Company · US
Conmed Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2026. Name variants (Inc, Corp, punctuation) are merged.
83510(k) clearances (2 in 12 months)
178recalls (12 in 12 months)
153recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 78 |
| GCJ | Laparoscope, General & Plastic Surgery | 55 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 17 |
| HIF | Insufflator, Laparoscopic | 15 |
| FPA | Set, Administration, Intravascular | 13 |
| MKJ | Automated External Defibrillators (Non-Wearable) | 13 |
| GBW | Catheter, Peritoneal | 6 |
| LFK | Catheter, Femoral | 6 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 6 |
| DRX | Electrode, Electrocardiograph | 4 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 4 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 4 |
| LDR | Controller, Infusion, Intravascular, Electronic | 4 |
| LXH | Orthopedic Manual Surgical Instrument | 4 |
| DQA | Oximeter | 3 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 3 |
| LKF | Cannula, Manipulator/Injector, Uterine | 3 |
| MLN | Electrode, Electrocardiograph, Multi-Function | 3 |
| FYD | Apparatus, Exhaust, Surgical | 2 |
| HTN | Washer, Bolt Nut | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 13, 2026 | K261363 | Y-Knotless Flex Anchors CONMED Corporation | MBI |
| Jan 29, 2026 | K253763 | Y-Knotless Flex Anchors Conmed Corporation | MBI |
| Oct 15, 2025 | K252946 | BioBrace® Extra-Articular Ligament Augmentation Kit Conmed Corporation | MAI |
| Jun 18, 2025 | K251530 | CONMED Argo Knotless® Anchor Conmed Corporation | MBI |
| Apr 7, 2025 | K250395 | BioBrace ® RC Delivery System Conmed Corporation | ORQ |
| Jan 28, 2025 | K244025 | Argo Knotless GENESYS Anchor Conmed Corporation | MBI |
| Nov 27, 2024 | K242187 | BioBrace® Conmed Corporation | OWW |
| Aug 5, 2024 | K240127 | PlumeSafe X5 Smoke Management System Conmed Corporation | FYD |
| Jul 29, 2024 | K241906 | BioBrace® Reinforced Implant Conmed Corporation | OWW |
| Mar 5, 2024 | K240090 | Argo Knotless GENESYS Anchor Conmed Corporation | MAI |
| Oct 23, 2023 | K231732 | CleanSeal Advanced Bipolar Vessel Sealer Maryland Conmed Corporation | GEI |
| Sep 20, 2023 | K230239 | AirSeal iFS System; AirSeal dV Solution Conmed Corporation | HIF |
| Apr 27, 2023 | K230547 | PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Conmed Corporation | GEI |
| Aug 26, 2022 | K214058 | Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer Conmed Corporation | GEI |
| Jul 28, 2022 | K221945 | Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8 mm X 320 cm, Bea Conmed Corporation | GEI |
| May 13, 2022 | K220757 | Argo Knotless SP Anchor Conmed Corporation | MBI |
| May 13, 2022 | K220186 | Zone Specific AIM Conmed Corporation | GAT |
| Mar 11, 2022 | K213354 | Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless FootSwitch Conmed Corporation | GEI |
| Aug 19, 2021 | K211104 | AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set Conmed Corporation | HIF |
| Feb 19, 2021 | K202303 | CORE E3 Suction/irrigator Conmed Corporation | GCJ |
| Jul 8, 2020 | K201593 | Looking Glass 4K Integrated Visualization System Conmed Corporation | GCJ |
| Jun 1, 2020 | K200540 | BRAINSTREAM Disposable Deep Cup EEG Electrodes Conmed Corporation | GXY |
| Jan 22, 2020 | K193606 | Y-Knot OneStep Anchor Conmed Corporation | MBI |
| Jul 3, 2019 | K191204 | Infinity Fixation System Conmed Corporation | MBI |
| Jun 28, 2019 | K190582 | MicroLink All-Suture Button Fixation System (Radiopaque) Conmed Corporation | HTN |
| Jun 28, 2019 | K190516 | MicroLink All-Suture Button Fixation System (Radiolucent) Conmed Corporation | HTN |
| Mar 28, 2019 | K190303 | AirSeal Conmed Corporation | HIF |
| Mar 18, 2019 | K190333 | Paradigm All-Suture Anchor 1.8mm, White/Black #2 Conmed Corporation | MBI |
| Mar 13, 2019 | K183600 | Anchor Bag-Alone Tissue Retrieval System by ConMed Conmed Corporation | GCJ |
| Jan 22, 2019 | K182955 | EZStart Interference Screw Conmed Corporation | HWC |
| Jan 8, 2019 | K182439 | TruShot with Y-Knot Shallow All-Suture Anchor Conmed Corporation | MBI |
| Jan 4, 2019 | K182621 | CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver Conmed Corporation | MBI |
| Dec 21, 2018 | K181120 | 2.8 mm/3.3 mm PopLok Suture Anchors Conmed Corporation | MBI |
| Dec 19, 2018 | K182446 | TruShot with Y-Knot All-Suture Anchor Conmed Corporation | MBI |
| Nov 14, 2018 | K182882 | CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control Conmed Corporation | HRX |
| Sep 11, 2018 | K173822 | Anchor Tissue Retrieval System by CONMED Conmed Corporation | GCJ |
| Jul 19, 2018 | K180763 | CuffLink Implant System Biocomposite Conmed Corporation | MAI |
| Mar 16, 2018 | K172516 | SurgiQuest AIRSEAL iFS System Conmed Corporation | HIF |
| Oct 18, 2017 | K172940 | ANCHOR Tissue Retrieval System Conmed Corporation | GCJ |
| Oct 4, 2017 | K172671 | HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal Conmed Corporation | GEI |
| Sep 8, 2017 | K171725 | CuffLink Implant System Conmed Corporation | MBI |
| Aug 29, 2017 | K171592 | CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver Conmed Corporation | MAI |
| Mar 17, 2017 | K170501 | CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver Conmed Corporation | MAI |
| Jan 25, 2017 | K163258 | CrossFT Knotless Suture Anchor with Disposable Driver Conmed Corporation | MBI |
| Jun 2, 2016 | K151229 | ABC D-FLEX PROBE Conmed Corporation | GEI |
| May 9, 2016 | K161017 | True HD 3MOS Camera System Conmed Corporation | GCJ |
| Mar 31, 2016 | K152969 | ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAY Conmed Corporation | KCT |
| Dec 29, 2015 | K152860 | HELIXAR ELECTROSURGICAL GENERATOR WITH ARGON BEAM COAGULATION, HELIXAR MOBILE PEDESTAL Conmed Corporation | GEI |
| Dec 18, 2015 | K153499 | EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes, Arthroscopic Energy System Wireless Footswitch, Arth Conmed Corporation | GEI |
| Oct 23, 2015 | K150936 | SureClip Conmed Corporation | FZP |
Newest 50 of 83.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2026 | ConMed Corporation 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 Open, Classified |
MAI | K101100 |
| Jun 17, 2026 | ConMed Corporation 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 Dioxi Open, Classified |
HIF | K143404 |
| Jun 17, 2026 | ConMed Corporation 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 Dio Open, Classified |
HIF | K143404 |
| Jun 17, 2026 | ConMed Corporation 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 Dioxi Open, Classified |
HIF | K143404 |
| Jun 17, 2026 | ConMed Corporation 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 Dioxid Open, Classified |
HIF | K143404 |
| Jun 17, 2026 | ConMed Corporation 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 Dioxid Open, Classified |
HIF | K143404 |
| Jun 17, 2026 | ConMed Corporation 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 Open, Classified |
HIF | K143404 |
| Jun 17, 2026 | ConMed Corporation 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 Dioxid Open, Classified |
HIF | K143404 |
| Jun 17, 2026 | ConMed Corporation 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 Dioxid Open, Classified |
HIF | K143404 |
| Jun 17, 2026 | ConMed Corporation 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 Lapar Open, Classified |
HIF | K143404 |
| Jun 17, 2026 | ConMed Corporation 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 Lapa Open, Classified |
HIF | K143404 |
| Jun 17, 2026 | ConMed Corporation 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 Open, Classified |
HIF | K143404 |
| Dec 9, 2022 | ConMed Corporation Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number 130187 Terminated |
GEI | K033003 |
| Mar 26, 2021 | ConMed Corporation 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 rec Terminated |
LXH | None listed |
| Mar 26, 2021 | ConMed Corporation 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 recons Terminated |
LXH | None listed |
| Nov 12, 2020 | ConMed Corporation Infinity ACL Tibial Tip Guide-
indicated for use in open and arthroscopic procedures for knee ligament reconstruction.
Catalog Number: KTT100 Terminated |
LXH | None listed |
| Nov 12, 2020 | ConMed Corporation Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction.
Catalog Number: KTE100 Terminated |
LXH | None listed |
| Mar 21, 2019 | Conmed Corporation 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 Terminated |
GCJ | K172940 |
| Mar 21, 2019 | Conmed Corporation 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 Terminated |
GCJ | K172940 |
| Mar 21, 2019 | Conmed Corporation 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 intro Terminated |
GCJ | K172940 |
| Mar 21, 2019 | Conmed Corporation 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 Terminated |
GCJ | K172940 |
| Mar 21, 2019 | Conmed Corporation 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 Terminated |
GCJ | K172940 |
| Mar 21, 2019 | Conmed Corporation 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 Terminated |
GCJ | K172940 |
| Feb 23, 2018 | ConMed Corporation 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 Terminated |
MKJ | K002280 |
| Feb 23, 2018 | ConMed Corporation 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 no Terminated |
MKJ | K002280 |
| Feb 23, 2018 | ConMed Corporation MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H
Indicated for use in external pacing, defibrillation and monitoring applications as a non-steril Terminated |
MKJ | K002280 |
| Feb 23, 2018 | ConMed Corporation MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H
Indicated for use in external pacing, defibrillation and monitoring applications as a non-steril Terminated |
MKJ | K002280 |
| Feb 23, 2018 | ConMed Corporation MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602
Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, Terminated |
MKJ | K002280 |
| Jun 19, 2017 | ConMed Corporation STAT 2 I.V. Gravity Flow Needle-Free Controller Primary Administration Sets and Extension Sets (Catalog Numbers: (1) S2-12 N, STAT 2 Extension Set Gravity Flow Controller (Needle-Free), 12 length, (2) Terminated |
FPA | K964844 |
| Jun 19, 2017 | ConMed Corporation STAT 2 I.V. Gravity Flow Controller and STAT 2 Primary, Secondary Administration Sets and Extension Sets (Catalog Numbers: (1) S2, STAT 2 I.V. Controller, (2) S2-12, STAT 2 Extension Set Gravity Flow Terminated |
LDR | K905498 |
| Apr 17, 2017 | ConMed Corporation Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures may be used in either arthroscopic or open surgical procedures. Terminated |
MBI | K091549 |
| Feb 28, 2017 | ConMed Corporation HYFRECATOR 2000 HANDPIECE SHEATH, REF/Part Number 7-796-19, Rx ONLY, STERILE, Single Patient Use -- CONMED CORPORATION, 525 FRENCH ROAD UTICA, NY 13502. --- There is no problem with the Hyfrecator 200 Terminated |
GEI | K963088 |
| Feb 28, 2017 | ConMed Corporation Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 230 VOLTS AC, REF/Catalog Number 7-900-230, Rx Only. T Terminated |
GEI | K963088 |
| Feb 28, 2017 | ConMed Corporation Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons , 220 VOLTS AC, REF/Catalog Number 7-900-220, Rx Only, Terminated |
GEI | K963088 |
| Feb 28, 2017 | ConMed Corporation Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 115 VOLTS AC, REF/Catalog Number 7-900-115, Rx Only . Terminated |
GEI | K963088 |
| Feb 28, 2017 | ConMed Corporation Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 100 VOLTS AC, REF/Catalog Number 7-900-100, Rx Only. T Terminated |
GEI | K963088 |
| Aug 29, 2016 | ConMed Corporation CONCEPT HEATWAVE Electrode 130 mm x 2.3 mm diameter, REF/Catalog Number CS-023, STERILE, Rx Only
Product Usage:
The HeatWave Electrode is intended to be used for electro-coagulation of soft tissue in Terminated |
JOS | K991830 |
| Jun 27, 2016 | ConMed Corporation CORE Trumpet Handpiece only, Catalog Number CD8450
The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic proc Terminated |
GBW | K926477 |
| Jun 27, 2016 | ConMed Corporation CORE Trumpet Handpiece with 5mm x 32cm Length Probe , Catalog Number CD8400
The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy an Terminated |
GBW | K926477 |
| Jun 27, 2016 | ConMed Corporation CORE Suction Irrigation Handpiece without Probe for Single Solution or Dual Bags, Catalog Number CD8302
The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, lap Terminated |
GBW | K926477 |
| Jun 27, 2016 | ConMed Corporation CORE Suction Irrigation Handpiece without Probe for Single Solution Bags, Catalog Number CD8300
The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopi Terminated |
GBW | K926477 |
| Jun 27, 2016 | ConMed Corporation CORE Suction Irrigation Handpiece Y-Tubing set, with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8200
The CORE Suction/Irrigation Y Tubing Set with Trumpet Valves (CD820 Terminated |
GAZ | K930512 |
| Jun 27, 2016 | ConMed Corporation CORE Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8190
The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological Terminated |
GBW | K926477 |
| Jun 27, 2016 | ConMed Corporation CORE Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution Bags, Catalog Number CD8185
The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparosco Terminated |
GBW | K926477 |
| May 31, 2016 | ConMed Corporation Hip Preservation System Signature Series PreBent Burs under the following labels: 1) PreBent Spherical Bur, 5.5mm x 19cm Catalog Number HPS-HB11, 2) PreBent Polishing Bur, 5.5mm x 19cm Catalog Number Terminated |
GFF | None listed |
| May 18, 2016 | Conmed Corporation Pediatric Dual Dispersive Electrodes (for patients 5-15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 7550 ABC generators or Terminated |
GEI | K140658 |
| May 18, 2016 | Conmed Corporation Adult Dual Dispersive Electrodes (for patients >15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 7550 ABC generators or conv Terminated |
GEI | K140658 |
| May 18, 2016 | Conmed Corporation Pediatric ThermoGard Dual Dispersive Electrodes (for patients 5-15 kg.), 10' (3.05m) Cable, Catalog Number 51-7710.
Intended to be used for the dispersion and return to the electrosurgical generator. Terminated |
GEI | K140658 |
| May 18, 2016 | Conmed Corporation Adult ThermoGard Dual Dispersive Electrodes (for patients >15 kg.), No Cable, Catalog Number 51-7410.
Intended to be used for the dispersion and return to the electrosurgical generator. Terminated |
GEI | K140658 |
| May 18, 2016 | Conmed Corporation Adult ThermoGard Dual Dispersive Electrodes (for patients >15 kg.), 10' (3.05m) Cable, Catalog Number 51-7310.
Intended to be used for the dispersion and return to the electrosurgical generator. Terminated |
GEI | K140658 |
Newest 50 of 178.