510(k) Clearances in 2023 — Page 32

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 32 of 67)
510(k) clearancesDetails
K231221 — MDx-Chex for BC-GPStreck Jul 27, 2023
K231038 — Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC Jul 26, 2023
K231787 — ecoFIX®Science & Bio Materials (S.B.M.) Sas Jul 26, 2023
K222874 — CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics , Ltd. Jul 26, 2023
K220765 — HS Fiber CerclageRiverpoint Medical, LLC Jul 26, 2023
K231922 — DEPUY SYNTHES MAXFRAME AUTOSTRUT SystemDePuy Synthes Jul 26, 2023
K231572 — uMI PanoramaShanghai United Imaging Healthcare Co., Ltd. Jul 26, 2023
K222994 — Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33BShenzhen AOJ Medical Technology Co., Ltd. Jul 26, 2023
K231172 — ApolloKneeCorin U.S.A. Limited Jul 26, 2023
K231900 — A-TAP (previously called Arthrotap)Elcam Medical Acal Jul 25, 2023
K231924 — EZ-IO Intraosseous Vascular Access SystemTeleflex Medical Jul 25, 2023
K230540 — Patient Specific Planning Solution™ 3D Bone ModelsBiomet Manufacturing Corp Jul 25, 2023
K231878 — Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101STERIS Corporation Jul 25, 2023
K230365 — Sonio DetectSonio Jul 25, 2023
K221605 — Emit® II Plus Buprenorphine AssaySiemens Healthcare Diagnostics, Inc. Jul 25, 2023
K231621 — Reprocessed ViewFlex Xtra ICE Catheter (D087031)Stryker Sustainability Solutions Jul 25, 2023
K230913 — ANDIImeka Solutions, Inc. Jul 25, 2023
K230576 — IDENTIFYVarian Medical Systems, Inc. Jul 25, 2023
K230730 — ApyxEscala Medical Jul 25, 2023
K231275 — Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc. Jul 25, 2023
K213536 — DEKA ACE Pump SystemDeka Research And Development Jul 25, 2023
K222438 — A-LYTE® Integrated Multisensor (IMT Na K Cl)Siemens Healthcare Diagnostics, Inc. Jul 25, 2023
K223473 — ME-APDS™; MAGENTIQ-COLO™Magentiq Eye, Ltd. Jul 25, 2023
K230455 — Enamel Coating ResinRizhao Huge Biomaterials Company, Ltd. Jul 25, 2023
K231577 — MOBILETT ImpactSiemens Medical Solutions Jul 25, 2023
K230333 — Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)Kettenbach GmbH & Co. KG Jul 24, 2023
K223752 — Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and FentanylCentral Medicare Sdn Bhd Jul 24, 2023
K231523 — EsCom250Spident Co., Ltd. Jul 24, 2023
K223322 — Argus Cognitive ReVISION SoftwareArgus Cognitive, Inc. Jul 24, 2023
K223347 — UltraSight AI GuidanceUltrasight, Inc. Jul 24, 2023
K230931 — AtlanDrägerwerk AG Co. Kgaa Jul 23, 2023
K230560 — enspire 300 Series Automated Endoscope Reprocessor SystemSTERIS Corporation Jul 21, 2023
K231848 — Triever20 Curve (21-201)Inari Medical, Inc. Jul 21, 2023
K223637 — Elecsys proBNP II, Elecsys proBNP II STATRoche Diagnostics Jul 21, 2023
K230150 — OptimMRIRebrain, Sas Jul 21, 2023
K211218 — BD Alaris System with Guardrails Suite MX v12.1.2Carefusion 303, Inc. Jul 21, 2023
K231862 — TruDi® Navigation System V3 (FG-2000-00)Acclarent, Inc. Jul 21, 2023
K223499 — Three Way Stop CockM/S Romsons International Jul 21, 2023
K221319 — BD Alaris™ Pump Epidural Infusion SetCare Fusion Jul 21, 2023
K231516 — INHANCE™ Shoulder System, Sterile Single Use InstrumentationDepuy Ireland UC Jul 21, 2023
K223316 — Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement SystemConformis, Inc. Jul 21, 2023
K223769 — NextAR™ Spine PlatformMedacta International S.A. Jul 21, 2023
K221327 — BD Alaris™ Pump Infusion SetsCare Fusion Jul 21, 2023
K231474 — Erchonia Violet ZERONA® Z6 OTCErchonia Corporation Jul 21, 2023
K231173 — Irregular Rhythm Notification Feature (IRNF)Apple, Inc. Jul 21, 2023
K223037 — Infrared Thermometer, Model: IR8807Shen Zhen Rong Feng Technology Co., Ltd. Jul 21, 2023
K231483 — MySpine Unilateral GuidesMedacta International S.A. Jul 21, 2023
K223288 — Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRIBrainlab AG Jul 21, 2023
K231021 — KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric AcidKimberly-Clark Corporation Jul 21, 2023
K223189 — Firefighter™ NC Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd. Jul 21, 2023
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