510(k) Clearances in 2023 — Page 40

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 40 of 67)
510(k) clearancesDetails
K223669 — SecurePortIV Advanced Catheter Securement AdhesiveAdhezion Biomedical, LLC Jun 12, 2023
K221888 — Genadyne Hybrid Foam DressingsGenadyne Biotechnologies, Inc. Jun 12, 2023
K231466 — RxSight Insertion DeviceRxsight, Inc. Jun 12, 2023
K231022 — Pounce™ Thrombectomy SystemSurmodics,Inc. Jun 12, 2023
K230397 — Cut Screw - Percutaneous Compression ScrewGM Dos Reis Industria E Comercio Ltda. Jun 12, 2023
K223078 — Atellica® CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics, Inc. Jun 12, 2023
K213754 — SpiroHome Personal, SpiroHome ClinicInofab Saglik Teknolojileri A.S Jun 12, 2023
K223361 — BMR 1900 PHISIOSorin Group Italia S.R.L. Jun 10, 2023
K230776 — Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro)Shenzhen Lutejiacheng Technology Co., Ltd. Jun 9, 2023
K223091 — CT Perfusion V1.0Olea Medical Jun 9, 2023
K230293 — TheraFace MaskTherabody, Inc. Jun 9, 2023
K230586 — Renuvion® Micro HandpieceApyx Medical Corporation Jun 9, 2023
K231359 — RODIN™ Expandable Lumbar Cage SystemCtl Medical Corporation Jun 9, 2023
K230992 — DJF Intravascular Administration SetYangzhou Wei DE LI Trade Co., Ltd. Jun 9, 2023
DEN220078 — EroxonFutura Medical Developments Limited Jun 9, 2023
K231347 — BruxZir™ TintEFX Coloring LiquidPrismatik Dentalcraft, Inc. Jun 9, 2023
K220498 — NovoGen Wound MatrixNovabone Products, LLC Jun 9, 2023
K223865 — HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference SensorEdwards Lifesciences, LLC Jun 9, 2023
K230512 — Gamma4 SystemStryker GmbH Jun 9, 2023
K230779 — Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl CitrateShanxi Hongjin Plastic Technology Co., Ltd. Jun 9, 2023
K222450 — LVIS NeuroMatchLVIS Corporation Jun 9, 2023
K230905 — OrthoPulse 2.0E (OPi2E-100)Biolux Technology GmbH Jun 9, 2023
K231037 — MyKnee UNI-STMedacta International S.A. Jun 9, 2023
K230892 — Fixone Biocomposite AnchorAju Pharm Co., Ltd. Jun 9, 2023
K230744 — Acumed Acutrak 3 Headless Compression Screw SystemAcumed, LLC Jun 9, 2023
K230728 — JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD MonitorNanjing Jusha Display Technology Co., Ltd. Jun 9, 2023
K231368 — Bemer Therapy System EvoBemer Int AG Jun 9, 2023
K230502 — Ear Pressure Relief Device(Model:ER813B)Ningbo Albert Novosino Co., Ltd. Jun 9, 2023
K230768 — M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. Jun 9, 2023
K230505 — Orthopantomograph™ OP 3D LXPalodex Group OY Jun 9, 2023
K230709 — Auryon Atherectomy SystemEximo Medical, Ltd. Jun 9, 2023
K230008 — Ablamap® SystemAblacon, Inc. Jun 8, 2023
K231042 — Disposable Laparoscopic TrocarChangzhou Ankang Medical Instruments Co., Ltd. Jun 8, 2023
K222001 — Irreversible Electroporation Ablation Generator, Irreversible Electroporation ProbeZhejiang Curaway Medical Technology Co., Ltd. Jun 8, 2023
K230057 — Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC Jun 8, 2023
K231350 — OCD MT Cap (85-00397-000)Neuronetics Jun 8, 2023
K222762 — SIDDHARTH-II;IMPACTPanacea Medical Technologies Pvt. , Ltd. Jun 8, 2023
K222792 — SNUCONE Tissue Level Implant SystemSnucone Co., Ltd. Jun 8, 2023
K222684 — XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative FiStryker Spine Jun 8, 2023
K230659 — Zionic AestheticTermosalud Jun 8, 2023
K223918 — AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D HubPhilips Medical Systems Nederland B.V. Jun 8, 2023
K230715 — Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd. Jun 8, 2023
K214124 — AlloX2 Pro Tissue ExpandersSientra, Inc. Jun 8, 2023
K222248 — Infrared ThermometerAlicn Medical Shenzhen, Inc. Jun 7, 2023
K231360 — Ambra PACSDicom Grid Dba Ambra Health Jun 7, 2023
K231170 — C350/C350G LCD Monitor; M550/M550G LCD MonitorNanjing Jusha Display Technology Co., Ltd. Jun 7, 2023
K231002 — Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless)Suzhou Endophix Co., Ltd. Jun 7, 2023
K213611 — Fenom ProCaire Diagnostics, Inc. Jun 7, 2023
K223059 — Xenco Medical InterAlign Cervical Interbody SystemXenco Medical, LLC Jun 7, 2023
K230381 — Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical IndicatorCs Medical, LLC Jun 7, 2023
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