510(k) Clearances in 2023 — Page 37

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 37 of 67)
510(k) clearancesDetails
K230859 — Aneroid SphygmomanometerWenzhou Kangshun Medical Devices Co.,Ltd Jun 28, 2023
K231232 — Curiteva Laminoplasty SystemCuriteva, Inc. Jun 28, 2023
K213652 — Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)Cresilon, Inc. Jun 28, 2023
K210924 — e-Celsius Medical SystemBodycap Jun 28, 2023
K220198 — Medi Lift PLUSYa-Man, Ltd. Jun 28, 2023
K230075 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5KMicrolife Intellectual Property GmbH Jun 28, 2023
K223722 — MIO Blood Glucose Monitoring SystemMio Labs, Inc. Jun 28, 2023
K223100 — Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)Medline Industries, Inc. Jun 27, 2023
K231636 — LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.L&K BIOMED Co., Ltd. Jun 27, 2023
K222492 — Hope&Her Vaginal DilatorsLujena, Inc. Jun 27, 2023
K230706 — EMBOLD™ Soft Detachable Coil SystemBoston Scientific Corporation Jun 27, 2023
K231219 — NobelZygoma PureSet™ TrayNobel Biocare Services AG Jun 27, 2023
K213046 — AceConnex Pre-Sutured FasciaAllosource Jun 27, 2023
K230876 — RI.KNEE Adjustable Tibia Cut GuideEnztec Limited Jun 27, 2023
K231124 — Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G)Owen Mumford, Ltd. Jun 27, 2023
K230861 — VADER® Pedicle System Navigated InstrumentsIcotec AG Jun 27, 2023
K223138 — AB1 Electrosurgical Instrument, Creo Electrosurgical SystemCreo Medical, Ltd. Jun 26, 2023
K231215 — IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008SZhongshan Qizhe Technology Co., Ltd. Jun 26, 2023
K230492 — Avitus® Precision Autograft Delivery SystemAvitus Orthopaedics, Inc. Jun 26, 2023
K222378 — VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL)bioMerieux, Inc. Jun 26, 2023
K223143 — SAGICO Spinal SystemSagico VA USA, LLC Jun 26, 2023
K230867 — Bone Bolt SystemUniversity Of Utah, Department Of Orthopaedics Jun 26, 2023
K221488 — Z7 Zirconia Implant SystemZ7, LLC Jun 26, 2023
K230914 — ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146)ArthroCare Corporation Jun 26, 2023
K222142 — BR SLA Type Implant SystemBiotem Co., Ltd. Jun 24, 2023
K231505 — GORE® ACUSEAL Vascular GraftW. L. Gore & Associates, Inc. Jun 23, 2023
K223638 — Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A. Jun 23, 2023
K231117 — neXus Ultrasonic Surgical Aspirator SystemMisonix, LLC, A Bioventus Company Jun 23, 2023
K223187 — HemosIL Liquid Anti-XaInstrumentation Laboratory CO Jun 23, 2023
K231185 — MapRTVision Rt, Ltd. Jun 23, 2023
K230276 — TECHFIT DISRP® SystemTechfit Digital Surgery Jun 23, 2023
K231153 — Neuhat Hair Growth System; ibeauty.com Laser CapNature, Inc.Redible, Inc. Jun 23, 2023
K223048 — Medisystem PacsMedilab Manutencao E Sitemas Ltda Jun 23, 2023
K222323 — Black DiamondElevate Oral Care, LLC Jun 23, 2023
K230160 — VINNO G86,VINNO G86E,VINNO G65,VINNO G65P,VINNO G65E,VINNO G65D,VINNO M86, VINNO M86E,VINNO G90,VINNO G90EVinno Technology (Suzhou) Co.,Ltd Jun 23, 2023
K230518 — HydraDose Vaginal SuppositoriesMD Labs, LLC Jun 23, 2023
K230369 — EUROPA™ Navigated InstrumentsMiRus, LLC Jun 23, 2023
K221827 — Mais Central Venous CatheterSaudi Mais Co. For Medical Products Jun 23, 2023
K223019 — sam 2.0 Long Ultrasound DeviceZetrOZ Systems, LLC Jun 23, 2023
K223159 — Radixact Treatment Delivery SystemAccuray Incorporated Jun 23, 2023
K231532 — ActiGraph LEAP activity monitor (ActiGraph LEAP)Actigraph, LLC Jun 23, 2023
K222982 — Virtus Metabolic MonitorVirtus Technology Aps Jun 23, 2023
K223013 — AccurECG Analysis SystemAccurkardia, Inc. Jun 23, 2023
K222969 — FERTI-LILY Conception CupRosesta Medical BV Jun 23, 2023
K221411 — Surflo Winged Infusion SetTerumo Medical Products (Hangzhou) Co., Ltd. Jun 23, 2023
K222592 — AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P. Jun 23, 2023
K230036 — Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )Rti Surgical, Inc. Jun 23, 2023
K230410 — DD medical polymers (PMMA)Dental Direkt GmbH Jun 23, 2023
K220955 — Hudson RCI Variable concentration Large Volume Nebulizer (1770)Medline Industires, Inc. Jun 23, 2023
K230359 — KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-Karl Storz Endoscopy America, Inc. Jun 23, 2023
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