510(k) Clearances in 2023 — Page 30

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 30 of 67)
510(k) clearancesDetails
K223476 — V-PRO maX 2 Low Temperature Sterilization SystemSTERIS Corporation Aug 7, 2023
K230376 — Reprocessed Agilis NxT Steerable IntroducerInnovative Health, LLC Aug 7, 2023
K230733 — Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG Aug 5, 2023
K220031 — Alinity h-series SystemAbbott Laboratories Aug 4, 2023
K232005 — HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid)Smith & Nephew, Inc. Aug 4, 2023
K230126 — Dentis s-Clean Regular AbutmentDentis Co., Ltd. Aug 4, 2023
K230672 — Annabella Breast PumpAnnabella , Ltd. Aug 4, 2023
K231333 — STRETTO™ Cable SystemGlobus Medical, Inc. Aug 4, 2023
K223507 — CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE)Good Doctors Co., Ltd. Aug 4, 2023
K231370 — Dewin Blastocyst Medium (with HSA and without HSA)Donnevie Medical Technology (Shanghai) Co. , Ltd. Aug 4, 2023
K223673 — Surgeon Controlled ArmLevita Magnetics International Corp Aug 4, 2023
K222635 — Premier Resolution SystemTrinity Biotech (Primus Corporation, Dba Trinity Biotech) Aug 4, 2023
K223787 — ECGenius SystemCath Vision Aps Aug 4, 2023
K223431 — Citric Complete Liquid Citric Acid ConcentrateNipro Renal Solutions USA, Corp. Aug 4, 2023
K231404 — T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open ButtonHealthium Medtech Limited Aug 4, 2023
K221138 — Titus Titanium Cervical by SAGICOSagico VA USA, LLC Aug 4, 2023
K232010 — iTEMPSHIELDAion Biosystems, Inc. Aug 4, 2023
K231400 — Bladeless Trocar – Artemis Lap CannulaT.A.G. Medical Products Corporation, Ltd. Aug 4, 2023
K232006 — LEGACY® IPCIg Technology, Ltd. Aug 4, 2023
K231458 — Extremity StapleRestor3D Aug 3, 2023
K231654 — NorthStar OCT SystemSeaspine, Inc. Aug 3, 2023
K231831 — TiLink-L Joint Fusion SystemSurgentec Aug 3, 2023
K232132 — LifeSPARC SystemCardiacassist, Inc. Aug 3, 2023
K223551 — Sterile Water for Inhalation in 1L Flexoval ® bottles.Hometa, Inc. Aug 3, 2023
K223133 — VisiRad XRImidex, Inc. Aug 3, 2023
K223542 — TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH Aug 3, 2023
K223122 — MENIX®; MENIX® DUOS.B.M. Sas (Science & Bio Materials) Aug 3, 2023
K230380 — Surgical Face Masks, Model: EFMDS-L50Pn BLUIris USA Aug 3, 2023
K232058 — YosemiteView 4343W/YosemiteView 3643WCareray Digital Medical Technology Co., Ltd. Aug 3, 2023
DEN230003 — Viz HCMViz. Ai, Inc. Aug 3, 2023
K232015 — ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)Atmos Medizintechnik GmbH & Co. KG Aug 3, 2023
K231548 — Medical Diode Laser, Model S1ProWuhan Pioon Technology Co., Ltd. Aug 3, 2023
K221894 — Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc. Aug 3, 2023
K230419 — Sequel Tampon with Plastic ApplicatorTampro, Inc. Aug 3, 2023
K231174 — BPBIO750Inbody Co., Ltd. Aug 2, 2023
K231942 — Mineral Collagen Composite Bioactive Extra MoldableCollagen Matrix, Inc. Aug 2, 2023
K223553 — Spine Planning (2.0), Elements Spine Planning, Elements Planning SpineBrainlab AG Aug 2, 2023
K230748 — Disposable Ureteral Access SheathYoucare Technology Co.,Ltd. (Wuhan) Aug 2, 2023
K230613 — SKEEPERSmartsound Corporation Aug 2, 2023
K231344 — ActivSight Intraoperative Imaging SystemActiv Surgical, Inc. Aug 2, 2023
K231126 — Eblator DeviceE Surgical, LLC Aug 2, 2023
K223821 — Self-Cath Closed SystemColoplast Aug 2, 2023
K223114 — Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGm Dos Reis Industria E Comerico Ltda. Aug 2, 2023
K223689 — Disposable Needle Guides and GridsAdvance Medical Designs, Inc. Aug 2, 2023
K231593 — Sapphire X3 Anterior Cervical Plate SystemSpinal Elements, Inc. Aug 2, 2023
K232030 — Ingenia Elition R5.7.1 SP4 MR SystemsPhilips Medical Systems Nederland B.V. Aug 2, 2023
K221114 — Immunoglobulin G (IgG)Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. Aug 2, 2023
K231286 — Chemfort® Catheter AdaptorSimplivia Healthcare , Ltd. Aug 2, 2023
K231278 — Knotless Suture AnchorRiverpoint Medical, LLC Aug 1, 2023
K231602 — Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid TubingGa Health Company Limited Aug 1, 2023
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