510(k) Clearances in 2023 — Page 6

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 6 of 67)
510(k) clearancesDetails
K230137 — Reliance® Fusion Sterilization WrapsAhlstrom-Munksjo Nonwovens, LLC Dec 7, 2023
K233562 — LINQ II Insertable Cardiac MonitorMedtronic, Inc. Dec 6, 2023
K231675 — OneRF Ablation SystemNeuroone Medical Technologies Corp. Dec 6, 2023
K233334 — Aquilion Serve SP (TSX-307B/1) V1.3Canon Medical Systems Corporation Dec 6, 2023
K231125 — 2008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC Dec 6, 2023
K230677 — Cork Medical VERSA Negative Pressure Wound System (VCMPP-100)Cork Medical Dec 6, 2023
K231465 — Q-Pad Test SystemQurasense Dec 6, 2023
K232206 — SOMATOM Pro.PulseSiemens Medical Solutions USA, Inc. Dec 6, 2023
K233521 — QT ECG (QTERD100)QT Medical, Inc. Dec 6, 2023
K222930 — Evolve Nitric Oxide Delivery SystemMallinckrodt Manufacturing, LLC Dec 6, 2023
K233042 — Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl CitrateShandong Intco Medical Products Co, Ltd. Dec 6, 2023
K232769 — BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed) Dec 6, 2023
K233597 — Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc. Dec 6, 2023
K230712 — SG Lanset I, SG Lancets, Soft LancetsSewon Medical Co. Dec 6, 2023
K231615 — Disposable Endoscopic BipolarJiangsu Hope Biomedical Science & Technology Co., Ltd. Dec 5, 2023
K232434 — BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived KitBd Dec 5, 2023
K232814 — Electronic Blood Pressure MonitorZhuhai Yueja Medical Device Technology Co., Ltd. Dec 5, 2023
K222057 — THERMOCLICKT&R BIOFAB CO., Ltd. Dec 5, 2023
K232220 — SS Abutment SystemOsstem Implant Co., Ltd. Dec 5, 2023
K230734 — Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)Precision Healing, LLC Dec 5, 2023
K231005 — Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2Supermax Healthcare Canada-Supermax Medical Dec 5, 2023
K233490 — SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC Dec 5, 2023
K231230 — Optina-4C (MHRC-C1N)Optina Diagnostics, Inc. Dec 5, 2023
K223170 — Electronic Blood Pressure Monitor, model: HTD6602USHetaida Technology Co., Ltd. Dec 5, 2023
K233568 — Ceevra Reveal 3+Ceevra, Inc. Dec 5, 2023
K231923 — Liberty SI Lateral Implant SystemSpinal Simplicity, LLC Dec 5, 2023
K232440 — Adravision PerioAdra Corporation Dec 5, 2023
K233335 — Tablo® Hemodialysis SystemOutset Medical, Inc. Dec 5, 2023
K232308 — Monarch Blood Collection SetThe Monarch Company Dec 4, 2023
K223783 — cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc. Dec 4, 2023
K232693 — Tyber Medical Distal Radius Plating SystemTyber Medical, LLC Dec 4, 2023
K220525 — RESPONDER Polysaccharide HemostatStarch Medical, Inc. Dec 4, 2023
K233347 — Verruca-Freeze® HCryosurgery, Inc. Dec 4, 2023
K230724 — arcad® 2.0 Duo & Quadro osteosynthesis compressive staplesNovastep Dec 4, 2023
K230648 — Access hsTnIBeckman Coulter, Inc. Dec 4, 2023
K232581 — Medical Disposable Sterile Needle ElectrodeSuzhou Haishen Medical Device Associates Co., Ltd. Dec 4, 2023
DEN230045 — SonuSound Health Systems, Inc. Dec 4, 2023
K231895 — Maxtec MaxBlend2+pMaxtec, LLC Dec 4, 2023
K232932 — Intense Pulse Light Therapeutic ApparatusShenzhen Greatro Electronic Technology Co., Ltd. Dec 4, 2023
K233397 — Cosine-10TM Diagnostic CatheterMedtronic, Inc. Dec 2, 2023
K231476 — TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitoring SystemSinocare, Inc. Dec 1, 2023
K232249 — PENTAX Medical Gas/Water Feeding Valve OE-B14Pentax Of America, Inc. Dec 1, 2023
K233529 — BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free ConnectorBecton Dickinson Infusion Therapy Systems, Inc. Dec 1, 2023
K230528 — Extension SetMedcaptain Life Science Co., Ltd. Dec 1, 2023
K230391 — BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson And Company Dec 1, 2023
K233159 — pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504Fresenius Medical Care Renal Therapies Group, LLC Dec 1, 2023
K231057 — Antibacterial Gel Wound DressingWinner Medical Co., Ltd. Dec 1, 2023
K233149 — CATHTONG III Tapered PICC CatheterL&Z Us, Inc. Dec 1, 2023
K233301 — ULTRApulse Alpha CO2 Laser System, Delivery Devices and AccessoriesLumenis Be, Ltd. Dec 1, 2023
K232758 — Comatryx OTCStrukmyer Medical, LLC Dec 1, 2023
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