ConMed Corporation
Westborough, MA, US
ConMed Corporation appears in FDA device records in Westborough, MA. FDA records list 84 510(k) clearances between and , 2 PMA records and 5 registered establishments. As of , FDA records show 213 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to ConMed Corporation carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Conmed Electrosurgery510(k), recall
- Vision Systems Group, A Div of Viking Systemsrecall
510(k) clearance history
Showing 50 of 84FDA records hold 84 510(k) clearances for ConMed Corporation between 2004 and 2026. The busiest year on record is 2019, with 9. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 2 |
| 2005 | 3 |
| 2006 | 1 |
| 2007 | 3 |
| 2008 | 3 |
| 2009 | 3 |
| 2010 | 4 |
| 2011 | 1 |
| 2012 | 3 |
| 2013 | 2 |
| 2014 | 5 |
| 2015 | 7 |
| 2016 | 3 |
| 2017 | 6 |
| 2018 | 6 |
| 2019 | 9 |
| 2020 | 3 |
| 2021 | 2 |
| 2022 | 5 |
| 2023 | 3 |
| 2024 | 4 |
| 2025 | 4 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261363 | Y-Knotless™ Flex Anchors | MBI | Substantially Equivalent | |
| K253763 | Y-Knotless™ Flex Anchors | MBI | Substantially Equivalent | |
| K252946 | BioBrace® Extra-Articular Ligament Augmentation Kit | MAI | Substantially Equivalent | |
| K251530 | CONMED Argo Knotless® Anchor | MBI | Substantially Equivalent | |
| K250395 | BioBrace ® RC Delivery System | ORQ | Substantially Equivalent | |
| K244025 | Argo Knotless GENESYS Anchor | MBI | Substantially Equivalent | |
| K242187 | BioBrace® | OWW | Substantially Equivalent | |
| K240127 | PlumeSafe X5 Smoke Management System | FYD | Substantially Equivalent | |
| K241906 | BioBrace® Reinforced Implant | OWW | Substantially Equivalent | |
| K240090 | Argo Knotless GENESYS Anchor | MAI | Substantially Equivalent | |
| K231732 | CleanSeal Advanced Bipolar Vessel Sealer Maryland | GEI | Substantially Equivalent | |
| K230239 | AirSeal iFS System; AirSeal dV Solution | HIF | Substantially Equivalent | |
| K230547 | PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter | GEI | Substantially Equivalent | |
| K214058 | Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure Reducer | GEI | Substantially Equivalent | |
| K221945 | Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8 mm X 320 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm X 230 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm x 320 cm, Beamer AVEO FILTER INTEGRATED ARGON SIDEFIRE PROBE 2.3 mm x 230 cm | GEI | Substantially Equivalent | |
| K220757 | Argo Knotless SP Anchor | MBI | Substantially Equivalent | |
| K220186 | Zone Specific AIM | GAT | Substantially Equivalent | |
| K213354 | Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless FootSwitch, Unify Cart | GEI | Substantially Equivalent | |
| K211104 | AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set | HIF | Substantially Equivalent | |
| K202303 | CORE E3 Suction/irrigator | GCJ | Substantially Equivalent | |
| K201593 | Looking Glass 4K Integrated Visualization System | GCJ | Substantially Equivalent | |
| K200540 | BRAINSTREAM Disposable Deep Cup EEG Electrodes | GXY | Substantially Equivalent | |
| K193606 | Y-Knot OneStep Anchor | MBI | Substantially Equivalent | |
| K191204 | Infinity Fixation System | MBI | Substantially Equivalent | |
| K190582 | MicroLink All-Suture Button Fixation System (Radiopaque) | HTN | Substantially Equivalent | |
| K190516 | MicroLink All-Suture Button Fixation System (Radiolucent) | HTN | Substantially Equivalent | |
| K190303 | AirSeal | HIF | Substantially Equivalent | |
| K190333 | Paradigm All-Suture Anchor 1.8mm, White/Black #2 | MBI | Substantially Equivalent | |
| K183600 | Anchor Bag-Alone Tissue Retrieval System by ConMed | GCJ | Substantially Equivalent | |
| K182955 | EZStart Interference Screw | HWC | Substantially Equivalent | |
| K182439 | TruShot with Y-Knot Shallow All-Suture Anchor | MBI | Substantially Equivalent | |
| K182621 | CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver | MBI | Substantially Equivalent | |
| K181120 | 2.8 mm/3.3 mm PopLok Suture Anchors | MBI | Substantially Equivalent | |
| K182446 | TruShot with Y-Knot All-Suture Anchor | MBI | Substantially Equivalent | |
| K182882 | CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control | HRX | Substantially Equivalent | |
| K173822 | Anchor Tissue Retrieval System by CONMED | GCJ | Substantially Equivalent | |
| K180763 | CuffLink Implant System Biocomposite | MAI | Substantially Equivalent | |
| K172516 | SurgiQuest AIRSEAL iFS System | HIF | Substantially Equivalent | |
| K172940 | ANCHOR Tissue Retrieval System | GCJ | Substantially Equivalent | |
| K172671 | HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal | GEI | Substantially Equivalent | |
| K171725 | CuffLink Implant System | MBI | Substantially Equivalent | |
| K171592 | CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver | MAI | Substantially Equivalent | |
| K170501 | CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver | MAI | Substantially Equivalent | |
| K163258 | CrossFT Knotless Suture Anchor with Disposable Driver | MBI | Substantially Equivalent | |
| K151229 | ABC D-FLEX PROBE | GEI | Substantially Equivalent | |
| K161017 | True HD 3MOS Camera System | GCJ | Substantially Equivalent | |
| K152969 | ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAY | KCT | Substantially Equivalent | |
| K152860 | HELIXAR ELECTROSURGICAL GENERATOR WITH ARGON BEAM COAGULATION, HELIXAR MOBILE PEDESTAL | GEI | Substantially Equivalent | |
| K153499 | EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes, Arthroscopic Energy System Wireless Footswitch, Arthroscopic Energy System Corded Footswitch, Arthroscopic Energy System Foot Control, Extension | GEI | Substantially Equivalent | |
| K150936 | SureClip | FZP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1320894 | 3001451571 | CONMED CORPORATION | 525 French Rd, Utica, NY 13502 US | 2026 | and 102 more, listed in full below |
| 3004491689 | 3004491689 | ConMed Corporation | 6363 S Fiddlers Green Cir Ste 1400, Greenwood Village, CO 80111 US | 2026 | and 25 more, listed in full below |
| 3007216334 | 3007216334 | ConMed Corporation | 1250 Terminus Dr., Lithia Spgs, GA 30122 US | 2026 | No device listings on this registration |
| 3019101334 | 3019101334 | ConMed Corporation | 470 James St Ste 003, New Haven, CT 06513 US | 2026 | |
| 1223925 | 1000305720 | Conmed Corporation | 134 Flanders Rd, WESTBOROUGH, MA 01581 US | 2026 | and 32 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FYDApparatus, Exhaust, Surgical
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- GEFApplier, Staple, Surgical,
- GCABiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
- FCGBiopsy Needle
- GFGBit, Surgical
- EOQBronchoscope (Flexible Or Rigid)
- BTGBrush, Biopsy, Bronchoscope (Non-Rigid)
- GEEBrush, Biopsy, General & Plastic Surgery
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- FXMCamera, Still, Endoscopic
- FBMCannula And Trocar, Suprapubic, Non-Disposable
- FGYCannula, Injection
- GEACannula, Surgical, General & Plastic Surgery
- GBWCatheter, Peritoneal
- FZPClip, Implantable
- FZQClip, Removable (Skin)
- DQKComputer, Diagnostic, Programmable
- DRXElectrode, Electrocardiograph
- FEHElectrode, Flexible Suction Coagulator
- DWGElectrosurgical Device
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- FEDEndoscopic Access Overtube, Gastroenterology-Urology
- FDXEndoscopic Cytology Brush
- GCLEsophagoscope, General & Plastic Surgery
- FCLForceps, Biopsy, Non-Electric
- GENForceps, General & Plastic Surgery
- FXRHolder, Camera, Surgical
- GCJLaparoscope, General & Plastic Surgery
- FHNLigator, Hemorrhoidal
- GCTLight Source, Endoscope, Xenon Arc
- FCWLight Source, Fiberoptic, Routine
- FXXMask, Surgical
- FTLMesh, Surgical, Polymeric
- BZQMonitor, Breathing Frequency
- GETMotor, Surgical Instrument, Pneumatic Powered
- GAANeedle, Aspiration And Injection, Disposable
- FECObturator, For Endoscope
- FWZOperating Room Accessories Table Tray
- DQAOximeter
- DSBPlethysmograph, Impedance
- FHOPneumoperitoneum Needle
- FMPProtector, Skin Pressure
- FRNPump, Infusion
- FPASet, Administration, Intravascular
- FDISnare, Flexible
- FGXSnare, Non-Electrical
- FOXStand, Infusion
- GDTStaple, Removable (Skin)
- FGEStents, Drains And Dilators For The Biliary Ducts
- CCXSupport, Patient Position
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- FMFSyringe, Piston
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
- FSMTray, Surgical, Instrument
- BYYTube, Aspirating, Flexible, Connecting
- GAZTubing, Noninvasive
- BYXTubing, Pressure And Accessories
- FRGWrap, Sterilization
Recall records
Showing 25 of 213| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-3018-2026 | CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5.5mm GENESYs CrossFT Suture Anchor with two, #2 (5 metric) Hi-Fi Sutures Sterile | Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability. | Class II | Open, Classified | |
| Z-2474-2026 | ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS12-100LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy. | Potential for overpressure alerts. | Class II | Open, Classified | |
| Z-2473-2026 | ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS12-120LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy. | Potential for overpressure alerts. | Class II | Open, Classified | |
| Z-2472-2026 | ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 150mm Length. Catalog Number: iAS12-150LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy. | Potential for overpressure alerts. | Class II | Open, Classified | |
| Z-2471-2026 | ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS5-100LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy. | Potential for overpressure alerts. | Class II | Open, Classified | |
| Z-2470-2026 | ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS5-120LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy. | Potential for overpressure alerts. | Class II | Open, Classified | |
| Z-2469-2026 | ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 75mm Length. Catalog Number: iAS5-75LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy. | Potential for overpressure alerts. | Class II | Open, Classified | |
| Z-2468-2026 | ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS8-100LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy. | Potential for overpressure alerts. | Class II | Open, Classified | |
| Z-2467-2026 | ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS8-120LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy. | Potential for overpressure alerts. | Class II | Open, Classified | |
| Z-2466-2026 | ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip, 100mm Length. Catalog Number: iASB12-100. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy. | Potential for overpressure alerts. | Class II | Open, Classified | |
| Z-2465-2026 | ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length. Catalog Number: iASB12-120. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy. | Potential for overpressure alerts. | Class II | Open, Classified | |
| Z-2464-2026 | ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip, 150mm Length. Catalog Number: iASB5-150. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy | Potential for overpressure alerts. | Class II | Open, Classified | |
| Z-0474-2023 | Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number 130187 | Suction ports may potentially be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use, which could cause a delay in procedure and could require another device to be used. | Class II | Terminated | |
| Z-1499-2021 | KIT_INFINITY_BASE Custom Procedural Kit - Italy, containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE100 and KTT100. For use in open and arthroscopic procedures for knee ligament reconstruction The procedural kits have no kit specific labeling. Each product within the kits has its own product specific labeling. | Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system and could cause a delay in procedure and may require another device or alternate surgical method to be used | Class II | Terminated | |
| Z-1498-2021 | INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE100 and KTT100. For use in open and arthroscopic procedures for knee ligament reconstruction. The procedural kits have no kit specific labeling. Each product within the kits has its own product specific labeling. | Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system and could cause a delay in procedure and may require another device or alternate surgical method to be used | Class II | Terminated | |
| Z-0651-2021 | Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTT100 | Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system | Class II | Terminated | |
| Z-0650-2021 | Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTE100 | Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system | Class II | Terminated | |
| Z-1309-2019 | ConMed Anchor Tissue Retrieval System", 12 MM, 300 ML (5/BX) Catalog Number: TRS-ROBO-12 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery. | Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product | Class II | Terminated | |
| Z-1308-2019 | ConMed Anchor Tissue Retrieval System, 8 MM, 125 ML (5/BX) Catalog Number:TRS-ROBO-8 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery. | Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product | Class II | Terminated | |
| Z-1307-2019 | ConMed Anchor Tissue Retrieval System, VATS, 15 MM, 1550 ML (3/BX) Catalog Number: TRS-VATS-15 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery. | Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product | Class II | Terminated | |
| Z-1306-2019 | ConMed Anchor Tissue Retrieval System, 15 MM, 1850 ML (3/BX) Catalog Number:TRS190SB2 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery. | Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product | Class II | Terminated | |
| Z-1305-2019 | ConMed Anchor Tissue Retrieval System 15 MM, 1550 ML (3/BX) Catalog Number: TRS175SB2 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery. | Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product | Class II | Terminated | |
| Z-1304-2019 | ConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX) Catalog Number: TRS100SB2 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery. | Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product | Class II | Terminated | |
| Z-1178-2018 | MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL Connector, REF/Catalog Number 2602Z Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.). | Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure | Class II | Terminated | |
| Z-1177-2018 | MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control Quik-Combo" Connector, REF/Catalog Number 2602M Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.). | Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain