510(k) Clearances in 2023 — Page 60

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 60 of 67)
510(k) clearancesDetails
K230241 — Jumong GeneralSg Healthcare Co, Ltd. Feb 23, 2023
K221741 — TRAUS Air Dental HandpieceSaeshin Precision Co., Ltd. Feb 22, 2023
K230197 — BoneMRI v1.6Mriguidance B.V. Feb 22, 2023
K221629 — Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)Covidien Feb 22, 2023
K221329 — Eyer Retinal Camera NM-STDPhelcom Technologies Feb 22, 2023
K212587 — 3D-RD-SRadiopharmaceutical Imaging And Dosimetry, LLC Feb 22, 2023
K230208 — Swoop® Portable MR Imaging System™Hyperfine, Inc. Feb 22, 2023
K221469 — PATI (Protector Against Tongue Injury)Neurovice, LLC Feb 22, 2023
K223298 — Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)Shandong Intco Medical Products Co, Ltd. Feb 22, 2023
K223492 — eFOLDi Scooter, LiteSuntech UK , Ltd. Feb 22, 2023
K230371 — The Alma Soprano TitaniumAlma Lasers, Inc. Feb 22, 2023
K230180 — Rosa Knee SystemOrthosoft Inc (D/B/A Zimmer Cas) Feb 22, 2023
K230201 — Disposable Pre-calibrated Brain Biopsy Needle 2.0PAJUNK GmbH Medizintechnologie Feb 22, 2023
K221903 — Delta III ProDornier Medtech America, Inc. Feb 22, 2023
K222259 — NEONA 1.5T MRI SystemTime Medical Limited Feb 21, 2023
K223612 — Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)Ranfac Corporation Feb 21, 2023
K223643 — Verifine® Ease Lancing Device, Verifine® Lancing DevicePromisemed Hangzhou Meditech Co., Ltd. Feb 21, 2023
K223537 — FreeStyle Libre 2 System, FreeStyle Libre 3 SystemAbbott Diabetes Care, Inc. Feb 21, 2023
K213348 — BOND MMR Antibody PanelLeica Biosystems Newcastle, Ltd. Feb 21, 2023
K222184 — Introducer Sheath KitsBeijing Demax Medical Technology Co.,Ltd Feb 21, 2023
K214068 — Quantia IgEBiokit, S.A. Feb 21, 2023
K220214 — Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd. Feb 18, 2023
K221861 — FloNavi Endoscopic Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc. Feb 18, 2023
K222588 — Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1Iweecare Co., Ltd. Feb 17, 2023
K221483 — FlowSaver Blood Return SystemInari Medical, Inc. Feb 17, 2023
K221043 — Doctor Tecar Plus, Doctor Tecar SmartMectronic Medicale S.R.L. Feb 17, 2023
K223497 — Spectrum Saliva Collection DeviceSpectrum Solutions, LLC Feb 17, 2023
K222226 — EONDominion Aesthetic Technologies, Inc. Feb 17, 2023
K223466 — Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS101STERIS Corporation Feb 17, 2023
K223798 — Glidewell TuffSplint™ Appliance ResinPrismatik Dentalcraft, Inc. Feb 17, 2023
K223545 — APRO 70 Catheter and Alembic Aspiration TubingAlembic, LLC Feb 17, 2023
DEN210022 — PMD-200Medasense Biometrics , Ltd. Feb 17, 2023
K222695 — troCarWash™ SystemBiotex, Inc. Feb 17, 2023
K222977 — DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStripMacromedics BV Feb 17, 2023
K221513 — Equashield Closed System Transfer DeviceEquashield Medical , Ltd. Feb 17, 2023
K222971 — ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Fixation Device; ULTRABUTTON TIB MEDIUM Adjustable Fixation Device; ULTRABUTTON TIB LARGE Adjustable Fixation DeviceSmith & Nephew, Inc. Feb 17, 2023
K221645 — PROstep(TM) MIS 5mm Chamfer Screw SystemWright Medical Technology Feb 17, 2023
K220276 — Infrared Thermometer TET-351Truly Instrument Limited Feb 17, 2023
K213755 — Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion systemGbs Commonwealth Co., Ltd. Feb 17, 2023
K223897 — Excipio LV Thrombectomy DeviceContego Medical, Inc. Feb 17, 2023
K223820 — EzDent-i / E2 / Prora View/ Smart M ViewerEwoosoft Co., Ltd. Feb 17, 2023
K230118 — Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd. Feb 16, 2023
K223733 — CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4Biosense Webster, Inc. Feb 16, 2023
K222065 — Passeo-35 Xeo Peripheral Dilatation CatheterBiotronik, Inc. Feb 16, 2023
K223832 — Vivid S60N, Vivid S70NGe Medical System Ultrasound And Primary Care Diagnostics Feb 16, 2023
K212194 — Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting SystemStryker Corporation Feb 16, 2023
K220698 — Bambino 3, S3 and S3 Swing, U3 and U3 Light, XPanthera AB Feb 16, 2023
K223524 — IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03Morlaser Shenzhen Co., Ltd. Feb 16, 2023
K222755 — uMR 680Shanghai United Imaging Intelligence Co., Ltd. Feb 16, 2023
K223477 — PMMA Blocks for Dental UseAidite (Qinhuangdao) Technology Co., Ltd. Feb 16, 2023
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