510(k) Clearances in 2023 — Page 55

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 55 of 67)
510(k) clearancesDetails
K222709 — Retraction, CWM-910T, APOLEX TiteChungwoo Co., Ltd. Mar 21, 2023
K223490 — FlightPlan for EmbolizationGE Medical Systems SCS Mar 21, 2023
K214070 — OviTex PRS (Long Term Resorbable)Tela Bio Mar 21, 2023
K220026 — Genomadix Cube CYP2C19 SystemGenomadix, Inc. Mar 21, 2023
K230561 — Syngo Carbon Space VA30ASiemens Healthcare GmbH Mar 21, 2023
K223043 — The Integrity Spine Core SystemIntegrity Spine Mar 20, 2023
K230163 — TENS and EMS Stimulation (OTC)Changsha Yuwen Medical Equipment Co., Ltd. Mar 20, 2023
K223245 — ColibríCopan Wasp Srl Mar 20, 2023
K230174 — TENS and EMS Stimulation (OTC)Changsha Yuwen Medical Equipment Co., Ltd. Mar 20, 2023
K222104 — Atellica® CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc. Mar 20, 2023
K222417 — Shina Safety NeedleShina Corporation Mar 20, 2023
K221996 — P-Cure Proton Beam Therapy SystemP-Cure, Ltd. Mar 20, 2023
K220725 — HPR45iF Care Systems USA, LLC Mar 20, 2023
K222828 — Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B, WEP010709B, WEP010304A, WEP010759A, WEP010709AWickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd Mar 20, 2023
K223875 — MOBINEURO Alita Intraoperative MRI SystemSino Canada Health Engineering Research Institute (Hefei) Mar 20, 2023
K221841 — EOlife®Archeon Mar 18, 2023
K221808 — InterOss CollagenSigmagraft, Inc. Mar 18, 2023
K220963 — Simplexa COVID-19 & Flu A/B DirectDiasorin Molecular, LLC Mar 17, 2023
K221782 — Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesMerit Medical Pte. , Ltd. Mar 17, 2023
K221965 — FemDx FalloViewFemdx Medsystems, Inc. Mar 17, 2023
K223613 — InThrill Thrombectomy SystemInari Medical, Inc. Mar 17, 2023
K222101 — PrismGraymatters Health , Ltd. Mar 17, 2023
K223418 — DeGen Impulse AM™ SystemDegen Medical Mar 17, 2023
K221119 — RCRP Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc. Mar 17, 2023
K221893 — KARL STORZ Bipolar Resectoscopes with HF CableKarl Storz Endoscopy America, Inc. Mar 17, 2023
K223878 — Aevumed RAPID Suture AnchorsAevumed, Inc. Mar 17, 2023
K221772 — NeuroRPMNew Touch Digital, Inc. Mar 17, 2023
K230441 — EMPOWR Stem Extender, 50mmEncore Medical, L.P Dba Enovis Mar 17, 2023
K230115 — Denture Base ResinAidite (Qinhuangdao) Technology Co., Ltd. Mar 17, 2023
K230141 — LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG Mar 17, 2023
K223162 — Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COTHealgen Scientific,, LLC Mar 17, 2023
K221758 — SMR Stemless AnatomicLima Corporate S.P.A. Mar 17, 2023
K230435 — Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc. Mar 17, 2023
K221544 — MagVenture TMS Atlas Neuro Navigation SystemTonica Elektronik A/S Mar 17, 2023
K223666 — Ablacath™ Mapping CatheterAblacon, Inc. Mar 17, 2023
K223073 — AlioAlio, Inc. Mar 17, 2023
K223443 — Viz AAAViz. Ai, Inc. Mar 17, 2023
K223154 — Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+Magstim Company, Ltd. Mar 16, 2023
K222839 — EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 SystemIntuitive Surgical, Inc. Mar 16, 2023
K222838 — iSyncBrain©-CiMediSync, Inc. Mar 16, 2023
K220673 — Sterile Silver Alginate Wound DressingQingdao Bright Moon Biomedical Materials Co., Ltd. Mar 16, 2023
K223095 — Senhance Surgical SystemAsensus Surgical, Inc. Mar 16, 2023
K223828 — BENCOX Delta Option HeadsCorentec Co., Ltd. Mar 16, 2023
K222619 — EnsmileEnsmile Pvt, Ltd. Mar 16, 2023
K223084 — MilkMate Breast PumpMilkmate Products, Inc. Mar 16, 2023
K223393 — Electric WheelchairShanghai Bangbang Robotics Co., Ltd. Mar 16, 2023
K222813 — Nitrile Examination GlovesEcoglove Medical Manufacturing Company Limited Mar 16, 2023
K230404 — BIOFIRE FILMARRAY Gastrointestinal (GI) PanelBiofire Diagnostics, LLC Mar 16, 2023
K230124 — LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)Light Tree Ventures Europe B.V. Mar 15, 2023
K223102 — Tegamen Nitrile Examination GlovesM/S Tegamen Safety Products Private Limited Mar 15, 2023
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