Data / Medical devices / United States / Conmed Corporation
Conmed Corporation: FDA-registered device maker in Utica, NY, United States, 258 510(k) clearances and 1 PMA approval
Conmed Corporation is registered with the FDA (registration 1320894) in Utica, NY, United States. It lists 113 device types. The FDA files 258 510(k) clearances and 1 PMA approval under its listings, the newest dated May 30, 2026. 37 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1320894
- FEI number
- 3001451571
- Address
- 525 French Rd, Utica, NY, United States, 13502
- Owner or operator
- CONMED CORPORATION (1317214)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler
- First device listed
- June 27, 1992
- Registered through
- 2027
- Brand names listed
- 1 Liter Pressure Infusor, 1000 SES, 10K, Linvatec, 3 Liter Pressure Infusor, 4K UHD Monitor, ABC, ABC Flex Probes, ABC Footswitch and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 258.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 30, 2026 | K261154 | CoLink® & CoLag® Non-Sterile Screws | HWC | Substantially Equivalent | In2Bones USA, LLC | accessdata.fda.gov |
| May 13, 2026 | K261363 | Y-Knotless Flex Anchors | MBI | Substantially Equivalent | CONMED Corporation | accessdata.fda.gov |
| January 29, 2026 | K253763 | Y-Knotless Flex Anchors | MBI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| October 15, 2025 | K252946 | BioBrace® Extra-Articular Ligament Augmentation Kit | MAI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| June 18, 2025 | K251530 | CONMED Argo Knotless® Anchor | MBI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| August 5, 2024 | K240127 | PlumeSafe X5 Smoke Management System | FYD | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| July 29, 2024 | K241906 | BioBrace® Reinforced Implant | OWW | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| March 5, 2024 | K240090 | Argo Knotless GENESYS Anchor | MAI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| September 20, 2023 | K230239 | AirSeal iFS System; AirSeal dV Solution | HIF | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| August 26, 2022 | 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 | Conmed Corporation | accessdata.fda.gov |
| July 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, 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 | Conmed Corporation | accessdata.fda.gov |
| May 13, 2022 | K220757 | Argo Knotless SP Anchor | MBI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| May 13, 2022 | K220186 | Zone Specific AIM | GAT | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| March 11, 2022 | K213354 | Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless FootSwitch, Unify Cart | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| August 19, 2021 | K211104 | AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set | HIF | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| April 30, 2021 | K203267 | The BioBrace Implant | OWW | Substantially Equivalent | Biorez, Inc. | accessdata.fda.gov |
| February 19, 2021 | K202303 | CORE E3 Suction/irrigator | GCJ | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| July 8, 2020 | K201593 | Looking Glass 4K Integrated Visualization System | GCJ | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| June 1, 2020 | K200540 | BRAINSTREAM Disposable Deep Cup EEG Electrodes | GXY | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| January 22, 2020 | K193606 | Y-Knot OneStep Anchor | MBI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| July 3, 2019 | K191204 | Infinity Fixation System | MBI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| June 28, 2019 | K190582 | MicroLink All-Suture Button Fixation System (Radiopaque) | HTN | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| June 28, 2019 | K190516 | MicroLink All-Suture Button Fixation System (Radiolucent) | HTN | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| April 17, 2019 | K182998 | Andorate Auxiliary Water Connector | OCX | Substantially Equivalent | Smartdata Suzhou Co., Ltd. | accessdata.fda.gov |
| March 28, 2019 | K190303 | AirSeal | HIF | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| March 13, 2019 | K183600 | Anchor Bag-Alone Tissue Retrieval System by ConMed | GCJ | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| January 8, 2019 | K182439 | TruShot with Y-Knot Shallow All-Suture Anchor | MBI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| January 4, 2019 | K182621 | CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver | MBI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| December 19, 2018 | K182446 | TruShot with Y-Knot All-Suture Anchor | MBI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| November 14, 2018 | K182882 | CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control | HRX | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| September 11, 2018 | K173822 | Anchor Tissue Retrieval System by CONMED | GCJ | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| July 19, 2018 | K180763 | CuffLink Implant System Biocomposite | MAI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| July 6, 2018 | K181509 | Endorate Valve Sets | OCX | Substantially Equivalent | Smartdata Suzhou Co., Ltd. | accessdata.fda.gov |
| October 18, 2017 | K172940 | ANCHOR Tissue Retrieval System | GCJ | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| October 4, 2017 | K172671 | HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| September 8, 2017 | K171725 | CuffLink Implant System | MBI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| May 18, 2017 | K171139 | LaparoLight Veress Needle | HIF | Substantially Equivalent | Buffalo Filter, LLC | accessdata.fda.gov |
| June 2, 2016 | K151229 | ABC D-FLEX PROBE | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| May 9, 2016 | K161017 | True HD 3MOS Camera System | GCJ | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| December 29, 2015 | K152860 | HELIXAR ELECTROSURGICAL GENERATOR WITH ARGON BEAM COAGULATION, HELIXAR MOBILE PEDESTAL | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| December 18, 2015 | 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 | Conmed Corporation | accessdata.fda.gov |
| June 10, 2015 | K150569 | LaparoVue | GCJ | Substantially Equivalent | Buffalo Filter, LLC | accessdata.fda.gov |
| April 23, 2015 | K142535 | ConMed Mixing and Delivery Kit | FMF | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| March 20, 2015 | K143404 | SurgiQuest AirSeal iFS System | HIF | Substantially Equivalent | Surgiquest, Inc. | accessdata.fda.gov |
| March 5, 2015 | K142464 | Entriport | GCJ | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| February 10, 2015 | K142716 | VCARE | LKF | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| July 23, 2014 | K140578 | ARTHROSCOPIC ENERGY SYSTEM | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| July 11, 2014 | K140459 | ALTRUS THERMAL TISSUE FUSION ENERGY SOURCE, ALTRUS THERMAL TISSUE FUSION HANDPIECE, ALTRUS THERMAL TISSUE FUSION SYSTEM | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| July 10, 2014 | K140658 | THERMOGARD DISPERSIVE ELECTRODES, THERMOGARD PLUS ABC DISPERSIVE ELECTRODES | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| July 10, 2014 | K140101 | ABMEDICA REUSABLE LAPAROSCOPIC HAND INSTRUMENTS AND TROCARS | GCJ | Substantially Equivalent | Ab Medica Sas | accessdata.fda.gov |
| March 28, 2014 | K133116 | VIDEO EXTENDED LENGTH TRAY (PLASTIC - RADEL), VIDEO TRAY SINGLE LEVEL (PLASTIC - RADEL), VIDEO ARTHROSCOPE TRAY (PLASTIC | KCT | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| March 3, 2014 | K131402 | VISICLEAR SMOKE EVACUATION SYSTEM | FYD | Substantially Equivalent | Buffalo Filter Co., Inc. | accessdata.fda.gov |
| December 20, 2013 | K131765 | ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM | DSB | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| December 9, 2013 | K132783 | EXOSHAPE DUO SOFT TISSUE FASTENER | MBI | Substantially Equivalent | MedShape, Inc. | accessdata.fda.gov |
| August 7, 2013 | K131642 | RSH BILIARY STONE REMOVAL DEVICE | LQR | Substantially Equivalent | Rsh, LLC | accessdata.fda.gov |
| February 21, 2013 | K123175 | DETACHATIP III PLUS INSTRUMENT TRAY MODEL 3-4343 | KCT | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| January 3, 2013 | K123439 | NEO ERCP GUIDEWIRE | OCY | Substantially Equivalent | Neometrics, Inc. | accessdata.fda.gov |
| December 21, 2012 | K123260 | DETACHATIP III | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| June 12, 2012 | K120476 | MACROLYTE DISPERSIVE ELECTRODE | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| June 12, 2012 | K120322 | CONMED SUREFIT DUAL DISPERSIVE ELECTRODE | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| May 23, 2012 | K111262 | ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/ ADAPTERS, BIPOLAR ELECTROSURGICAL CABLES, MONOP | GEI | Substantially Equivalent | Olsen Medical | accessdata.fda.gov |
| June 10, 2011 | K111471 | EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE) | MBI | Substantially Equivalent | Medshape Solutions, Inc. | accessdata.fda.gov |
| March 16, 2011 | K103375 | PLUMEPEN INTEGRATED SMOKE EVACUATION PENCIL | GEI | Substantially Equivalent | Medtek Devices, Inc. | accessdata.fda.gov |
| February 16, 2011 | K103665 | CONMED R SABRE GENESIS TM ELECTROSURGICAL UNIT; CONED R SABRE GENESIS TM ELECTROSURGICAL UNIT (230V); CONMED HYFRESURG O | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| November 8, 2010 | K101808 | SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) SOFT TISSUE FASTNER | HWC | Substantially Equivalent | Medshape Solutions | accessdata.fda.gov |
| August 30, 2010 | K101810 | 3DHJD CAMERA SYSTEM MODEL | GCJ | Substantially Equivalent | Vision Systems Group, A Division of Viking Systems | accessdata.fda.gov |
| May 21, 2010 | K100686 | CONMED MACROLYTE DISPERSIVE ELECTRODE | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| March 12, 2010 | K093556 | VCARE DX | LKF | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| March 10, 2010 | K092414 | CONMED DETACHATIP INSTRUMENT TRAY, 33CM AND 43CM | KCT | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| September 23, 2009 | K091930 | ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM, MODEL TRS100SB | GCJ | Substantially Equivalent | Anchor Products Co. | accessdata.fda.gov |
| August 7, 2009 | K091856 | CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES | DRX | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| July 2, 2009 | K090851 | DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R) | ODC | Substantially Equivalent | Byrne Medical, Inc. | accessdata.fda.gov |
| May 5, 2009 | K091139 | CONMED AER DEFENSE SMOKE EVACUATOR | FYD | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| September 10, 2008 | K081644 | BEAMER ARGON PROBE | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| June 25, 2008 | K081634 | CONMED GOLDVAC INTEGRATED SMOKE EVACUATION PENCIL | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| June 19, 2008 | K081580 | BEAMER ARGON SNARE PROBE | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| December 7, 2007 | K073009 | ONEPORT SURGICAL TROCAR SYSTEM | GCJ | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| October 5, 2007 | K071907 | VCARE RETRACTOR/ELEVATOR | LKF | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| August 20, 2007 | K070376 | CONMED LINVATEC 300W XENON LIGHT SOURCE | GCT | Substantially Equivalent | Conmed Linvatec | accessdata.fda.gov |
| January 25, 2007 | K062082 | CONMED ABC DISSECTING BLADE ELECTRODE, MODEL 139330; BLUNT NEEDLE ELECTRODE, MODEL 139331 | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| December 5, 2006 | K063457 | TRUEHD (1080P) DIGITAL CAMERA SYSTEM | GCJ | Substantially Equivalent | Conmed Linvatec | accessdata.fda.gov |
| June 21, 2006 | K061606 | DEFIBRILLATOR CABLE TESTER, MODEL DT2200 | DRG | Substantially Equivalent | Medical Devices/Padpro, Inc. | accessdata.fda.gov |
| April 28, 2006 | K061021 | ENTAKE STANDARD AND SAFETY PEG SYSTEM | KNT | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| February 15, 2006 | K053389 | AESCULAP STERILCONTAINER SYSTEM | FRG | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| September 28, 2005 | K052009 | CONMED SYSTEM MODEL 2450 ELECTROSURGICAL GENERATOR | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| July 14, 2005 | K050992 | CONMED IRRIGATION NOZZLE | KPL | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| April 22, 2005 | K050777 | PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907 | FGE | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| March 24, 2005 | K050163 | HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE | GCJ | Substantially Equivalent | Henke Sass Wolf of America, Inc. | accessdata.fda.gov |
| March 8, 2005 | K050304 | FX WIRE ADVANCED MEASUREMENT GUIDEWIRE | OCY | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| February 3, 2005 | K050161 | SYSTEM 7500-B ELECTROSURGICAL UNIT; ABCFLEX PROBE FOR FLEXIBLE ENDOSCOPY | GEI | Substantially Equivalent | Conmed Electrosurgery | accessdata.fda.gov |
| August 31, 2004 | K032831 | PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 200, ANS-200, AHL-200, NHL-200 | DQA | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| August 9, 2004 | K041953 | VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART | GXY | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| June 15, 2004 | K032327 | MODERN MEDICAL BIPOLAR FORCEPS | GEI | Substantially Equivalent | Modern Medical Equipment Mfg., Ltd. | accessdata.fda.gov |
| May 13, 2004 | K033003 | SUCTION COAGULATOR | GEI | Substantially Equivalent | Modern Medical Equipment Mfg., Ltd. | accessdata.fda.gov |
| January 14, 2004 | K033936 | BARD ELIMINATOR PET BALLOON DILATORS | KNQ | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| May 28, 2002 | K020743 | PADPRO, MODEL 2502 | MKJ | Substantially Equivalent | Padpro, LLC | accessdata.fda.gov |
| May 8, 2002 | K020203 | PADPRO MODEL #2516 | MKJ | Substantially Equivalent | Padpro, LLC | accessdata.fda.gov |
| April 12, 2002 | K020186 | CONMED SYSTEM 5000 ESU | GEI | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| February 27, 2002 | K020288 | PADPRO, MODEL 2603 | MKJ | Substantially Equivalent | Padpro, LLC | accessdata.fda.gov |
| January 18, 2002 | K014209 | PADPRO MODEL 2001, 2001-S, 2001-C, 2001-EPS | MKJ | Substantially Equivalent | Padpro, LLC | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 26, 2021 | P200004 | ConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode Adapters | MKJ | 1 | June 16, 2022 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 14, 2026 | 99498 | Class II | Ongoing | 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. | accessdata.fda.gov |
| May 14, 2026 | 98854 | Class II | Ongoing | 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. | accessdata.fda.gov |
| November 18, 2022 | 91165 | Class II | Terminated | 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. | accessdata.fda.gov |
| March 26, 2021 | 87578 | Class II | Terminated | 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 procedu | 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 | accessdata.fda.gov |
| November 12, 2020 | 86746 | Class II | Terminated | 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 | accessdata.fda.gov |
| February 23, 2018 | 79337 | Class II | Terminated | 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, disposable device fo | Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure | accessdata.fda.gov |
| June 19, 2017 | 79129 | Class II | Terminated | 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 Controller, 12 lengt | Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates. | accessdata.fda.gov |
| April 17, 2017 | 77039 | Class II | Terminated | 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. | Manufactured with the incorrect anchor outer body | accessdata.fda.gov |
| February 28, 2017 | 76482 | Class II | Terminated | 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. There is no problem wi | For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to use a non-sterile sheath as if it were sterile. | accessdata.fda.gov |
| August 29, 2016 | 75056 | Class II | Terminated | 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 shoulder, ankle, wri | CONMED received complaints of damage to the CS-023 electrodes shaft insulation which could result in burn marks on the shaft. If the shaft insulation is damaged in any way, it could increase the risk of patient burn. | accessdata.fda.gov |
| June 27, 2016 | 74774 | Class II | Terminated | 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 laparoscopy, laparoscopic cho | The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product. | accessdata.fda.gov |
| December 21, 2015 | 73123 | Class II | Terminated | 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 HPS-HB12 and 3) PreB | Metal shavings released from burs during use are due to contact between the bur and the hood of the PreBent Bur assembly. During the manufacturing process an assembly error occurred which caused inadvertent mixing of two sizes of bearings. | accessdata.fda.gov |
| November 5, 2015 | 72586 | Class II | Terminated | Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT. Thermal Ligation and Cutting Energy Source. | Miscalibration of the Energy Source monitoring function, which may incorrectly sense the handpiece temperature as higher than the actual handpiece's temperature. This causes some devices to generate a "Check Seal" message with an audible alarm and to stop the heating cycle. | accessdata.fda.gov |
| June 17, 2015 | 71518 | Class II | Terminated | Arthroscopic Energy 50 Probe with Suction, Catalog number: AES-50S Peoduct Usage: For resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic surgical procedures | Probe programming error. The incorrect program can generate more heat at the surgical site, resulting in an elevated probability of tissue damage. | accessdata.fda.gov |
| November 6, 2014 | 69752 | Class I | Terminated | ADULT Radiotransparent Electrode, REF/Catalog Number 2001H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR Intended for use during defibrillation, cardioversion, pacing, and ECG moni | Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death or serious injury. | accessdata.fda.gov |
| May 8, 2014 | 68193 | Class II | Terminated | MACROLYTE Premie Dispersive Electrode, REF, CONMED CORPORATION. The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator. | ConMed Corporation has received complaints regarding sparking, no output and burning at the cord set connection. The complaints have been confirmed by ConMed. | accessdata.fda.gov |
| February 20, 2014 | 67610 | Class II | Terminated | Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1) 10mm x 16 cm Catalog Number: 60-9510-001, 2) 10 mm x 23 cm Catalog Number: 60-9511-001, 3) 10 mm x 36 cm Catalog Number: 60-9512-001, 4) 5 mm | ConMed Corporation initiated an Urgent Medical Device Correction for Altrus Thermal Tissue Fusion Handpieces due to risk of burns. | accessdata.fda.gov |
| October 23, 2013 | 66547 | Class II | Terminated | ALTRUS THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 16 cm Shaft, REF 60-9520-001, STERILE -- CONMED CORPORATION 525 FRENCH RD, UTICA, NY 13502 --- The ConMed Altrus Thermal Tissue Fusion System is comprised | The affected lots were exposed to a higher than acceptable level of particulate matter during manufacture and subsequently distributed. ConMed evaluated the potential risk that this issue could present to the patient and concluded the risk of injury to be negligible; however exposure could cause a minor, local, self correcting infection. | accessdata.fda.gov |
| May 3, 2013 | 65112 | Class II | Terminated | PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. The PadPro(R) Adult Radiotransparent Multifunction Electrodes with Carbon Leadwires and Medtronic(R) Connector are intended to be used i | ConMed was notified by the contract manufacturer that their wire/connector supplier reported damage to the connector tooling which could pinch or compress the lead wire filaments and potentially render the device incapable of delivering the appropriate energy or shock to the patient and/or could cause potential injury to user or patient. | accessdata.fda.gov |
| January 28, 2013 | 64248 | Class II | Terminated | ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION USA. Intended to be used as active RF electrodes for desiccation, fulgura | Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. | accessdata.fda.gov |
| December 27, 2012 | 63981 | Class II | Terminated | ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - SHARP, Disposable Hyfrecator(R) Tips, REF/Catalog No. 7-100-8CS, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories. | ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to us | accessdata.fda.gov |
| November 20, 2012 | 63728 | Class II | Terminated | WANG Transbronchial Aspiration Needles Cat. No. MW-222, WANG Cytology Needles, Central or Peripheral Regions, 22 g x 13 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG T | ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration Needles would not insert properly through the instrument channel of a 2.0 mm bronchoscope. If the device will not fit through the instrument channel of a 2.0 mm bronchoscope, it must be replaced with an alternate device and could result in minor inconvenience to | accessdata.fda.gov |
| April 15, 2011 | 60703 | Not yet classified | Terminated | STAT 2 Pumpette I.V. Compensating Controller, Catalog/REF No. PS2, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- This is a disposable device with a sterile, nonpyrogenic fluid path. Produc | ConMed received 16 complaints for STAT 2 Pumpette devices for inaccurate flow rates and for leakage from the body of the compensating controller. The investigation of the complaints determined that the STAT 2 Pumpette Compensating Controller on several complaint samples had been assembled incorrectly. | accessdata.fda.gov |
| April 15, 2011 | 60702 | Not yet classified | Terminated | STAT 2 I.V. Controller, Catalog/REF No. S2, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- This is a disposable device with a sterile, nonpyrogenic fluid path. For controlling the infusion | ConMed received complaints of some units exhibiting inaccurate or inconsistent flow rates. It was determined that certain units were assembled with an incorrect component which could result in the devices exhibiting a different flow rate and might reduce the ability of the user to regulate the device at low flow rates. | accessdata.fda.gov |
| March 31, 2011 | 60701 | Not yet classified | Terminated | R2 Adult R2 Non-Radiolucent Multifunction Electrodes, Catalog/REF No. 3200-1715, NON-STERILE, MADE IN USA, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13507 This device, when connected to a monitor/defibrillator has t | The specific lot was assembled without the rivet cover. | accessdata.fda.gov |
| March 9, 2011 | 60700 | Not yet classified | Terminated | R2 Adult Zoll Non-Radiolucent Multifunction Electrodes, Catalog/REF 3111-1721, NON-STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13505. This device, when connected to a monitor/defibrillato | The product lot was assembled with an R2 Connector, rather than a Zoll Connector. | accessdata.fda.gov |
| February 2, 2011 | 57841 | Not yet classified | Terminated | VCare Vaginal-Cervical Ahluwalia's Retractor-Elevator devices. The VCare IFU is packaged one per carton of eight VCare Pouched Devices. The Instructions for Use is an 8.5" x 12" 12-page booklet and is packed loose in the | Product manufactured after 4/11/2008, but before 8/01/2009, contains the earlier Instructions For Use, IFU (PN 17416, Rev. D) which does not contain the revisions on the addition of Warning Notes 10 and 11 and the expansion of Warning Note 6 to the VCare Instructions for Use. The reason for the field correction is to provide a copy of the revised IFU to all | accessdata.fda.gov |
| September 23, 2010 | 57827 | Not yet classified | Terminated | Neotrode Wire Attached, Catalog Number: 1731-003; Neotrode II Wire Attached, Catalog Number: 1741-003; Softrace Neonatal Wire Attached, Catalog Number: 2321-003; Softrace Pediatric Wire Attached, Catalog Number: 2331-003 | Poor signal or loss of signal. Certain recalled devices have a loose wire attachment that may lead to intermittent or poor signal quality. | accessdata.fda.gov |
| September 8, 2008 | 49406 | Not yet classified | Terminated | VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) STANDARD, Uterine Manipulator, REF 60-6085-000. Made in USA, CONMED CORPORATION, UTICA, NEW YORK USA 13502. The ConMed VCARE Retractor/Elevator is indicated for man | The firm received several complaints sighting detachment of the balloon at the distal end of the shaft. It was also noted that the incidence of the forward cup slipping off the shaft and being retained in the vaginal canal had increased. | accessdata.fda.gov |
| September 12, 2007 | 45862 | Not yet classified | Terminated | FRAZIER Surgical Suction Instrument, 3 French with Control and Obturator, Product Code: 0031030, 50/C. STERILE, EO, Rx ONLY. MANUFACTURED FOR CONMED CORPORATION, 310 Broad Street, Utica, NY 13501 | Sterility (package integrity) compromised -- Frazier and Poole suction instruments may have an inadequate seal. The product pouch seal made during assembly of this product, may be incomplete or not present. | accessdata.fda.gov |
| March 8, 2007 | 37495 | Not yet classified | Terminated | PADPRO ADULT Radiotranslucent Pad w/Zoll connector. Defibrillation/Pacing/Cardioversion/Monitoring Electrodes, REF/Catalog # 2516Z. RX ONLY. Made in USA for: CONMED CORPORATION Utica, New York, 13502. | Firm was notified of three incidents over the past 15 months in which customers opened the pouch & found an incorrect connector. This error makes the product unusable. The Zoll and Medtronic connectors are not interchangeable and are unique to their specific device. | accessdata.fda.gov |
| November 10, 2006 | 37346 | Not yet classified | Terminated | FRAZIER Surgical Suction Instrument, 3 Fr. with Control Vent and Obturator, REF 0031030. MANUFACTURED FOR CONMED CORPORATION 310 Broad Street, Utica, NY 13501. ASSEMBLED IN MEXICO. | Firm was made aware of instances where the sterile barrier of the instruments had been compromised. | accessdata.fda.gov |
| October 12, 2006 | 36515 | Not yet classified | Terminated | ConMed DetachaTip Laparoscopic Instrument: Allis Multiple Use Grasper, 5mm x 33cm length, REF/Product Code 1-1019. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that perta | The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | accessdata.fda.gov |
| March 27, 2006 | 35949 | Not yet classified | Terminated | ConMed DetachaTip Multi-Use Laparoscopic Instrument - "Fenestrated (Duckbill) Multiple Use Grasper", 5 mm x 33 cm, REF/Product code-1-1008. ------- The product is distributed sterile in heat-sealed tray and labeled with | Grasper jaws breaking at the junction of the jaw and tube during laparoscopic procedures. | accessdata.fda.gov |
| August 9, 2004 | 29821 | Not yet classified | Terminated | ConMed Stealth Coated Laparoscopic Electrodes with 3/32'' pin (60-5158 series) as follows: Cat. #60-5158-027 - Spatula 5 mm x 27 cm; Cat #60-5158-032 - Spatula 5 mm x 32 cm; Cat. #60-5158-044 - Spatula 5 mm x 44 cm; Cat | Insulation may pull away from the hub of the electrode exposing the conductive shaft below. This condition results in potential for electrical shock. | accessdata.fda.gov |
| June 28, 2004 | 29478 | Not yet classified | Terminated | ConMed Stealth coated Laparoscopic Electrodes with 4mm Pin (60-5158 series). Cat. #60-5158-034 - Spatula; Cat. #60-5158-234 -''J'' Hook; Cat. #60-5158-432 - ''L'' Hook; Cat. # 60-5158-934 - Needle. FIRM ON LABEL: ConMed | Insulation of some electrodes may have pulled away from the hub of the electrode exposing the conductive shaft below. There is potential for electrical shock. | accessdata.fda.gov |
| July 30, 2003 | 26988 | Not yet classified | Terminated | 1680 Invisatrace series ECG Electrodes, radiotranslucent clear tape ECG electrode with wet gel. This is a single use, disposable device. Electrodes are packaged and sold as: Cat No 1680-001 (1 unit per pouch/30 per box); | Separation of the sensing element from the body of the electrode. | accessdata.fda.gov |
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Updated August 26, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.