510(k) Clearances in 2023 — Page 3

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 3 of 67)
510(k) clearancesDetails
K232286 — Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna InstrumentQuidel Corporation Dec 20, 2023
K231556 — SPECTRUM® GV Bone CementOsteoremedies, LLC Dec 20, 2023
K230545 — Inessa SystemTriple Jump Israel , Ltd. Dec 20, 2023
K232736 — Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card TestChemtron Biotech, Inc. Dec 20, 2023
K230840 — PMT Facet Fixation System, Lumbar (PMT FFS-LX)Providence Medical Technology, Inc. Dec 19, 2023
K231671 — IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468)Philips Medizin Systeme Boeblingen GmbH Dec 19, 2023
K233448 — Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter SetIntegra Lifesciences Production Corporation Dec 19, 2023
K222810 — TD-7301 Peak Flow meterGostar Co., Ltd. Dec 19, 2023
K233163 — ZENEX Implant System_ShortIzenimplant Co., Ltd. Dec 19, 2023
K232560 — Angled AbutmentArum Dentistry Co., Ltd. Dec 19, 2023
K221199 — Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode)Green Island International Tcm Group Limited Dec 19, 2023
K231526 — CORAIL Cemented Femoral StemDepuy Ireland UC Dec 19, 2023
K232458 — JETi™Hydrodynamic Thrombectomy SystemABBOTT MEDICAL Dec 19, 2023
K233551 — GORE® ACUSEAL Vascular GraftW. L. Gore & Associates, Inc. Dec 19, 2023
K233470 — DEKA LILYEl.En S.P.A. Dec 19, 2023
K233132 — PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)Primus Sterilizer Company, LLC Dec 19, 2023
K231587 — MAGNETOM Cima.XSiemens Medical Solutions USA, Inc. Dec 18, 2023
K231066 — CuratOR EX3242-FDEizo Corporation Dec 18, 2023
K232984 — Ion Endoluminal System (IF1000)Intuitive Surgical, Inc. Dec 18, 2023
K231929 — iQ-solutionsSydney Neuroimaging Analysis Centre Pty, Ltd. Dec 18, 2023
K222846 — AMT G-Tube Balloon Gastrostomy Feeding DeviceApplied Medical Technology, Inc. Dec 18, 2023
K232780 — CC-Clip® Implant SystemCc-Instruments, Inc. Dec 18, 2023
K232847 — SiOxD Wound MatrixSioxmed, LLC Dec 18, 2023
K231429 — S-Plant Dental Implant SystemIdis Co., Ltd. Dec 18, 2023
K222881 — Access hsTnIBeckman Coulter, Inc. Dec 18, 2023
K233815 — ClotTriever SheathInari Medical, Inc. Dec 18, 2023
K233691 — FlexCath Cross Transseptal SolutionAcutus Medical, Inc. Dec 17, 2023
K233536 — Air Compression Recovery SystemShenzhen Dongjilian Medical Tech Co., Ltd. Dec 16, 2023
K232095 — SeptiCyte RAPIDImmunexpress, Inc. Dec 15, 2023
K230926 — Ova+ (K-OVAP-USA)Tenscare, Ltd. Dec 15, 2023
K231447 — Double Internal Joint Stabilizer- ElbowSkeletal Dynamics, Inc. Dec 15, 2023
K233607 — MagnetOs Easypack PuttyKuros Biosciences B.V Dec 15, 2023
K232394 — Internal Locking Plate and Screw Fixation SystemChangzhou Geasure Medical Apparatus And Instruments Co., Ltd. Dec 15, 2023
K232130 — Medline ReNewal Reprocessed ViewFlex Xtra ICE CatheterSurgical Instrument Services And Savings, Inc. Dec 15, 2023
K232939 — IPL Hair Removal DeviceShenzhen Borria Technology Co., Ltd. Dec 15, 2023
K232887 — Invisalign Palatal Expander SystemAlign Technology, Inc. Dec 15, 2023
K233681 — ConFirm 20 Minute IncubatorSTERIS Corporation Dec 15, 2023
K233564 — FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)Fluoptics Sas (A Getinge Group Company) Dec 15, 2023
K232384 — Videa Dental AssistVideahealth, Inc. Dec 15, 2023
K233682 — VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATESTERIS Corporation Dec 15, 2023
K231478 — Digital Blood Pressure Monitor (Model: YB-800)Wenzhou Yosun Medical Technology Co.,Ltd Dec 15, 2023
K233668 — Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000)Eximo Medical, Ltd. Dec 15, 2023
K231700 — Ziehm Vision FDZiehm Imaging GmbH Dec 15, 2023
K230949 — ARTIS pheno (VE30A)Siemens Medical Solutions USA, Inc. Dec 15, 2023
K231825 — Panther TPSProwess, Inc. Dec 15, 2023
K232892 — Hp Detect™ Stool Antigen ELISABiomerica, Inc. Dec 15, 2023
K231160 — Cardio Q50, Cardio Q70Bionet Co., Ltd. Dec 15, 2023
K232267 — Precice Max SystemNuvasive Specialized Orthopedics, Incorporated Dec 15, 2023
K233182 — Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue)Zibo Kaiyue Mould Technology Co., Ltd. Dec 15, 2023
K230751 — EW10-EC02 Endoscopy Support ProgramFujifilm Corporation Dec 15, 2023
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