510(k) Clearances in 2023 — Page 36

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 36 of 67)
510(k) clearancesDetails
K222745 — Axial3D InsightAxial Medical Printing Limited Jul 3, 2023
K230025 — IVYLASER Handhold Hair Removal MachineIvylaser (Beijing) Technology Co.,Ltd Jul 3, 2023
K230569 — Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 )Cardinalhealth Jul 3, 2023
K230720 — LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001Light Tree Ventures Europe B.V. Jul 3, 2023
K230487 — Dental Lithium Disilicate Glass-CeramicFuzhou Rick Brown Biomaterials Co., Ltd. Jul 3, 2023
K231280 — CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone CementCarboFix Orthopedics , Ltd. Jul 3, 2023
K221664 — CLEARinse CTS Specimen Collection and Transport SystemAardvark Medical, Inc. Jul 3, 2023
K231653 — BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular CatheterThrombolex, Inc. Jul 3, 2023
K230901 — Premier HpSA Flex (619096)Meridian Bioscience, Inc. Jul 3, 2023
K230725 — NB Implant SystemArum Dentistry Co., Ltd. Jul 1, 2023
K231267 — ClearTipFinemedix Co., Ltd. Jun 30, 2023
K230933 — REMI Remote EEG Monitoring SystemEpitel, Inc. Jun 30, 2023
K230935 — Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae)Thermo Fisher Scientific Jun 30, 2023
K231252 — Ventana™ L Spinal SystemSpinal Elements, Inc. Jun 30, 2023
K231689 — iFuse TORQ® Implant SystemSI-BONE, Inc. Jun 30, 2023
K231588 — ViewFlex™ Eco Reprocessed ICE CatheterABBOTT MEDICAL Jun 30, 2023
K222466 — AirTomBilab Jun 30, 2023
K230156 — 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide CatheterMedtronic Vascular Jun 30, 2023
K231596 — IOB Temperature Management SystemIob Medical, Inc. Jun 30, 2023
K231585 — Vantage PSI System3D Systems, Inc. Jun 30, 2023
K230930 — enspire 3000 Cleaning and Liquid Chemical Sterile Processing SystemSTERIS Corporation Jun 30, 2023
K221294 — preCARDIA Occlusion SystemAbiomed, Inc. Jun 30, 2023
K223694 — Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)Duearity AB Jun 30, 2023
K230469 — Compact Wearable PumpLansinoh Laboratories Jun 30, 2023
K230944 — MeMed BVMeMed Diagnostics, Ltd. Jun 30, 2023
K223854 — Unistik® ShieldLock, Unistik VacuFlipOwen Mumford, Ltd. Jun 30, 2023
K212409 — Ulspira TS Nitric Oxide Therapy SystemAirgas Therapeutics Jun 30, 2023
K231264 — Easy On Universal Glaze & StainDoctus Global Jun 30, 2023
K213253 — Pixyl.NeuroPixyl SA Jun 30, 2023
K223135 — AblatePal Radiofrequency Ablation SystemCompal Electronics, Inc. Jun 30, 2023
K230917 — FebriDx Bacterial / Non-bacterial Point of Care AssayLumos Diagnostics, Inc. Jun 30, 2023
K230991 — PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic) Jun 30, 2023
K230456 — SGM Femoral Nail SystemChangzhou Geasure Medical Apparatus And Instruments Co., Ltd. Jun 30, 2023
K223374 — Blood Pressure MonitorGuangdong Transtek Medical Electronics Co., Ltd. Jun 30, 2023
K230052 — Inogen Rove 6Inogen, Inc. Jun 30, 2023
K230866 — HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC Jun 29, 2023
K230337 — EarliPointEarlitec Diagnostics, Inc. Jun 29, 2023
K231553 — OverStitch NXT Endoscopic Suturing SystemApollo Endosurgery, Inc. Jun 29, 2023
K231691 — Phantom XL Insulated DilatorsTeDan Surgical Innovations, Inc. Jun 29, 2023
K223596 — SQ.line KERRISONAesculap, Inc. Jun 29, 2023
K231101 — Flume CatheterFlume Catheter Company, Ltd. Jun 29, 2023
DEN200052 — KidneyIntelX.dkdRenalytix Ai, Inc. Jun 29, 2023
K230374 — Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®)Dongguan TT Medical, Inc. Jun 29, 2023
K222933 — MYAHVisia Imaging S.R.L. Jun 29, 2023
K230176 — Upper Arm Blood Pressure MonitorShenzhen Yolanda Technology Co., Ltd. Jun 29, 2023
K223047 — NeuroSwift ProNeurobit Technologies Co., Ltd. Jun 29, 2023
K230595 — OsteoCentric ACL Fixation SystemOsteoCentric Technologies Jun 29, 2023
K231647 — XENOVIEW 3.0T Chest CoilPolarean, Inc. Jun 29, 2023
K231549 — Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific Corporation Jun 29, 2023
K221436 — F&P 950 Accessory Breathing Circuit KitsFisher & Paykel Healthcare, Ltd. Jun 29, 2023
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