Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

CONMED Corporation · Predicate Candidate Screening

83 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

90 daysmedian FDA review time
215 days90th percentile
83clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K261363Y-Knotless™ Flex AnchorsCONMED Corporation2026-05-13160
K253763Y-Knotless™ Flex AnchorsConmed Corporation2026-01-29650
K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation2025-10-15300
K251530CONMED Argo Knotless® AnchorConmed Corporation2025-06-18300
K250395BioBrace ® RC Delivery SystemConmed Corporation2025-04-07540
K244025Argo Knotless GENESYS AnchorConmed Corporation2025-01-28320
K242187BioBrace®Conmed Corporation2024-11-271250
K240127PlumeSafe X5 Smoke Management SystemConmed Corporation2024-08-052010
K241906BioBrace® Reinforced ImplantConmed Corporation2024-07-29280
K240090Argo Knotless GENESYS AnchorConmed Corporation2024-03-05530
K231732CleanSeal Advanced Bipolar Vessel Sealer MarylandConmed Corporation2023-10-231320
K230239AirSeal iFS System; AirSeal dV SolutionConmed Corporation2023-09-202330
K230547PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen PConmed Corporation2023-04-27580
K214058Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon ModConmed Corporation2022-08-262420
K221945Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, BeConmed Corporation2022-07-28230
K220186Zone Specific AIMConmed Corporation2022-05-131090
K220757Argo Knotless SP AnchorConmed Corporation2022-05-13590
K213354Unify Multifunction Energy Platform, CleanSeal Vessel SealerConmed Corporation2022-03-111500
K211104AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® BifuConmed Corporation2021-08-191280
K202303CORE E3 Suction/irrigatorConmed Corporation2021-02-191890
K201593Looking Glass 4K Integrated Visualization SystemConmed Corporation2020-07-08260
K200540BRAINSTREAM Disposable Deep Cup EEG ElectrodesConmed Corporation2020-06-01900
K193606Y-Knot OneStep AnchorConmed Corporation2020-01-22300
K191204Infinity Fixation SystemConmed Corporation2019-07-03580
K190582MicroLink All-Suture Button Fixation System (Radiopaque)Conmed Corporation2019-06-281140
K190516MicroLink All-Suture Button Fixation System (Radiolucent)Conmed Corporation2019-06-281160
K190303AirSealConmed Corporation2019-03-28440
K190333Paradigm All-Suture Anchor 1.8mm, White/Black #2Conmed Corporation2019-03-18320
K183600Anchor Bag-Alone Tissue Retrieval System by ConMedConmed Corporation2019-03-13770
K182955EZStart Interference ScrewConmed Corporation2019-01-22900
K182439TruShot with Y-Knot Shallow All-Suture AnchorConmed Corporation2019-01-081230
K182621CrossFT Knotless Deep Thread Suture Anchor with Disposable DConmed Corporation2019-01-041020
K1811202.8 mm/3.3 mm PopLok Suture AnchorsConmed Corporation2018-12-212380
K182446TruShot with Y-Knot All-Suture AnchorConmed Corporation2018-12-191030
K182882CrystalView Pro Irrigation Console, CrystalView Pro AutoclavConmed Corporation2018-11-14300
K173822Anchor Tissue Retrieval System by CONMEDConmed Corporation2018-09-112670
K180763CuffLink Implant System BiocompositeConmed Corporation2018-07-191180
K172516SurgiQuest AIRSEAL iFS SystemConmed Corporation2018-03-162070
K172940ANCHOR Tissue Retrieval SystemConmed Corporation2017-10-18220
K172671HelixAR Electrosurgical Generator with Argon Beam CoagulatioConmed Corporation2017-10-04290
K171725CuffLink Implant SystemConmed Corporation2017-09-08880
K171592CrossFT™ Knotless Biocomposite Suture Anchor with DisposableConmed Corporation2017-08-29900
K170501CrossFT Knotless Biocomposite Suture Anchor with Disposable Conmed Corporation2017-03-17240
K163258CrossFT Knotless Suture Anchor with Disposable DriverConmed Corporation2017-01-25650
K151229ABC D-FLEX PROBEConmed Corporation2016-06-023920
K161017True HD 3MOS Camera SystemConmed Corporation2016-05-09270
K152969ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAYConmed Corporation2016-03-311750
K152860HELIXAR ELECTROSURGICAL GENERATOR WITH ARGON BEAM COAGULATIOConmed Corporation2015-12-29900
K153499EDGE Arthroscopic Energy System, Arthroscopic Energy System Conmed Corporation2015-12-18110
K150936SureClipConmed Corporation2015-10-231990

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda