510(k) Clearances in 2023 — Page 53

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 53 of 67)
510(k) clearancesDetails
K221320 — Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EXNidek Co., Ltd. Mar 30, 2023
K223853 — Medartis APTUS® Ulna PlatesMedartis AG Mar 30, 2023
K221872 — ITrack Advance Canaloplasty Microcatheter with Advanced Delivery SystemNova Eye Inc. (Business Name Nova Eye Medical) Mar 30, 2023
K223305 — Trevo NXT ProVue RetrieverStryker Neurovascular Mar 29, 2023
K212423 — EndoDrill® Model XBibbinstruments AB Mar 29, 2023
K222871 — Stethophone v1Sparrow Acoustics, Inc. Mar 29, 2023
K222485 — SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG LaserIds, Limited Mar 29, 2023
K222397 — KLS Martin Level One Rib Fixation SystemKLS-Martin L.P. Mar 29, 2023
K223916 — PUMA-G SystemCoaptech, Inc. Mar 29, 2023
K230527 — WishBone Medical Plate and Screw SystemWishbone Medical, Inc. Mar 29, 2023
K223915 — TactosetAnika Therapeutics, Inc. Mar 29, 2023
K213815 — SiJoin®T3Vgi Medical, Inc. Mar 29, 2023
K222312 — RayStation 12ARaySearch Laboratories AB (PUBL) Mar 29, 2023
K221984 — InterView XP; InterView FUSIONMediso Medical Imaging Systems, Lttd. Mar 29, 2023
DEN220030 — RemeOs™ Screw LAG SolidBioretec, Ltd. Mar 29, 2023
K230243 — ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas Mar 29, 2023
K223611 — Calibrate LTX Interbody SystemAlphatec Spine, Inc. Mar 29, 2023
K221995 — Gas InsufflatorSurgnova Healthcare Technologies (Zhejiang) Co., Ltd. Mar 28, 2023
K221938 — KLS Martin Pure Pectus SystemKLS Martin L.P. Mar 28, 2023
K230251 — Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)Stryker Sustainability Solutions Mar 28, 2023
K223625 — CapnoSpot™ Pneumothorax Decompression IndicatorPneumeric, Inc. Mar 28, 2023
K222174 — RadioLens v1.0Synapsica Mar 28, 2023
K222268 — Annalise Enterprise CXR Triage TraumaAnnalise-Ai Pty , Ltd. Mar 28, 2023
K222179 — Annalise Enterprise CXR Triage TraumaAnnalise-Ai Pty , Ltd. Mar 28, 2023
K230582 — SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900STERIS Corporation Mar 28, 2023
K221921 — DTX Studio Clinic 3.0Nobel Biocare AB Mar 28, 2023
K230026 — SQUALEImplanet, S.A. Mar 28, 2023
K213867 — Carestation 750/750cDatex-Ohmeda, Inc. Mar 28, 2023
K220226 — X-Y Lubricating JellyR&R Medical Corporation, Ltd. Mar 28, 2023
K230271 — ISOLIS CryoprobeVarian Medical Systems, Inc. Mar 28, 2023
K230255 — Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019Stryker Sustainability Solutions Mar 28, 2023
K222260 — Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L. Mar 28, 2023
K223928 — Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016KShenzhen Fansizhe Science And Technology Co., Ltd. Mar 28, 2023
K222146 — Disposable Endoscopic HemoclipJiangsu Vedkang Medical Science And Technology Co., Ltd. Mar 28, 2023
K223343 — MAGNETOM Amira; MAGNETOM SempraSiemens Medical Solutions USA, Inc. Mar 28, 2023
K222729 — Electrical Scooter, WT-T4QP2Wu’S Tech Co., Ltd. Mar 28, 2023
K222746 — Overjet Caries AssistOverjet, Inc. Mar 27, 2023
K223823 — Disposable Surgical Face MaskEfofex, Inc. Mar 27, 2023
K223882 — Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)Shenzhen Honpal Optoelectronic Technology Co., Ltd. Mar 27, 2023
K223192 — XT Stain/GlazeShenzhen Xiangtong Co., Ltd. Mar 27, 2023
K223365 — RODIN Palette Naturalizing KitBelport Company, Inc., Gingi-Pak Mar 27, 2023
K223581 — Solero Microwave Tissue Ablation (MTA) System and AccessoriesAngioDynamics, Inc. Mar 27, 2023
K200452 — Meril-BonewaxM/S. Meril Endo Surgery Private Limited. Mar 27, 2023
K230046 — Vinyl examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd. Mar 25, 2023
K220644 — Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy DrugsYty Industry (Manjung) Sdn Bhd Mar 25, 2023
K230461 — Quantra Hemostasis AnalyzerHemosonics, LLC Mar 24, 2023
K223803 — Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) SystemCanary Medical USA, LLC Mar 24, 2023
K222559 — BD BACTEC™ Myco/F Lytic Culture VialsBecton, Dickinson And Company Mar 24, 2023
K230797 — SmartMTA CapsuleSprig Oral Health Technologies, Inc. Mar 24, 2023
K223236 — Medline Surgical Face Mask and Medline Procedural Face MaskMedline Industries, LP Mar 24, 2023
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