ConMed Corporation

FDA Device Registration & Listing · Greenwood Village, CO, US · Registration 3004491689

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
3004491689
FEI Number
3004491689
Entity Name
ConMed Corporation
City/State/Country
Greenwood Village, CO, US
Establishment Address
6363 S Fiddlers Green Cir Ste 1400, Greenwood Village, CO 80111, 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
PMA Number
N/A

All Registered Proprietary Names

Core Trumpet Accessory Electrode Universal Plus Straight Blade Electrosurgical Electrode Needle Electrosurgical Electrode Extended Blade Electrosurgical Electrode Loop Electrosurgical Electrode core puddle vac Ball Electrodes Loop Excision Electrodes 3 Liter Pressure Infusor System 2450 ESU and Accessories ABC Laparoscopic Probe AnchorPort Core Anchor Tissue Retrieval System System 5000 ESU and accessories Reusable Grounding Pad Cable Dispersive Electrode Adapter Core Dynamics Macrolyte Core DetachaTip AirSeal dV Solution AirSeal iFS System Core DetachaTip Instrument Tray CONMED Laparoscopic Scissors HelixAR Loop Excision Electrode Core Trumpet ABC Surgical Laser Mask Core Linvatec Pin Index Yoke Mounted Valve HP Pin Index Yoke 1m HP Pin Index Yoke with Gauge 1m Switching Valve w/ hoses and mounting bracket iFS House Gas Switching Valve PlumePort Harmony AIR ViroSafe ABC Footswitch Footswitch, Bipolar Universal Plus Reflex VARIOUS ENDOSCOPIC PROB Core Dynamics LaparoVue VueTip OnePort ViroSafe ConMed Stealth Electrode Goldline handpieces/Pencils Thermogard Core AirSeal iFS System BiCap Superconductor Excel Reflex ABC Flex Probes Core Dynamics VCare Dx Plus VCare Dx Universal Plus ES FloVac VisiClear PlumeVac EZLink SHE SHA OR-VAC Bovie FUMOVAC QUIKLINK HarmonyAIR Vacuum hose holder stand Reflex Smoke Plume Altrus GoldVac ViroSafe Bend A Beam VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) VCARE Plus Reflex Core Dynamics DetachaPort Macrolyte Dflex Smoke Evacuator Accessories ConMed 1200 Smoke Evacuator Sys. ConMed 1000 Smoke Evacuator Sys. ViroVac StrykeVac Clearview smokeSTAR HyfreVAC PlumeVac FUMOVAC Universal Plus Universal Plus LaseADAPT OR-VAC FUMOVAC PLUMEPORT HarmonyAIR Core Examine Core Dynamics ViroSafe MicroSafe PlumeGuard smokeSTAR OR-VAC SHE SHA AIR SAFE SkyVac FUMOVAC Smoke Shark HarmonyAIR SnapEvac PlumePen PenAdapt Neptune TeleVac EDGE S.A.F.E. ViroSafe 1000 SES Stackhouse Phoenix Optimumm VCARE CORE E3 Reusable Bipolar Forceps Monopolar Forceps AIrseal 1 Liter Pressure Infusor Dual 1 Liter Pressure Infusor Infusor Compressor MEP-1 Anchor Tissue Retrieval System Core TroGard Finesse Core SelectOne HelixAR ABC System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GBW Catheter, Peritoneal General, Plastic Surgery Class 1 878.4200 2010-04-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2011-12-08
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2009-11-11
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2015-03-03
GAZ Tubing, Noninvasive General Hospital Class 2 880.6740 2013-03-29
HGI Electrocautery, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.4120 2008-04-22
FRN Pump, Infusion General Hospital Class 2 880.5725 2010-07-29
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 2015-10-30
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2016-02-15
HES Insufflator, Carbon-Dioxide, Uterotubal (And Accessories) Obstetrics/Gynecology Class 2 884.1300 2011-05-12
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2017-08-04
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 2013-08-07
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2010-06-09
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2010-06-17
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2010-04-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2009-12-03
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-02-12
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2024-02-12
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2010-06-15
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2010-03-10
KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) Obstetrics/Gynecology Class 2 884.4160 2009-11-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-10-06
HGI Electrocautery, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.4120 2015-03-09
GAZ Tubing, Noninvasive General Hospital Class 2 880.6740 2009-11-11
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2014-11-10
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2019-10-07
FBM Cannula And Trocar, Suprapubic, Non-Disposable Gastroenterology, Urology Class 1 876.5090 2010-05-10
NKC Tubing/Tubing With Filter, Insufflation, Laparoscopic Obstetrics/Gynecology Class 1 884.1730 2013-05-31
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2019-10-07
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2010-01-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2010-01-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2010-05-20
FZQ Clip, Removable (Skin) General, Plastic Surgery Class 1 878.4320 2019-06-14
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2006-06-13
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2019-10-07
OCT Anti Fog Solution And Accessories, Endoscopy Gastroenterology, Urology Class 2 876.1500 2019-10-07
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2009-10-23
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2019-10-07
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2009-11-06
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2008-04-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2014-09-12
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2016-08-19
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2016-01-29
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2016-01-29
FEH Electrode, Flexible Suction Coagulator Gastroenterology, Urology Class 2 876.4300 2010-06-28
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2010-05-10
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2010-04-13
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2014-04-24
FBM Cannula And Trocar, Suprapubic, Non-Disposable Gastroenterology, Urology Class 1 876.5090 2010-06-15
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2010-03-17
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2009-11-12
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2009-11-11
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2019-10-07
FOX Stand, Infusion General Hospital Class 1 880.6990 2019-10-07
QQS Stapler, Skin General Hospital Class 1 878.4740 2022-05-04
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2010-01-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2014-07-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2010-01-20
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2019-10-07
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2010-04-08
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2015-02-11
HBT Applier, Hemostatic Clip General, Plastic Surgery Class 1 878.4800 2010-02-15
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2010-04-16
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2010-03-26
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2010-03-26
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2012-08-23
JOS Electrode, Electrosurgical General, Plastic Surgery Class 2 878.4400 2012-08-23
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-12-01
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2008-04-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2009-11-12
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2009-11-11
GAZ Tubing, Noninvasive General Hospital Class 2 880.6740 1994-02-24
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2010-06-15
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2010-06-09
FHO Pneumoperitoneum Needle Gastroenterology, Urology Class 2 876.1500 2008-02-12
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2019-10-07
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-05-17
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2023-05-17
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2019-10-07
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2009-09-21
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2021-10-08
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2012-12-07
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2015-06-12
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2018-04-23
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2018-04-23
FRN Pump, Infusion General Hospital Class 2 880.5725 2010-07-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-05-24
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2017-10-24
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2010-06-16
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2009-10-22
FEC Obturator, For Endoscope Gastroenterology, Urology Class 2 876.1500 2010-06-15
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2010-06-15
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2009-11-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-01-22

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
1223925 Conmed Corporation WESTBOROUGH, MA, US
1017294 Linvatec Corporation LARGO, FL, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17
K002257 Tecno Instruments (Pvt.) , Ltd. TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 2000-10-19
K193591 Bowa-Electronics GmbH & Co. KG ARC 400 2020-04-02
K192128 Sutter Medizintechnik GmbH Sutter Arrowtip Monopolar Electrodes 2019-10-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0027-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
Z-0008-2013 Gynex Corporation 2
Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. Label reads in part "***GYNEX*** Electrode Handpiece, Foot Activated*** Manufactured for GYNEX***" Gynex catalog number: 950 (Gynex REF 950, Electrode Handpiece) It connects the electrode to the food activated electric generator. Electrodes are used in gynecological procedures, in a physician's office, for cutting to remove tissue and coagulation to control bleeding by the use of high frequency current.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004491689. Last updated year: 2026. Please use registration number 3004491689 when referencing this establishment in official correspondence.
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