510(k) Clearances in 2023 — Page 28

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 28 of 67)
510(k) clearancesDetails
K230581 — TOPA12 Portable X-ray UnitNeuf, Inc. Aug 16, 2023
K223922 — SOMNUM (V.1.1.2.)Honeynaps Co., Ltd. Aug 16, 2023
DEN220073 — Revi SystemBluewind Medical , Ltd. Aug 16, 2023
K232126 — EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler AnvilCovidien Aug 16, 2023
K230298 — Celsi MonitorHadleigh Health Technologies Aug 16, 2023
K231389 — Harvest Dental HD Gum StripHarvest Dental Products, LLC Aug 16, 2023
K231087 — Guided Surgery KitImplant Direct Sybron Manufacturing, LLC Aug 16, 2023
K222148 — HemoScreen Hematology AnalyzerPixcell Medical Technologies, Ltd. Aug 16, 2023
K223709 — Kyphoplasty Balloon CatheterJiangsu Changmei Medtech Co., Ltd. Aug 16, 2023
K230342 — Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd. Aug 16, 2023
K232141 — CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head)Medtronic Sofamor Danek USA, Inc. Aug 16, 2023
K230314 — Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)New Era Medicare Sdn. Bhd. Aug 16, 2023
K223479 — AQUAbase nXB.Braun Medical, Inc. Aug 16, 2023
K232116 — CoreLink Navigation InstrumentsCorelink, LLC Aug 16, 2023
K231491 — TA™ Stapler and Loading Unit with DST Series™ TechnologyCovidien Aug 16, 2023
K230577 — Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi Aug 16, 2023
K223874 — BAROguardParagonix Technologies Aug 15, 2023
K231750 — MA012 Aluminum wheelchair, MS019 steel wheelchairSichuan Ast Medical Equipment Co., Ltd. Aug 15, 2023
K231807 — primaLOK™ SP Interspinous Fusion SystemWenzel Spine, Inc. Aug 15, 2023
K231829 — Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical Aug 15, 2023
K231455 — Implant-One SystemImplant Logistics, Inc. Aug 15, 2023
K231301 — Vscan AirGE Medical Systems Ultrasound And Primary Care Diagnostics Aug 15, 2023
K231094 — Annalise Enterprise CTB Triage-OHAnnalise-Ai Pty , Ltd. Aug 15, 2023
K231838 — RxSight® Insertion Device (63002)Rxsight, Inc. Aug 15, 2023
K232127 — 21HQ513D, 32HL512D, 31HN713D, 32HQ713DLg Electronics.Inc Aug 15, 2023
K231583 — Route 92 Medical Full Length 054 Access SystemRoute 92 Medical, Inc. Aug 15, 2023
K231208 — Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG Aug 14, 2023
K231418 — ENDOGATOR™ Hybrid Irrigation TubingMedivators Aug 14, 2023
K223660 — SaintViewInviz Corporation Aug 14, 2023
K231905 — Electro-Spec Steri-CapsElectro-Spec, Inc. Aug 14, 2023
K230607 — SPICCA Cervical Fusion CagesSouthern Medical (Pty) , Ltd. Aug 14, 2023
K231054 — V-LaserWontech Co., Ltd. Aug 14, 2023
K232162 — Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 SphincterotomeBoston Scientific Corporation Aug 14, 2023
K231341 — Organic cotton tampon, Viscose tamponZhejiang Tianqing Manufacturing Technology Group Co., Ltd. Aug 14, 2023
K230663 — DensityJeisys Medical, Inc. Aug 14, 2023
K232311 — LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. Aug 14, 2023
K231434 — DESS Dental Smart SolutionsTerrats Medical SL Aug 14, 2023
K230608 — SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty) , Ltd. Aug 14, 2023
K231018 — Yomi Robotic SystemNeocis, Inc. Aug 14, 2023
K223584 — Pre-Filled Normal Saline Flush SyringeAnhui Tianyang Pharmaceutical Co., Ltd. Aug 12, 2023
K230756 — TK Pre-Filled Normal Saline Flush SyringeAnhui Tiankang Medical Technology Co., Ltd. Aug 12, 2023
K230172 — Pulse OximeterBeijing Choice Electronic Technology Co., Ltd. Aug 12, 2023
K231823 — NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc. Aug 11, 2023
K230642 — Electronic Blood Pressure MonitorDongguan Kangweile Electronic Technology Co., Ltd. Aug 11, 2023
K223463 — Otsuka Digital Feedback Device-RWOtsuka America Pharmaceutical, Inc. Aug 11, 2023
K223856 — NuEra Tight RF FamilyBios S.R.L. Aug 11, 2023
K223519 — Carex Hybrid Personal LubricantKarex Industries Sdn. Bhd. Aug 11, 2023
K230420 — Dr. pen Microneedling SystemGuangzhou Ekai Electronic Technology Co., Ltd. Aug 11, 2023
K231696 — Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew UniversalPrevest Denpro Limited Aug 11, 2023
K230297 — PMT Expandable Cage (PMT EXP)Providence Medical Technology, Inc. Aug 11, 2023
← Previous Page 28 of 67 Next →