Conmed Corporation

FDA Device Registration & Listing · WESTBOROUGH, MA, US · Registration 1223925

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1223925
FEI Number
1000305720
Entity Name
Conmed Corporation
City/State/Country
WESTBOROUGH, MA, US
Establishment Address
134 Flanders Rd, WESTBOROUGH, MA 01581, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
CONMED CORPORATION (Owner Number: 1317214)
Owner / Operator Contact Address
11311 Concept Boulevard, --, Largo, FL 33773, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K945034
PMA Number
N/A

All Registered Proprietary Names

Dynatrace, Snaptrace, e-Trode, Softrace FSR/SRS Series BRAINSTREAM Disposable Deep Cup EEG Electrodes R2 Stieg-Mann Goff Ultratrace PadPro Bite Block, Conmed PadPro Beamer Argon Snare Probe Suction Connecting Tubing Huggables Disposable Microbiology Brush Introducer Accessory Eliminator PET Balloon Dilitation Invisatrace Proforma Hyfrecator Reusable Pencil Bipolar Cord Clearsite PadPro Harrel R Series Precisor Precisor Totaltrace ConMed Tens Electrode PADPRO MULTI-FUNCTION ELECTRODES Whistle Channel Master Suction Connecting Tubing Beamer AVEO™ FILTER INTEGRATED ARGON PROBES, Beamer AVEO™ FILTER INTEGRATED ARGON SIDEFIRE PROBE Singular Optimizer PadPro Stat2 PADPRO MULTI-FUNCTION ELECTRODES Multi-Link VENI-GARD SECUREMENT DEVICES SureTrace Hyfrecator 2000 ESU and Accessories Hyfrecator #733 PadPro Entake Standard & Safety PEG System Stat 2 Pumpette Infant Arm Support with Cover Adult Arm Support with Cover Child Arm Support with Cover Fastrace, Heartbeat, VTrace SnapTrace American Dilation System CleanGuide Veni-Gard/Neoderm Needle Tip Cytology Brush Electrode Cable Stiegmann-Goff Bandito Steigmann-Goff Eliminator Veni-Gard Axcess Papillotomes Apollo Papillotomes Nakao Spider-Net Retrieval Device D Series

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2008-03-14
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2010-08-19
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2020-06-02
LDD Dc-Defibrillator, Low-Energy, (Including Paddles) Cardiovascular Class 2 870.5300 2010-03-03
MND Ligator, Esophageal Gastroenterology, Urology Class 2 876.4400 2006-02-27
FHN Ligator, Hemorrhoidal Gastroenterology, Urology Class 2 876.4400 2006-02-27
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2009-11-18
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2009-10-23
MNK Endoscopic Bite Block Gastroenterology, Urology Class 1 876.1500 2010-06-02
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2009-10-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2008-07-23
BYY Tube, Aspirating, Flexible, Connecting General Hospital Class 2 880.6740 2010-06-02
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2009-10-23
BTG Brush, Biopsy, Bronchoscope (Non-Rigid) Ear, Nose, Throat Class 2 874.4680 2006-02-27
FGY Cannula, Injection General, Plastic Surgery Class 1 878.4200 2010-06-01
KNQ Dilator, Esophageal Gastroenterology, Urology Class 2 876.5365 2006-02-01
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2009-11-18
ODD Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula Gastroenterology, Urology Class 2 876.1500 2009-10-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2009-09-24
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2010-01-21
NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic General, Plastic Surgery Class 1 878.4022 2010-06-16
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2009-10-22
GEE Brush, Biopsy, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2006-11-13
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2010-06-29
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2012-01-31
KGE Forceps, Biopsy, Electric Gastroenterology, Urology Class 2 876.4300 2007-03-12
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2020-01-20
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2013-05-10
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2006-06-15
MNL Accessories, Cleaning Brushes, For Endoscope Gastroenterology, Urology Class 1 876.1500 2012-04-25
BYY Tube, Aspirating, Flexible, Connecting General Hospital Class 2 880.6740 1992-06-27
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-08-24
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2006-02-27
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2006-02-27
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2021-11-05
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2011-04-05
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2006-06-15
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2010-08-19
KMK Device, Intravascular Catheter Securement General Hospital Class 1 880.5210 1992-06-27
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2009-12-16
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2008-04-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2010-01-21
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2013-11-14
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 1994-09-15
LDR Controller, Infusion, Intravascular, Electronic General Hospital Class 2 880.5725 2011-04-05
NOD Board, Arm (With Cover), Non-Sterile General, Plastic Surgery Class 1 878.3910 2013-05-31
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2009-11-19
KNQ Dilator, Esophageal Gastroenterology, Urology Class 2 876.5365 2006-02-01
OCY Endoscopic Guidewire, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2019-07-19
MGP Dressing, Wound And Burn, Occlusive Unknown Class U N/A 2009-11-05
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2009-10-29
IKD Cable, Electrode Physical Medicine Class 2 890.1175 1992-06-27
MND Ligator, Esophageal Gastroenterology, Urology Class 2 876.4400 2006-02-27
FHN Ligator, Hemorrhoidal Gastroenterology, Urology Class 2 876.4400 2006-02-27
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2006-02-27
KMK Device, Intravascular Catheter Securement General Hospital Class 1 880.5210 2010-06-16
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2008-07-23
FGX Snare, Non-Electrical Gastroenterology, Urology Class 1 876.4730 2006-05-30
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2010-08-06

Official Correspondent

Brent Lalomia

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CONMED CORPORATION
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3019101334 ConMed Corporation New Haven, CT, US
3007305485 Consolidated Medical Equipment Company Chihuahua, MX
1320894 CONMED CORPORATION Utica, NY, US
3004491689 ConMed Corporation Greenwood Village, CO, US
1017294 Linvatec Corporation LARGO, FL, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K193606 Conmed Corporation Y-Knot OneStep Anchor 2020-01-22
K934333 3M Medical Products Group 3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE 1994-07-07
K880323 Medtronic Vascular MEDTRONIC MODEL 5411 SURGICAL CABLE ADAPTOR 1988-03-22
K070612 Top-Rank Health Care Equipment Co., Ltd. TOP-RANK ADHESIVE ELECTRODE 2007-05-07
K123915 Grass Technologies, an Astro-Med, Inc. Product Gro DE48-PLUS 2013-04-24

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0557-2025 Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom 2
Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode
Z-0564-2021 Remote Diagnostic Technologies Ltd. PAVILION C2, ASHWOOD PARK ASHWOOD WAY Basingstoke United Kingdom 2
Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage: The device is intended to be used in the following environmental: - Primarily in pre-hospital care and transport applications (including ambulances, fixed and rotary wing aircraft).
Z-0861-2022 Remote Diagnostic Technologies Ltd. PAVILION C2, ASHWOOD PARK ASHWOOD WAY Basingstoke United Kingdom 2
Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Z-1825-2023 Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom 2
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
Z-2028-2024 Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom 2
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1223925. Last updated year: 2026. Please use registration number 1223925 when referencing this establishment in official correspondence.
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