510(k) Clearances

174,759 clearances total

K223912 — InterCollagen® GuideSigmagraft, Inc. Thu Aug 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230871 — EXTRON 5; EXTRON 7DRTECH Corporation Thu Aug 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223538 — Integrity ImplantAnika Therapeutics, Inc. Thu Aug 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222772 — Oral/Enteral Syringe with ENFit connectorAnhui Tiankang Medical Technology Co., Ltd. Thu Aug 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232126 — EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler AnvilCovidien Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223922 — SOMNUM (V.1.1.2.)Honeynaps Co., Ltd. Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230832 — Powdered Free Sterile Natural Rubber Latex Surgical GlovesThe Egyptian Company For Medical & Electronic Industries Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230581 — TOPA12 Portable X-ray UnitNeuf, Inc. Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230298 — Celsi MonitorHadleigh Health Technologies Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
DEN220073 — Revi SystemBluewind Medical , Ltd. Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231389 — Harvest Dental HD Gum StripHarvest Dental Products, LLC Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231087 — Guided Surgery KitImplant Direct Sybron Manufacturing, LLC Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222148 — HemoScreen Hematology AnalyzerPixcell Medical Technologies, Ltd. Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223709 — Kyphoplasty Balloon CatheterJiangsu Changmei Medtech Co., Ltd. Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230342 — Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd. Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232141 — CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head)Medtronic Sofamor Danek USA, Inc. Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230314 — Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)New Era Medicare Sdn. Bhd. Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223479 — AQUAbase nXB.Braun Medical, Inc. Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232116 — CoreLink Navigation InstrumentsCorelink, LLC Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231491 — TA™ Stapler and Loading Unit with DST Series™ TechnologyCovidien Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230577 — Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223874 — BAROguardParagonix Technologies Tue Aug 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231807 — primaLOK™ SP Interspinous Fusion SystemWenzel Spine, Inc. Tue Aug 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231829 — Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical Tue Aug 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231455 — Implant-One SystemImplant Logistics, Inc. Tue Aug 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231301 — Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics Tue Aug 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231094 — Annalise Enterprise CTB Triage-OHAnnalise-Ai Pty , Ltd. Tue Aug 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231838 — RxSight® Insertion Device (63002)Rxsight, Inc. Tue Aug 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231750 — MA012 Aluminum wheelchair, MS019 steel wheelchairSichuan Ast Medical Equipment Co., Ltd. Tue Aug 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232127 — 21HQ513D, 32HL512D, 31HN713D, 32HQ713DLg Electronics.Inc Tue Aug 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231583 — Route 92 Medical Full Length 054 Access SystemRoute 92 Medical, Inc. Tue Aug 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231054 — V-LaserWontech Co., Ltd. Mon Aug 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223660 — SaintViewInviz Corporation Mon Aug 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231208 — Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG Mon Aug 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231905 — Electro-Spec Steri-CapsElectro-Spec, Inc. Mon Aug 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230607 — SPICCA Cervical Fusion CagesSouthern Medical (Pty) , Ltd. Mon Aug 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231341 — Organic cotton tampon, Viscose tamponZhejiang Tianqing Manufacturing Technology Group Co., Ltd. Mon Aug 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230663 — DensityJeisys Medical, Inc. Mon Aug 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232311 — LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. Mon Aug 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231434 — DESS Dental Smart SolutionsTerrats Medical SL Mon Aug 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230608 — SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty) , Ltd. Mon Aug 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231018 — Yomi Robotic SystemNeocis, Inc. Mon Aug 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
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 Mon Aug 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231418 — ENDOGATOR™ Hybrid Irrigation TubingMedivators Mon Aug 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230172 — Pulse OximeterBeijing Choice Electronic Technology Co., Ltd. Sat Aug 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223584 — Pre-Filled Normal Saline Flush SyringeAnhui Tianyang Pharmaceutical Co., Ltd. Sat Aug 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230756 — TK Pre-Filled Normal Saline Flush SyringeAnhui Tiankang Medical Technology Co., Ltd. Sat Aug 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231696 — Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew UniversalPrevest Denpro Limited Fri Aug 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223463 — Otsuka Digital Feedback Device-RWOtsuka America Pharmaceutical, Inc. Fri Aug 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230642 — Electronic Blood Pressure MonitorDongguan Kangweile Electronic Technology Co., Ltd. Fri Aug 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
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