510(k) Clearances in 2023 — Page 66

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 66 of 67)
510(k) clearancesDetails
K223795 — FairFix QT Adjustable ButtonMedacta International S.A. Jan 17, 2023
K223794 — hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSCefla S.C. Jan 17, 2023
K223010 — Portable X-ray SystemIray Technology Taicang , Ltd. Jan 17, 2023
K223222 — Plasma IQNeauvia North America, Inc. Jan 17, 2023
K221754 — Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC)Winner Medical Co., Ltd. Jan 17, 2023
K220649 — ElucisRealize Medical, Inc. Jan 17, 2023
K220884 — Disposable Endoscope Valve SetsSml Med-Tech Solutions Limited Jan 17, 2023
K222941 — Halcyon, Ethos Radiotherapy SystemVarian Medical Systems, Inc. Jan 17, 2023
K213514 — Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. (Subsidiary Of Collidion, Inc. Jan 13, 2023
K221020 — Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 FPotrero Medical, Inc. Jan 13, 2023
K223405 — Access TestosteroneBeckman Coulter, Inc. Jan 13, 2023
K223474 — PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd. Jan 13, 2023
K221542 — Galileo Vertebral Body Replacement DeviceBright Spine Jan 13, 2023
K223221 — Non-Sterile Powder Free Nitrile Examination GlovesDynacare Sdn Bhd Jan 13, 2023
K220495 — SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd. Jan 13, 2023
K223183 — Light-Guide CablesOlympus Winter & Ibe GmbH Jan 13, 2023
K223746 — Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ ConsoleZoll Circulation, Inc. Jan 13, 2023
K221317 — S-MonoShinhung Mst Co., Ltd. Jan 13, 2023
K223429 — Contour KneeQuality Electrodynamics, LLC Jan 13, 2023
K222782 — Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199;YD-1193S,YD-1195S,YD-1196S,YD-1198S,YD-1199S)Zhejiang Carebao Co., Ltd. Jan 13, 2023
K221933 — MONTAGE Settable, Resorbable Bone PuttyOrthocon, Inc. Jan 13, 2023
K221682 — Ideal Med Pro 3-Ply Disposable Face MaskJsn Holdings, LLC Jan 13, 2023
K221252 — Scivita 4KINSIGHT ICG Imaging SystemScivita Medical Technology Co., Ltd. Jan 13, 2023
K223480 — Medipoint Blood LancetsMedipoint Holdings, LLC Jan 13, 2023
K222170 — Power Acute Triple Lumen Hemodialysis CatheterHealth Line International Corporation Jan 13, 2023
K221755 — Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressingWinner Medical Co., Ltd. Jan 13, 2023
K222171 — Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+Magstim Company, Ltd. Jan 13, 2023
K223748 — Nitrile Exam Gloves (Chemotherapy Drug Tested)Us Medical Glove Company, LLC Jan 13, 2023
K223031 — Vibrant SystemVibrant, Ltd. Jan 13, 2023
K223502 — MR Diffusion Perfusion Mismatch V1.0Olea Medical Jan 13, 2023
K222913 — s-Clean Link AbutmentDentis Co., Ltd. Jan 13, 2023
K214078 — Silk’n ToothwaveHome Skinovations , Ltd. Jan 13, 2023
K222150 — PreXion3D ExpeditionPrexion Corporation Jan 12, 2023
K221873 — NeoGen PSR SystemEnergist Limited Jan 12, 2023
K223731 — NuVasive Modulus-C Interbody SystemNuvasive, Inc. Jan 12, 2023
K223644 — Neuronaute with IceCap 2 & IceCap 2 SmallBioserenity Jan 12, 2023
K223363 — MAMMOVISTA B.smart (VB70)Siemens Medical Solutions USA, Inc. Jan 12, 2023
K222011 — HandX Instrument - Monopolar SpatulaHuman Xtensions , Ltd. Jan 12, 2023
K222830 — Rainbow 360Kerr Corporation Jan 12, 2023
K222458 — AIBOLIT 3D+Aibolit Technologies, LLC Jan 12, 2023
K222976 — MU SystemDentis Co., Ltd. Jan 12, 2023
K221774 — Garmin ECG AppGarmin International, Inc. Jan 12, 2023
K223782 — Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler SetAmbu A/S Jan 12, 2023
K223931 — Dexcom G6 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. Jan 11, 2023
K223738 — Alpha Control Liner System (ACLS)Coapt Jan 11, 2023
K221278 — Transducer Probe CoverHony Medical Co., Ltd. Jan 11, 2023
K191111 — DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH Jan 11, 2023
K223465 — RadianceTx Radionuclide Brachytherapy SourceRadiance Therapeutics, Inc. Jan 11, 2023
K222181 — Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl CitrateIconic Medicare Sdn Bhd Jan 11, 2023
K223764 — INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc. Jan 11, 2023
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