ConMed Corporation

FDA Regulatory Profile

Summary

Total Recalls
91 (9 Class I)
510(k) Clearances
83
Inspections
15
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-2471-2026Class IIConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. CMay 14, 2026
Z-2465-2026Class IIConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length. Catalog Number: iASB12-May 14, 2026
Z-2474-2026Class IIConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 100mm Length. CaMay 14, 2026
Z-2469-2026Class IIConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 75mm Length. CaMay 14, 2026
Z-2472-2026Class IIConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 150mm Length. CaMay 14, 2026
Z-2464-2026Class IIConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip, 150mm Length. Catalog Number: iMay 14, 2026
Z-2467-2026Class IIConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. CMay 14, 2026
Z-2473-2026Class IIConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. May 14, 2026
Z-2470-2026Class IIConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. CMay 14, 2026
Z-2468-2026Class IIConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. CMay 14, 2026
Z-2466-2026Class IIConMed AirSeal 12mm Access Port and Obturator with Blunt Tip, 100mm Length. Catalog Number: iASB12-1May 14, 2026
Z-0474-2023Class IIFoot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, CatalogNovember 18, 2022
Z-1498-2021Class IIINFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibial Elbow and Tip Guides March 26, 2021
Z-1499-2021Class IIKIT_INFINITY_BASE Custom Procedural Kit - Italy, containing Infinity ACL Tibial Elbow and Tip GuidesMarch 26, 2021
Z-0650-2021Class IIInfinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligamNovember 12, 2020
Z-0651-2021Class IIInfinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic procedures for knee ligamNovember 12, 2020
Z-1304-2019Class IIConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX) Catalog Number: TRS100SB2 The AnchoMarch 21, 2019
Z-1309-2019Class IIConMed Anchor Tissue Retrieval System", 12 MM, 300 ML (5/BX) Catalog Number: TRS-ROBO-12 The AnMarch 21, 2019
Z-1308-2019Class IIConMed Anchor Tissue Retrieval System, 8 MM, 125 ML (5/BX) Catalog Number:TRS-ROBO-8 The AnchorMarch 21, 2019
Z-1306-2019Class IIConMed Anchor Tissue Retrieval System, 15 MM, 1850 ML (3/BX) Catalog Number:TRS190SB2 The AnchoMarch 21, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K261363Y-Knotless™ Flex AnchorsMay 13, 2026
K253763Y-Knotless™ Flex AnchorsJanuary 29, 2026
K252946BioBrace® Extra-Articular Ligament Augmentation KitOctober 15, 2025
K251530CONMED Argo Knotless® AnchorJune 18, 2025
K250395BioBrace ® RC Delivery SystemApril 7, 2025
K244025Argo Knotless GENESYS AnchorJanuary 28, 2025
K242187BioBrace®November 27, 2024
K240127PlumeSafe X5 Smoke Management SystemAugust 5, 2024
K241906BioBrace® Reinforced ImplantJuly 29, 2024
K240090Argo Knotless GENESYS AnchorMarch 5, 2024
K231732CleanSeal Advanced Bipolar Vessel Sealer MarylandOctober 23, 2023
K230239AirSeal iFS System; AirSeal dV SolutionSeptember 20, 2023
K230547PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PluApril 27, 2023
K214058Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO WiredAugust 26, 2022
K221945Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE July 28, 2022
K220757Argo Knotless SP AnchorMay 13, 2022
K220186Zone Specific AIMMay 13, 2022
K213354Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, UnifyMarch 11, 2022
K211104AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube SetAugust 19, 2021
K202303CORE E3 Suction/irrigatorFebruary 19, 2021