ConMed Corporation

FDA Regulatory Profile

Summary

Total Recalls
80 (9 Class I)
510(k) Clearances
82
Inspections
14
Compliance Actions
1

Recent Recalls

NumberClassProductDate
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-1307-2019Class IIConMed Anchor Tissue Retrieval System, VATS, 15 MM, 1550 ML (3/BX) Catalog Number: TRS-VATS-15 March 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-1306-2019Class IIConMed Anchor Tissue Retrieval System, 15 MM, 1850 ML (3/BX) Catalog Number:TRS190SB2 The AnchoMarch 21, 2019
Z-1305-2019Class IIConMed Anchor Tissue Retrieval System 15 MM, 1550 ML (3/BX) Catalog Number: TRS175SB2 The AnchoMarch 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-1304-2019Class IIConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX) Catalog Number: TRS100SB2 The AnchoMarch 21, 2019
Z-1177-2018Class IIMINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Connector, REF/Catalog NuFebruary 23, 2018
Z-1174-2018Class IIMINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602February 23, 2018
Z-1176-2018Class IIMINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602February 23, 2018
Z-1175-2018Class IIMINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602February 23, 2018
Z-1178-2018Class IIMINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL¿ Connector, REF/Catalog Number 2602Z IndicatFebruary 23, 2018
Z-0804-2018Class IISTAT 2¿ I.V. Gravity Flow Controller and STAT 2¿ Primary, Secondary Administration Sets and ExtensioJune 19, 2017
Z-0805-2018Class IISTAT 2¿ I.V. Gravity Flow Needle-Free Controller Primary Administration Sets and Extension Sets (CatJune 19, 2017
Z-0253-2018Class IINonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical pApril 17, 2017
Z-1757-2017Class IISterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECAFebruary 28, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
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
K220186Zone Specific AIMMay 13, 2022
K220757Argo Knotless SP AnchorMay 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
K201593Looking Glass 4K Integrated Visualization SystemJuly 8, 2020