510(k) Clearances in 2023 — Page 33

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 33 of 67)
510(k) clearancesDetails
K231161 — 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush SyringeBecton, Dickinson And Company Jul 21, 2023
K231861 — EndoflipTM 300 SystemCovidien, LLC Jul 21, 2023
K223317 — Alkaline Phosphatase2Abbott Ireland Diagnostics Division Jul 21, 2023
K222920 — Oxygen concentratorZhengzhou Olive Electronic Technology Co., Ltd. Jul 20, 2023
K223834 — AccuCheckManteia Technologies Co., Ltd. Jul 20, 2023
K231103 — ROSA ONE Brain ApplicationMedtech S.A.S Jul 20, 2023
K230039 — uOmnispaceShanghai United Imaging Healthcare Co., Ltd. Jul 20, 2023
K231799 — INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC Jul 20, 2023
K231840 — CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. Jul 20, 2023
K231790 — The InMode System with the Morpheus8 ApplicatorsInMode , Ltd. Jul 20, 2023
K213098 — Panther 5Origin Medical Devices Jul 20, 2023
K220977 — ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerBeckman Coulter Laboratory Systems (Suzhou) Co., Ltd. Jul 20, 2023
K223301 — ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC Jul 20, 2023
K231945 — VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure KitsAngioDynamics, Inc. Jul 20, 2023
K231808 — QUASAR Standalone ACIF SystemGS Medical Co., Ltd. Jul 20, 2023
K223484 — IGAR System (1001.A)Insight Medbotics, Inc. Jul 20, 2023
K230875 — Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance ClaimsCentral Medicare Sdn Bhd Jul 20, 2023
K230377 — CROSSLEAD Penetration Peripheral Guide WireAsahi Intecc Co., Ltd. Jul 20, 2023
K230787 — Oscar 15 & Oscar 15iGenoray Co., Ltd. Jul 20, 2023
K230037 — BACK 3Swims America Corp Jul 19, 2023
K231157 — syngo.CT Lung CAD (Version VD30)Siemens Healthcare GmbH Jul 19, 2023
K231292 — TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus SystemBonebridge AG Jul 19, 2023
K210801 — AXINON® LDL-p Test SystemNumares AG Jul 19, 2023
K231796 — Grreen X 12 (Model: PHT-75CHS)VATECH Co., Ltd. Jul 19, 2023
DEN220047 — Galen ES Cooperative Surgical Assistant Platform, Galen ESGalen Robotics Jul 19, 2023
K231839 — CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd. Jul 19, 2023
K231472 — Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT)Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. Jul 19, 2023
K223151 — Nu-beca Transcutaneous Electrical Nerve StimulationNu-Beca & Maxcellent Co. Jul 19, 2023
K231448 — TANDEM Hip SystemSmith & Nephew, Inc. Jul 19, 2023
K231410 — RenaPure Endotoxin Retentive FilterEvoqua Water Technologies, LLC Jul 19, 2023
K231437 — LF900Daesung Maref Co., Ltd. Jul 19, 2023
K213100 — FMT Reusable Temperature ProbesMetko Medikal VE Ttbbi Cihazlar D1S Ticaret Ltd. Sti Jul 18, 2023
K230716 — Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc. Jul 18, 2023
K223339 — Bone Chamber ImplantMegagen Implant Co., Ltd. Jul 18, 2023
K230945 — Forma Medical Headless Compression ScrewForma Medical, Inc. Jul 18, 2023
K221107 — TRUSTRgorithm Korea Jul 18, 2023
K222925 — Hypodermic Syringes & NeedleLifelong Meditech Private Limited Jul 18, 2023
K211143 — Pulse OximeterShenzhen Brav Electronic Technologies Co., Ltd. Jul 17, 2023
K231441 — ARIX Ankle SystemJeil Medical Corporation Jul 17, 2023
K230395 — Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)Durio Ppe Sdn Bhd Jul 17, 2023
K230407 — FloNavi Open Field Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc. Jul 17, 2023
K213953 — BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum TubesBecton, Dickinson And Company Jul 17, 2023
K230087 — “POINT” Kinguide Agile Hybrid Navigation SystemPoint Robotics MedTech, Inc. Jul 17, 2023
K222683 — Fibroid Mapping Reviewer Application (FMRA)Nesa Medtech Private Limited Jul 17, 2023
K230077 — LaserMENeauvia North America Jul 17, 2023
K230558 — Revital-Ox PAA High Level Disinfectant Chemical IndicatorSTERIS Corporation Jul 17, 2023
K231456 — Avitus® DragonWing Large Volume Autograft Delivery SystemAvitus Orthopaedics, Inc. Jul 17, 2023
K223252 — TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX PatellasExactech, Inc. Jul 17, 2023
K230846 — iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc. Jul 17, 2023
K230257 — Arthrex Intramedullary NailsArthrex, Inc. Jul 17, 2023
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