510(k) Clearances in 2024 — Page 6

3,129 510(k) clearances total

Browse FDA 510(k) clearances granted in 2024. RegDataLab tracks 3,129 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2024 (page 6 of 63)
510(k) clearancesDetails
K241073 — DZ-Tabone Intervertebral Body Fusion DeviceShenzhen Dazhou Medical Technology Co., Ltd. Dec 6, 2024
K242524 — SyMRISyntheticmr AB (Publ.) Dec 6, 2024
K242645 — INA Moisturizing Intimate Lubricant Water-Based Personal LubricantProject Chemistry, Inc. Dec 6, 2024
K241878 — Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)Stryker Corporation (Tornier, Inc.) Dec 6, 2024
K242710 — Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro)Shenzhen Jianchao Intelligent Technology Co., Ltd. Dec 6, 2024
K241674 — OSTEOPAL® VHeraeus Medical GmbH Dec 5, 2024
K243526 — MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. Dec 5, 2024
K242740 — Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO)Liaoning Rachcera Material Technology Co., Ltd. Dec 5, 2024
K242703 — LW Pre-milled AbutmentOssvis Co., Ltd. Dec 5, 2024
K243463 — BIOFIRE FILMARRAY Tropical Fever PanelBiofire Diagnostics, LLC (Biomerieux) Dec 5, 2024
K243444 — BIOCERAM AZUL® HEADKyocera Corporation Dec 5, 2024
K241128 — TDM Plate and Screw SystemTdm Co., Ltd. Dec 5, 2024
DEN240025 — VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)Ventana Medical Systems, Inc. Dec 5, 2024
K243435 — Magnetic Localization Patch Kit (AFR-00021)Medtronic, Inc. Dec 5, 2024
K243447 — Rapid Surgical Plan (RSP-SW-001)Navbit Pty, Ltd. Dec 5, 2024
K242653 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mLThermo Fisher Scientific Dec 5, 2024
K242525 — iTOF®Nerbio Medical Software Platforms, Inc. Dec 5, 2024
K242185 — Rextar ProRaypia Co., Ltd. Dec 4, 2024
K240671 — XBeam (v2)Xstrahl, Ltd. Dec 4, 2024
K242831 — Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics Dec 4, 2024
K243180 — SSPC NXT Delivery CatheterCenterPoint Systems, LLC Dec 4, 2024
K242686 — Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A. Dec 4, 2024
K242301 — Socrates 38 CatheterScientia Vascular, Inc. Dec 4, 2024
K243417 — RelieVRxAppliedvr Dec 4, 2024
K242395 — Nanox.ARCNano-X Imaging , Ltd. Dec 4, 2024
K242348 — Locking Screw,CoCrMoDouble Medical Technology, Inc. Dec 4, 2024
K242184 — Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);Alcon Laboratories, Inc. Dec 4, 2024
K243265 — Ion 3DSurGenTec, LLC Dec 4, 2024
K241197 — DeepRhythmAIMedicalgorithmics S.A. Dec 4, 2024
K242685 — Atellica® CH Creatinine_3 (Crea3)Siemens Healthcare Diagnostics, Inc. Dec 4, 2024
K243475 — Chemical Indicator for enspire CLCSPS (LCC015)STERIS Corporation Dec 4, 2024
K242643 — CapsoCam Plus (SV-3) Capsule Endoscopy SystemCapsoVision, Inc. Dec 4, 2024
K243467 — Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)Osteonic Co., Ltd. Dec 3, 2024
K242188 — ClearRead CT CACRiverain Technologies, Inc. Dec 3, 2024
K243454 — Verruca-Freeze HCryosurgery, Inc. Dec 3, 2024
K241486 — Sofsilk™ Coated Braided Silk SutureCovidien Dec 3, 2024
K242861 — TrueLok ElevateOrthofix Srl Dec 3, 2024
K243470 — Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd. Dec 3, 2024
K243232 — GripMateSynthon Hispania S.L. Dec 2, 2024
K242619 — GroWell BT Hair Growth System (GW10042)Apira Science, Inc. Dec 2, 2024
K243418 — Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate TubingMicro Therapeutics, Inc. D/B/A Ev3 Neurovascular Dec 2, 2024
K223120 — Ventoux VC2; Ventoux VC3Flight Medical Innovations , Ltd. Dec 2, 2024
K243020 — MIDASVuIntravu, Inc. Dec 2, 2024
K240475 — Hintermann Series H2 Total Ankle SystemVilex, LLC Dec 2, 2024
K241871 — Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V. Dec 2, 2024
K243433 — enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemSTERIS Corporation Dec 2, 2024
K242225 — Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic CatheterSurgical Instrument Service And Savings, Inc. Nov 29, 2024
K243375 — Ruthless Spine RJBRuthless, LLC Dba Ruthless Spine Nov 29, 2024
K241628 — YO Home Sperm TestMedical Electronic Systems , Ltd. Nov 29, 2024
K241090 — Evie Med RingMovano Inc. Dba Movano Health Nov 29, 2024
← Previous Page 6 of 63 Next →