510(k) Clearances — Page 119

176,223 clearances total

Browse all FDA 510(k) medical device clearances. RegDataLab tracks 176,223 clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances (page 119 of 3,525)
ClearancesDetails
K241213 — PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)Pentax Of America, Inc. Dec 6, 2024
K240971 — 87 NeuGlide CatheterPiraeus Medical Dec 6, 2024
K240926 — PeekMed webPeek Health, S.A. Dec 6, 2024
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
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