CONMED CORPORATION

FDA Device Registration & Listing · Utica, NY, US · Registration 1320894

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
1320894
FEI Number
3001451571
Entity Name
CONMED CORPORATION
City/State/Country
Utica, NY, US
Establishment Address
525 French Rd, Utica, NY 13502, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
CONMED CORPORATION (Owner Number: 1317214)
Owner / Operator Contact Address
11311 Concept Boulevard, --, Largo, FL 33773, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K942215
PMA Number
N/A

All Registered Proprietary Names

Core Dynamics Whistle Channel Master Y-Knot OneStep Anchor Axcess Papillotomes Apollo Papillotomes BioBrace Extra-Articular Ligament Augmentation Kit Reflex System 5000 ESU and accessories AirSeal iFS System Y-Knotless™ Flex Anchors Reflex Altrus Contour Meniscus Arrow AirSeal Thermogard Bone Fixation Powerpoint Pencil Stieg-Mann Goff Reusable Bipolar Forceps Universal Plus Proforma HF ABC ConMed Stealth Electrode Asp-Irrator Bone Fixation EDGE Bi-Polar Arthroscopic RF System Arthroscopic Energy System Low Impact Handcontrol - Bipolar Forceps Footcontrol - Bipolar Forceps Forcep Accessories ConMed Tens Electrode Harrel CleanGuide Universal Plus VCARE Argo Knotless Genesys Anchors ViroSafe PadPro HALL DRILL REAM ATTACHMENT POWERPRO UNIVERSAL CABLE POWERPROMAX DRIVER ATTACHMENT ADVANTAGE 2 PowerPro Attachments C-SERTER MICRO 100 TUBING 10K, Linvatec Totaltrace Ball Electrodes Loop Excision Electrodes PadPro Endoscopic Overtube ConMed CleanGuard Core Gold T.U.R. Cable Monopolar Cable Anchor Tissue Retrieval System by CONMED HandStand Core Core CleanGuard Beamer AVEO™ Electrosurgical Generator, Beamer AVEO™ Argon Module, Beamer AVEO™ Cart, Beamer AVEO™ Wired Foot Pedal BioBrace Reinforced Implant Maciol Lap Suture Set Genesys Matryx V-Trace ABC Handpieces/Accessories D Series Anchor Bag-Alone Footswitch, Bipolar Hyfrecator, Electrolase Pivotal Graspers Dispersive Electrode Adapter MacroLyte Dispersive Electrode MICROCHOICE MINI DRIVER HANDPIECE MINOS HANDPIECE RETRACTOR GUARD SAGITTAL SAW Surgairtome II BUR GUARD UltraPower HALL SERIES 3 OSCILLATOR Excalibur SelectOne Universal Plus Genesys Matryx Electrosurgical Handpiece Veni-Gard/Neoderm Brush Cytology Reflex Examine Core MEP-1 LaparoVue VueTip Eliminator PET Balloon Dilitation ABC Anchor Tissue Retrieval System Accessory Electrode Core Dynamics Disposable Microbiology Brush Bipolar Coagulating Forceps PADPRO MULTI-FUNCTION ELECTRODES Excel Smartpin Frazier ViroSafe Neptune TeleVac EDGE S.A.F.E. ViroSafe 1000 SES Stackhouse Phoenix Optimumm CANNUAL SHAFT CANNULA TIP CANNULA Grasper Core Reusable Dispersive Electrode Reusable Pediatric Dispersive Electrode Reusable Grounding Pad Cables 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 Eliminator PadPro Core ViroSafe DetachaPort VisiClear PlumeVac EZLink SHE SHA OR-VAC Bovie FUMOVAC QUIKLINK HarmonyAIR TroGard Disposable Bipolar Cable CORE Cleartrace, Profile, Suretrace, Positrace Core Trumpet Core Dynamics Versa-Stim Universal Plus AirSeal dV Solution AirSeal iFS System Arthoscopy ES Electrode Beamer Argon Snare Probe Huggables VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) VCARE Plus ECOM American Dilation System HelixAR ABC System Holster Sure Shot Proforma Argo Knotless Suction Connecting Tubing VENI-GARD SECUREMENT DEVICES Loop Excision Electrode Ultratrace PADPRO MULTI-FUNCTION ELECTRODES Core OnePort Paradigm TroGard Finesse Reflex Gynecare Versascope TruShot with Y-Knot FloVac Handcontrolled suction VP1005 Video Tray Single Level (RADEL) VP1003 Video Extended Length Tray (RADEL) VP1007 Video Laparoscope Tray (RADEL) VP1006 Video Arthroscope Tray (RADEL) EntriPort Surgical Trocar System SnapEvac PenAdapt Foot Control Exactrace Instatrace Bite Block, Conmed ExoShape BRAINSTREAM Disposable Deep Cup EEG Electrodes Flextip ExoShape Beamer ConMed MicroLink MicroLink Proforma Neotrode Cleartrode, Softrace SureTrace ConMed Mixing and Delivery Kit ConMed Irrigation Nozzle Expose Retractor Precisor Core Dynamics Straight Blade Electrosurgical Electrode Needle Electrosurgical Electrode Extended Blade Electrosurgical Electrode Loop Electrosurgical Electrode HD EYECUP SCOPE HD CARTRIDGE SCOPE HD EYECUP CARTRIDGE LAPAROSCOPE HD EYECUP LAPAROSCOPE Clear Guard Universal Plus ABC Genesys Matryx Viking Smartnail Veni-Gard Universal Modular Cart Cord Wraps FIXATION STRAP STRESS POST LEG STABILIZER STABILIZER BALL Universal Cart Strap Universal Modular Base Cart Next Generation X Wire Guidewire Core LocaLisa R Series Broncho Smoke Evacuator Accessories ConMed 1200 Smoke Evacuator Sys. ConMed 1000 Smoke Evacuator Sys. ViroVac StrykeVac Clearview smokeSTAR HyfreVAC PlumeVac FUMOVAC AirSeal® Bifurcated Filtered Tube Set AirSeal® Cannula Cap AirSeal dV Solution AirSeal Robotic Solution ABCFlex Flexible Endoscopy Probes System 7550 ABC ESU DetachaTip DuraGlide Hand-Trol Surgical Camera BiCap Superconductor Expose Retractor Macrolyte Nakao Spider-Net Retrieval Device Stat2 SelectOne CUFFLINK Softee Reflex 1 Liter Pressure Infusor Dual 1 Liter Pressure Infusor Infusor Compressor Fastrace, Heartbeat, VTrace SnapTrace Suction Connecting Tubing Infant Arm Support with Cover Adult Arm Support with Cover Child Arm Support with Cover Airsoft Patient Positioner Puncture Closure Device DetachaTip ViroSafe Beamer AVEO™ FILTER INTEGRATED ARGON PROBES, Beamer AVEO™ FILTER INTEGRATED ARGON SIDEFIRE PROBE CORE E3 BioBrace® Reinforced Implant DetachaTip Instrument Tray FIT Biliary Stone Balloon CONMED Laparoscopic Scissors Wang Core Precisor Universal Plus Clearvac Ace 25 Biliary Guidewire HSW Laparoscopy Set SurgiQuest Laparoscope BiCapIII Sabre Genesis Hyfrecator Reflex Disposable Bipolar Cord Reusable Bipolar Cord Excel Bend A Beam Looking Glass™ Camera and Console Reflex CUFFLINK Electronic Light Guide PadPro Stat 2 Pumpette Surgical Laser Mask System 2450 ESU and Accessories Macrolyte Singular Optimizer CONMED Laparoscopic Electrode Dynatrace, Snaptrace, e-Trode, Softrace GoldVac Touch Glass PadPro Aer Defense SMARTPIN DRILL BIT Y-Knot BADGER CANNULATED POPLOK DRILL BIT REVO DRILL BIT Y-KNOT DRILL BIT IMPACT DRILL BIT SENTINEL DRILL BIT BADGER DRILL BIT SMARTPIN Pinn-ACL MIN-REVO DRILL BIT MICROMITE DRILL E9000 BUR SMARTNAIL ULTRAFIX DRILL Y-KNOT FLEX DRILL BIT MICROLINK INFINITY Smartpin Backpads Strippers Multi-Link True HD 3MOS Camera System HelixAR AspenVAC ULPA/Charcoal Filter Buffalo Filter MICROMITE INSTRUMENT TRAY TUNNEL DILATOR GRAFIX GRAFT INSTRUMENT TRAY PINN ACL DROSSPIN E9000 BUR RACK UPPERARM STRAP MINI-REVO INSTRUMENT CASE BULLSEYE TRAY AUTOCLAVABLE TRAY INSTABILITY TRAY BIO INSTABILITY INTRUMENT TRAY ULTRAFIX INSTRUMENT TRAY RCR INSTRUMENT TRAY BIOANCHOR INSTRUMENT TRAY FOREARM STRAP Pinn-ACL TRAY XO BUTTON HOLDER CRUCIATE RECONST SHUTT MASTER SET TRACTION TOWER COOLING BIN ZONE SPECIFIC INSTRUMENT TRAY MENISCUS INSTRUMENT TRAY HALL MICROFREE HandStand Handcontrol Bipolar Forceps Footcontrol Bipolar Forceps Infinity AIM Zone Specific AIM Bipolar Cord Electronic Light Guide eLUma Linvatec light source Microlap Introducer Reusable Grounding Pad Cable Dispersive Electrode Adapter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FHO Pneumoperitoneum Needle Gastroenterology, Urology Class 2 876.1500 2008-02-12
MNL Accessories, Cleaning Brushes, For Endoscope Gastroenterology, Urology Class 1 876.1500 2012-04-25
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2020-01-24
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2008-07-23
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2025-11-21
OWW Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon General, Plastic Surgery Class 2 878.3300 2025-11-21
OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon General, Plastic Surgery Class 2 878.3300 2025-11-21
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 2008-04-21
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
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2026-01-30
QQS Stapler, Skin General Hospital Class 1 878.4740 2022-05-04
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2014-07-29
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-07-23
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2019-08-06
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2019-08-06
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2008-03-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-07-23
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2011-01-17
MND Ligator, Esophageal Gastroenterology, Urology Class 2 876.4400 2006-02-27
FHN Ligator, Hemorrhoidal Gastroenterology, Urology Class 2 876.4400 2006-02-27
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2012-12-07
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2009-11-12
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2009-10-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2010-01-20
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2009-11-06
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2009-11-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-07-23
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-07-23
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2014-07-23
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2016-12-01
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-12-01
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2008-04-21
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2013-05-10
GEE Brush, Biopsy, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2006-11-13
OCY Endoscopic Guidewire, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2019-07-19
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2009-11-11
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2009-09-21
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-03-28
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2024-03-28
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2019-10-07
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2009-10-22
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2011-02-25
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2020-01-20
HGI Electrocautery, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.4120 2008-04-22
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2021-11-05
FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2009-10-29
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2002-02-07
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2019-06-06
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2010-05-27
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2015-03-09
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2018-09-19
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2020-12-21
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2010-06-15
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2010-04-05
ODC Endoscope Channel Accessory Gastroenterology, Urology Class 2 876.1500 2019-06-06
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2019-06-06
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-09-26
OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon General, Plastic Surgery Class 2 878.3300 2024-06-20
OWW Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon General, Plastic Surgery Class 2 878.3300 2024-06-20
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2010-03-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-07-23
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2009-10-23
HAM Apparatus, Electrosurgical General, Plastic Surgery Class 2 878.4400 2005-12-02
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2010-08-06
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2019-05-30
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 2014-11-10
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2009-11-05
JOS Electrode, Electrosurgical General, Plastic Surgery Class 2 878.4400 2009-08-20
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2009-08-20
GET Motor, Surgical Instrument, Pneumatic Powered General, Plastic Surgery Class 1 878.4820 2014-07-11
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2014-11-25
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2009-11-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-07-23
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-07-23
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2015-03-09
MGP Dressing, Wound And Burn, Occlusive Unknown Class U N/A 2009-11-05
FDX Endoscopic Cytology Brush Gastroenterology, Urology Class 2 876.1500 2005-07-25
FZQ Clip, Removable (Skin) General, Plastic Surgery Class 1 878.4320 2001-09-07
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2010-06-09
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2010-06-15
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 2019-10-07
OCT Anti Fog Solution And Accessories, Endoscopy Gastroenterology, Urology Class 2 876.1500 2019-10-07
KNQ Dilator, Esophageal Gastroenterology, Urology Class 2 876.5365 2006-02-01
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2014-11-10
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 2011-12-08
FBM Cannula And Trocar, Suprapubic, Non-Disposable Gastroenterology, Urology Class 1 876.5090 2010-06-15
BTG Brush, Biopsy, Bronchoscope (Non-Rigid) Ear, Nose, Throat Class 2 874.4680 2006-02-27
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 2006-06-15
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2010-05-10
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2013-07-23
GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered General, Plastic Surgery Class 1 878.4680 2010-03-11
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2019-10-07
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2019-10-07
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2001-01-08
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2015-03-03
NKC Tubing/Tubing With Filter, Insufflation, Laparoscopic Obstetrics/Gynecology Class 1 884.1730 2013-05-31
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2006-02-27
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2009-10-22
FBM Cannula And Trocar, Suprapubic, Non-Disposable Gastroenterology, Urology Class 1 876.5090 2010-05-10
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2019-10-07
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
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2019-10-07
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 2015-01-23
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2010-06-08
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2009-11-18
GBW Catheter, Peritoneal General, Plastic Surgery Class 1 878.4200 2010-04-22
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2010-06-09
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2009-10-23
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 2024-02-12
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2024-02-12
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 2008-07-23
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2009-10-23
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2015-02-11
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2014-03-31
KNQ Dilator, Esophageal Gastroenterology, Urology Class 2 876.5365 2006-02-01
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-01-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2010-01-21
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2014-06-09
ODD Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula Gastroenterology, Urology Class 2 876.1500 2009-10-29
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-05-17
BYY Tube, Aspirating, Flexible, Connecting General Hospital Class 2 880.6740 2010-06-02
KMK Device, Intravascular Catheter Securement General Hospital Class 1 880.5210 1992-06-27
HGI Electrocautery, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.4120 2015-03-09
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2009-11-18
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2006-06-15
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 2009-10-23
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 2022-02-17
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2009-10-22
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2012-02-29
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2012-11-27
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2019-01-09
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2009-11-11
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2014-04-17
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2015-03-06
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 2017-09-19
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2009-11-16
MNK Endoscopic Bite Block Gastroenterology, Urology Class 1 876.1500 2010-06-02
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2020-07-24
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-07-24
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2020-06-02
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2006-02-27
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2020-07-24
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-07-24
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2009-10-29
NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic General, Plastic Surgery Class 1 878.4022 2002-02-07
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2019-07-01
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2019-07-01
ODD Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula Gastroenterology, Urology Class 2 876.1500 2009-10-29
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2010-03-23
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2009-12-16
FMF Syringe, Piston General Hospital Class 2 880.5860 2015-05-07
KPL Colonic Irrigation System Gastroenterology, Urology Class 2 876.5220 2017-02-17
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2016-08-25
KGE Forceps, Biopsy, Electric Gastroenterology, Urology Class 2 876.4300 2007-03-12
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2010-04-16
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2015-03-03
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2014-07-08
ODC Endoscope Channel Accessory Gastroenterology, Urology Class 2 876.1500 2014-06-09
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2009-11-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-07-23
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2013-09-27
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-07-23
KMK Device, Intravascular Catheter Securement General Hospital Class 1 880.5210 2010-06-16
FWZ Operating Room Accessories Table Tray General, Plastic Surgery Class 1 878.4950 2014-07-11
OCY Endoscopic Guidewire, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2009-10-29
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2016-08-19
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2016-03-23
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2010-06-29
GCL Esophagoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2005-08-16
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2008-04-21
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2021-08-19
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2021-08-19
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 2009-12-03
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 1994-09-28
DWG Electrosurgical Device General, Plastic Surgery Class 2 878.4400 2014-08-14
FXM Camera, Still, Endoscopic General, Plastic Surgery Class 1 878.4160 2014-01-24
FEH Electrode, Flexible Suction Coagulator Gastroenterology, Urology Class 2 876.4300 2010-06-28
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2016-08-25
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
FGX Snare, Non-Electrical Gastroenterology, Urology Class 1 876.4730 2006-05-30
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2011-04-05
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2009-11-05
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2018-08-13
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2018-08-13
LWG Surgical Table Cushion General, Plastic Surgery Class 1 878.4950 2010-03-23
GEF Applier, Staple, Surgical, General, Plastic Surgery Class 1 878.4800 2010-08-24
FRN Pump, Infusion General Hospital Class 2 880.5725 2010-07-29
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2009-11-19
BYY Tube, Aspirating, Flexible, Connecting General Hospital Class 2 880.6740 1992-06-27
NOD Board, Arm (With Cover), Non-Sterile General, Plastic Surgery Class 1 878.3910 2013-05-31
CCX Support, Patient Position Anesthesiology Class 1 868.6820 2011-09-09
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2011-05-12
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2011-05-12
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-01-14
KDQ Bottle, Collection, Vacuum General Hospital Class 2 880.6740 1992-06-27
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-08-24
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2021-10-08
OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon General, Plastic Surgery Class 2 878.3300 2025-12-02
OWW Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon General, Plastic Surgery Class 2 878.3300 2025-12-02
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2010-03-10
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2017-05-01
LQR Dislodger, Stone, Biliary Gastroenterology, Urology Class 2 876.5010 2017-05-01
KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) Obstetrics/Gynecology Class 2 884.4160 2009-11-05
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2006-11-13
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
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2012-01-31
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2010-05-20
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2010-06-07
OCY Endoscopic Guidewire, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2016-03-02
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2014-01-24
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2011-02-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2010-06-07
HBT Applier, Hemostatic Clip General, Plastic Surgery Class 1 878.4800 2010-02-15
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2015-03-09
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2010-04-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2010-04-08
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2020-07-08
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2011-10-17
HBT Applier, Hemostatic Clip General, Plastic Surgery Class 1 878.4800 2001-01-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2017-09-15
NTN Led Light Source Gastroenterology, Urology Class 2 876.1500 2024-02-29
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2013-11-14
LDR Controller, Infusion, Intravascular, Electronic General Hospital Class 2 880.5725 2011-04-05
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2019-10-07
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 2010-06-17
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
HFG Coagulator, Laparoscopic, Unipolar (And Accessories) Obstetrics/Gynecology Class 2 884.4160 2009-11-06
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2008-03-14
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2010-01-20
LMB Device, Digital Image Storage, Radiological Radiology Class 1 892.2010 2020-07-17
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency Cardiovascular Class 2 870.2910 2010-08-19
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2010-01-20
GFG Bit, Surgical General, Plastic Surgery Class 1 878.4820 2013-10-29
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2013-07-23
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2009-11-16
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2010-08-19
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2016-11-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-10-06
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2015-03-09
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2014-07-10
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2008-04-22
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2022-05-18
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-05-18
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2010-01-21
GCT Light Source, Endoscope, Xenon Arc Gastroenterology, Urology Class 2 876.1500 2011-05-23
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2016-06-06
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-08-07

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
1223925 Conmed Corporation WESTBOROUGH, MA, 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
K904849 Origin Medsystems, Inc. ORIGINEEDLE(TM) 1991-03-29
K193295 Parcus Medical, LLC Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor 2020-01-23
K193606 Conmed Corporation Y-Knot OneStep Anchor 2020-01-22
K984200 R. Thomas Grotz, M.D., Inc. STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE 1999-01-21
K171060 Riverpoint Medical OrthoButton AL 2017-06-02

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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-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-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.

Similar Registrations

Registration Number Establishment Name Location
9610612 AESCULAP AG TUTTLINGEN, DONAU Baden-Wurttemberg, DE
3014611142 TIANJIN UWELL MEDICAL DEVICE MANUFACTURING CO LTD Tianjin, CN
3017210488 VOMA ECZA DEPOSU MEDIKAL URUNLER SAN. TIC. A.S. IZMIR, TR
3012494290 SANICURE BV SCHIPHOL Noord-Holland, NL
1923569 STERIS Corporation Saint Louis, MO, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1320894. Last updated year: 2026. Please use registration number 1320894 when referencing this establishment in official correspondence.
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