI 230/ELI 230 Electrocardiograph/ ELI 230 Cardiograph Anoscope and/or accessories - Disposable Anoscope ELI 250c / ELI 250Rx Electrocardiograph Burdick ELI 250c/Burdick 250c Electrocardiograph BUR 250c Batter Powered Transilluminator - Fiber Optic Transilluminators and accessories iExaminer Resolution Test Card - for OTOSCOPE iEXAMINER APP iOS for Otoscope iEXAMINER APP ANDR for Otoscope SureTemp Plus Probes and Probe Covers; Electronic Thermometry BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES MODEL 6021791-PRO 4000 SERIES, 6022790-IRT 4000 SE Battery Door (EU) Pro6000 Bulk Pack 4th ed SureTemp Plus Electronic Thermometers (690 & 692 Series) and Accessories Thermometer Avita 410671 Care Temp Touch Free Thermometer Accessories 901094 Non Contact Thermometer PRO6000 Small Cradle & Charge Doc EU Thermometer, electronic, clinical Thermometer with Charge Dock; 6' Tether for PRO 6000 Care Temp Touch Free Thermometer #105801 Thermometer Charge Dock Only Braun Thermoscan Pro 6000 Battery Door (US) Therm w/ large cradle 4th ed Them w/ large cradle PRO6000 Bulk Pack Probe Covers 9' Tether for PRO6000 PRO6000 Small Cradle PRO6000 Large Cradle Rechargeable Battery PRO6000 PRO6000 Charge Station (US) Ophthalmoscope, battery-powered Stow-A-Weigh Wheelchair Scale Oversized Wheelchair Scale Wheelchair Scale Bariatric Wheelchair Scale Stow-A-Weigh Stretcher Scale Loupe, Binocular, Low Power - Flat Surface Magnifier, LumiView Portable Binocular Microscope Accessories Green Series Portable Headlights - Solid State Portable Headlight and accessories Pocket LED Ophthalmoscope Ophthalmoscope and Accessories Pocket Scope Ophthalmoscope Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) Universal Desk Charger for Lithium Ion and NiCad Handles, P/N 71110, 71140 Series Accessories - Ophthalmoscope (e.g., PanOptic, etc.) and Otoscope (e.g., MacroView, etc.) RetinaVue Network Reusable One-piece, Soft Disposable One-Piece, Vinyl Disposable One-Piece and accessories Flexiport Blood Pressure Cuffs and accessories ELI 380 Electrocardiograph / ELI 380 / ELI 380 Cardiograph ELI 380 ERGO GS777 Integrated Wall Systems w/117 LED Ophthalmoscope Diagnostic Set w/117 LED Ophthalmoscope AC Powered Ophthalmoscope Devices - Compacset Dignosics Set, Klinic Ophthalmoscopes, Various Models and accessories; 117 Audiometer Devices - AudioScope 3 Screening Audiometer and accessories Welch Allyn Connex Central Station (Connex CS) v. 1.8.7 Model 901066 Monitoring Station Welch Allyn Connex Central Station (Connex CS) v. 1.8.5 Epiphany Cardio Server Mobile Connex Cardio R-Scribe Electrocardiograph Cardiac Monitor (Including Cardiotachometer And Rate Alarm) FlexiPort EcoCuffs and accessories (ECOCUFF-09, -10, -11, -12, -MLT) Two-Piece Blood Pressure Cuffs and accessories Tycos 509 Wall and Mobile Aneroids and accessories 767 Wall & Mobile Aneroids and Accessories One-Piece Disposable Neonate Blood Pressure Cuffs and accessories Endoscope and/or accessories - Disposable Sigmoidoscope 800 Series Cordless Illumination System Obstetric-gynecologic Specialized Manual Instrument - KleenSpec Single Use Vaginal Speculum 790 Series Cordless Iluminator and wire Illuminator KleenSpec Disposable Vaginal Speculum and accessories Oximeter, Thermometer and accessories; ProBP 3400 Series and accessories Blood Pressure Non-invasive Measurement System, Devices and accessories Battery Powered Retinoscope Devices - Elite Streak and Spot Retinoscopes i-Examiner (Panoptic Ophthalmosope and iPhone) and Accessories RV700 RV100 Pro RV100 RetinaVue 700 Imager Eye-Fundus Camera - RetinaVue 100 Imager Spot Vision Screener Surveyor S19 Anoscope and Accessories - Fiber Optic Anoscope, Op77E Rating Anoscope, Rotating Anoscope, Standard Anoscope Endoscope Inflation Bulb - Endoscope Insufflation System and accessories Connex Central Station (Connex CS), Model 901066 Monitoring Station and Connex CS Accessories Accessories - Software and Hardware Blood Pressure Cuffs- Omni-Kuff and accessories iExaminer (PanOptic Ophthalmoscope and iPhone) and accessories Bariatric Stand-On Scale [Skan spec dev] Mobile Bariatric Stand-On Scale [Skan spec dev] and accessory Height Gauge Geriatric Physician's Stand-On Scale Mobile Stand-On Scale [Skan spec dev] and accessory Height Gauge T-RPM-SCALE100 [Skan contr. mfg] TAA Remote Monitoring Scale [Skan contr. mfg] In-Floor Stand-On Scale [Skan spec dev] Low-Profile Stand-On Scale [Skan spec dev] Portable Stand-On Scale [Skan spec dev] Physician's Stand-On Scale Stow-A-Weigh Stand-On Scale [Skan spec dev] ERGOSELECT 100 K/P, ERGOSELECT 200 K/P Burdick ELI 280/BUR 280 Electrocardiograph McKesson Lumeon Series Burdick ELI 280 ELI 280 Electrocardiograph / ELI 280 Cardiograph Dispenser for 524 Series Disposable Ear Spec Pulmonary Server ECG Management System Cardio Server ECG Management System Digital MacroView, MacroView, 3.5V Diagnostic, Pneumatic, Op77E-Rating, PocketScope, Pocket Jr. Welch Allyn MacroView Plus Oto for iEx Welch Allyn MacroView Plus iExaminer Kit Welch Allyn LumiView Clear Single-Use Ear Specula Pocket LED Otoscopes (multi-colors) and accessories Welch Allyn LED Otoscope Compacset Portable Dignostic Set, Lumiview w/Various Transformer Sets and Accessories Welch Allyn MacroView Basic Otoscope Reusable and Disposable Specula,Dispensers Otoscope and Accessories BLK Pocket LED Otoscope H12+ Holter Recorder Braun Thermoscan PRO 6000 Ear Thermometer Omni cuffs and accessories Blood Pressure Cuffs- Balanced Nylon Bladders and accessories OEM Products - Ambulatory with Analysis Algorithm Devices, Holter Series and accessories GI Holter GI100, 1200, 300; HR 100, HR 1200, HR 300, Welch Allyn Holter Recorder and accessories Endoscope and Accessories - Anoscope rigid, Insufflation System Sigmoidoscope/Anoscope Lighting System and accessories Signoidoscope rigid and Insufflation System Non-electrical Sigmoidoscope, Fiber Optic Sigmoidoscope and accessories Chair Scale Under Bed Pod Scale Flush Mounted In-Floor Scale Sling Scale Under Chair Dialysis Scale Organ / Tissue Scale Pediatric / Infant Scale Diaper / Specimen Scale H3+ Holter Recorder Welch Allyn Universal Desk Charger with Lithium-ion Handles 719-USB USB POWER SUPPLY,5V,1.4A,USB-A 719-3 Li-Ion Plus USB Handle for Desk Charger 719-DSK Welch Allyn Universal Desk Charger Welch Allyn PanOptic Plus Oph US PanOptic Basic & Plus Eye Cup (set of 5) GS777 Integrated Wall Systems w/PanOptic Plus Ophthalmoscope Premium Diagnostic Sets w/PanOptic Plus Standard Diagnostic Set w/Ophthalmoscope GS777 Integrated Wall Systems w/LED Ophthalmoscope AC/DC Powered Ophthalmoscope - 117 Series Ophthalmoscope, 118 Series Ophthalmoscope and accessories Welch Allyn PanOptic Basic Oph US Desk Sets w/PanOptic Plus Diagnostic Sets w/PanOptic Plus Accessory Enhanced Diagnostic Sets w/PanOptic Plus Auditory Impedance Devices - MicroTymp2, MicroTymp3 and accessories ELI 150Rx / ELI 150RX / ELI 150c / ELI 150c Rx Electrocardiograph / ELI 150c Cardiograph Burdick ELI 150c/BUR 150c Electrocardiograph McKesson Lumeon Series Burdick ELI 150c Electrocardiographs Devices - Cardioperfect Workstand (software and hardware) multiple & accessories Spirometer, Resting, Stress ECG systems 901060 Vital Signs Monitor Patient Physiological Monitor - Welch Allyn Connex Vital Signs Monitor (CVSM) and accessories Welch Allyn Connex Vital Signs Monitor 6000 Series (64xx, 65xx, 67xx and 68xx) and accessories Welch Allyn Connex Vital Signs Monitor with ECG Welch Allyn Connex Integrated Wall System Welch Allyn Connex Integrated Wall System (CIWS-84 Series and 85 Series) and accessories Life2000 Ventilation System Disposable Uniscope Stethoscopes [WASuz] Trimline Disposable and Trimline Isolation Stethoscope [WAMDF] Harvey DLX and Harvey Elite Stethoscope [WASkn] Professional Stethoscope [WASkn] Lightweight Stethoscopes [WAADC] Trimline Blood Pressure Cuffs & Disposable Tempa-Kuffs Blood Pressure Cuff 39000 series Blood Pressure Cuff Trimline Universal Connectivity Kit Welch Allyn Connex® Spot Monitor Patient Physiological Monitor - Connex Spot Monitor (CSM) Devices and accessories 901058 Vital Signs Monitor Core and accessories TANGO M2 BLOOD PRESSURE MONITOR Vital Signs Connex Software and accessories AC Powered Instrument Stand - 777 Wall Transformer AC Powered Instrument Stand - 777 Wall Transformer Set (including Otoscopes, Ophthalmoscope) and accessories #156-3 & 156-4

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198