510(k) Clearances in 2023 — Page 63

3,346 510(k) clearances total

Browse FDA 510(k) clearances granted in 2023. RegDataLab tracks 3,346 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2023 (page 63 of 67)
510(k) clearancesDetails
K222574 — Simparo Anchor Line Fixation SystemSimparo, Inc. Feb 4, 2023
DEN220044 — Active Anthrax DetectTM Plus Rapid TestInBios International, Inc. Feb 3, 2023
K220996 — DuobladeCnc Technologies Feb 3, 2023
K223395 — Luna Dental Implant SystemShinhung Mst Co., Ltd. Feb 3, 2023
K230059 — Digital Flat Panel DetectorRay Imaging Technology (Haining) Limited Feb 3, 2023
K221253 — SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative ControlMaine Molecular Quality Controls, Inc. Feb 3, 2023
K223648 — Cook® Spectrum® 2 MRC Central Venous CatheterCook Advanced Technologies Feb 3, 2023
K220337 — GaiaBone Bioabsorbable Bone GraftCorliber (Shenzhen) Medical Device Co., Ltd. Feb 3, 2023
K220296 — Manta Ray TDF SpacerSeaSpine Orthopedics Corporation Feb 3, 2023
K230051 — 14F iSLEEVE™ Introducer SetBoston Scientific Corporation Feb 3, 2023
K222153 — Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)Microlife Intellectual Property GmbH Feb 3, 2023
K223679 — Access AMHBeckman Coulter, Inc. Feb 3, 2023
K223876 — SMR Shoulder SystemLima Corporate S.P.A. Feb 3, 2023
K222950 — AcuPebble OX100Acurable Limited Feb 3, 2023
K223026 — NES Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterNortheast Scientific, Inc. Feb 3, 2023
K223051 — Pre-Formed Silicone BlockInternational Medical Devices, Inc. Feb 3, 2023
K221491 — Anivia SG1000 Pump ConsoleApmtd, Inc. Feb 3, 2023
K213954 — BIOFIRE SPOTFIRE Respiratory (R) PanelBiofire Diagnostics Feb 3, 2023
K221348 — IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)Philips Medizin Systeme Böblingen GmbH Feb 3, 2023
K222063 — MONTAGE Settable, Resorbable Bone PuttyOrthocon, Inc. Feb 3, 2023
K223481 — VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL)bioMerieux, Inc. Feb 3, 2023
K223362 — Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc. Feb 2, 2023
K222671 — DeltaScan PatchProlira B.V. Feb 2, 2023
K222211 — Implant Direct Dental Implant Systems Portfolio - MR ConditionalImplant Direct Sybron Manufacturing, LLC Feb 2, 2023
K222803 — OncospaceOncospace, Inc. Feb 2, 2023
K221356 — Wee BellWee Medical Feb 2, 2023
K222680 — DeltaScan MonitorProlira B.V. Feb 2, 2023
K221515 — StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, LithoVue Elite Single Use Digital Flexible Ureteroscope Reverse w/Pressure MonitoringBoston Scientific Corporation Feb 2, 2023
K223406 — SmartRelease Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments Feb 2, 2023
K210751 — S.E.A.L. Hemostatic Wound SprayBc3 Technologies, Inc. Feb 2, 2023
K221781 — Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KHGuangdong Optomedic Technologies, Inc. Feb 2, 2023
K222422 — Polaris Valve Electronic Reading InstrumentSophysa Feb 2, 2023
K213545 — Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869Steelco S.P.A. Feb 2, 2023
K223284 — SutureLoc™ ImplantArthrex, Inc. Feb 2, 2023
K223627 — PreView-III™ Anterior Cervical Plate SystemNexus Spine, LLC Feb 2, 2023
K220126 — Geonic Nasal Aspirator, Geonic Nasal CleanerGeon Corporation Feb 2, 2023
K230012 — Atomica PlannerAtomica Technology, Inc. Feb 2, 2023
K221943 — EmbedMed3D Lifeprints UK , Ltd. Feb 1, 2023
K213480 — 31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head CoilRapid Biomedical GmbH Feb 1, 2023
K222970 — LVivo IQSDia Imaging Analysis, Ltd. Feb 1, 2023
K230020 — BriefCaseAidoc Medical , Ltd. Feb 1, 2023
K221168 — Tinnitogram Signal GeneratorGoldenear Company, Inc. Feb 1, 2023
K222863 — Garment ElectrodesTone-A-Matic International, Inc. Feb 1, 2023
K222751 — LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd. Feb 1, 2023
K223330 — Certas Plus Programmable ValvesIntegra Lifesciences Production Corporation Feb 1, 2023
K223396 — Rapid RV/LVIschemaview, Inc. Feb 1, 2023
DEN220014 — RefleXion Medical Radiotherapy System (RMRS)Reflexion Medical, Inc. Feb 1, 2023
K223117 — V-SPERM WASHVitromed GmbH Jan 31, 2023
K221200 — XBody Go USA, XBody Pro USAXbody Hungary Kft. Jan 31, 2023
K223351 — Naviswiss KneeNaviswiss AG Jan 31, 2023
← Previous Page 63 of 67 Next →