510(k) Clearances in 2023 — Page 49

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 49 of 67)
510(k) clearancesDetails
K230783 — Anatase Spine Surgery Navigation SystemRemex Medical Corp. Apr 21, 2023
K223300 — Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and InstrumentGeotek Medikal Ltd Sti Apr 21, 2023
K230816 — Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd. Apr 21, 2023
K222210 — AEON Endoscopic StaplerLexington Medical, Inc. Apr 21, 2023
K230789 — Knee+Pixee Medical Apr 21, 2023
K222291 — Paradigm SystemProprio, Inc. Apr 21, 2023
K223501 — ViewFinder Software Version 1.1Elaitra, Ltd. Apr 21, 2023
K230468 — EzDent WebEwoosoft Co., Ltd. Apr 21, 2023
K221142 — Kyphoplasty Balloon SystemOK Medinet Korea Co., Ltd. Apr 21, 2023
K221742 — CONNEQT PULSEAtcor Medical Apr 21, 2023
K230808 — PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc. Apr 21, 2023
K222604 — dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version SDentona AG Apr 21, 2023
K230819 — OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc. Apr 21, 2023
K230811 — Digital Intraoral X-Ray SensorIray Imaging Technology (Haining) Limited Apr 21, 2023
K230084 — HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. Apr 21, 2023
K230565 — HILINE™ Fixation SystemGlobus Medical, Inc. Apr 20, 2023
DEN220082 — Breast Implant Removal Device (BIRD)Gaylord Solutions, LLC Apr 20, 2023
K223238 — STARband 3DOrthomerica Products, Inc. Apr 20, 2023
K223662 — Neodent Implant System - Helix Short Surgical Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A. Apr 20, 2023
K230785 — Precision1, Precision1 for AstigmatismAlcon Laboratories, Inc. Apr 20, 2023
K222261 — Flexible Video-Choledochoscope SystemShanghai SeeGen Photoelectric Technology Co., Ltd. Apr 20, 2023
K212220 — ArtFX Spinal Fixation SystemArtfx Medical, LLC Apr 20, 2023
K230807 — Deep Learning Image ReconstructionGe Healthcare Japan Corporation Apr 20, 2023
K223287 — VelacurSonic Incytes Apr 20, 2023
K211153 — Inomax DSIRMallinckrodt Manufacturing, LLC Apr 20, 2023
K222095 — BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101Thrombolex, Inc. Apr 20, 2023
K223768 — RadiForce RX270Eizo Corporation Apr 20, 2023
K220981 — SUPERPLAST Double-Occluder, SUPERPLAST Vascular ProbeFehling Surgical Instruments, Inc. Apr 20, 2023
K221042 — Renova RP Centesis PumpGi Supply, Inc. Apr 19, 2023
K223552 — Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning CranialBrainlab AG Apr 19, 2023
K221220 — Montross Extremity Medical Hemi Implant SystemMontross Extremity Medical Apr 19, 2023
K223201 — TAP LancetYourbio Health, Inc. Apr 19, 2023
K230766 — Altus Spine Monaco Pedicle Screw SystemAltus Spine Apr 19, 2023
K211748 — Selux AST System; Model AST Gen 1.0Selux Diagnostics, Inc. Apr 19, 2023
K220288 — NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral displacement needle free connector, nPulse K150 Needle Free ConnectorNp Medical, Inc. Apr 19, 2023
K230053 — SimpliFix Hip SystemStabiliz Orthopaedics, Inc. Apr 19, 2023
K223168 — Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ BiosurfaceMedtronic, Inc. Apr 19, 2023
K230090 — Diode Laser Hair RemovalWuhan Lotuxs Technology Co., Ltd. Apr 19, 2023
K230023 — ART-PlanTherapanacea Sas Apr 19, 2023
K223784 — Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200Deltronix Equipamentos Ltda Apr 18, 2023
K213170 — SENSOSEEG Depth ElectrodesSensomedical Labs, Ltd. Apr 18, 2023
K230494 — ClotTriever BOLD CatheterInari Medical, Inc. Apr 18, 2023
K223513 — UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC Apr 18, 2023
K221895 — Terumo Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation Apr 18, 2023
K230820 — SofWave SystemSofwave Medical, Ltd. Apr 18, 2023
K230698 — Anivia SG1000 Pump ConsoleApmtd, Inc. Apr 18, 2023
K230764 — OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies Apr 18, 2023
K230429 — Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization DeviceRapid Medical Ltd. Apr 17, 2023
K230772 — Quantib ProstateQuantib B.V. Apr 17, 2023
K222469 — TIB AbutmentsSouthern Implants (Pty), Ltd. Apr 17, 2023
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