510(k) Clearances in 2023 — Page 67

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 67 of 67)
510(k) clearancesDetails
K223719 — Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc. Jan 11, 2023
K223181 — NuVasive Reline SystemNu Vasive, Incorporated Jan 11, 2023
K223000 — Artix BGInari Medical Jan 11, 2023
K223295 — Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500DFujifilm Corporaton Jan 11, 2023
K222799 — Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices Jan 10, 2023
K221090 — Metal Cannulated ScrewDouble Medical Technology, Inc. Jan 10, 2023
K211047 — CoCr HeadZimmer GmbH Jan 10, 2023
K222115 — ISAAC Neurovascular Navigation CatheterMicroVention, Inc. Jan 10, 2023
K223336 — Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation Jan 9, 2023
K222711 — HS186B ScooterSuzhou Master Machinery Manufacturing Co.,Ltd Jan 9, 2023
K222787 — Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000PChongqing Sunkingdom Medical Instrument Co., Ltd. Jan 9, 2023
K222789 — VADER® Pedicle System, G21 CementIcotec AG Jan 9, 2023
K223789 — 21HQ513DLg Electronics.Inc Jan 9, 2023
K211163 — Bone Cement Genta, Bone Cement HV, Bone Cement LVTecres S.P.A. Jan 9, 2023
K223200 — Curiteva Navigation SystemCuriteva, Inc. Jan 6, 2023
K222577 — TECHFIT Diagnostic ModelsTechfit Digital Surgery, Inc. Jan 6, 2023
K221260 — CSF-3Cardiacsense Jan 6, 2023
K203380 — Disposable Surgical Face MaskShandong Pop Jeans Intelligent Manufacturing Co., Ltd. Jan 6, 2023
K211812 — BLUEDIAMOND IMPLANT, Abutment ScrewMegagen Implant Co., Ltd. Jan 6, 2023
K223412 — LumiVy™ Lumbar IBF SystemVy Spine, LLC Jan 6, 2023
K223675 — WatchPAT ONE (WP1)Itamar Medical , Ltd. Jan 6, 2023
K213423 — T3 Platform softwareEtiometry, Inc. Jan 6, 2023
K223749 — U by Kotex® Click® Unscented Menstrual TamponsKimberly-Clark Corporation Jan 6, 2023
K222296 — ARTICUL/EZE Ceramic HeadsDepuy Ireland UC Jan 6, 2023
K213198 — Ax-Surgi Surgical HemostatAdvamedica, Inc. Jan 5, 2023
K221149 — U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation Jan 5, 2023
K221181 — Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. Jan 5, 2023
K221266 — Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc. Jan 5, 2023
K223671 — CONDUIT LLIF Straight InsertersEnztec Limited Jan 5, 2023
K223650 — REMEDY Stemmed Knee SpacerOsteoremedies, LLC Jan 5, 2023
K222483 — Surgical Face MaskHubei Woozon Healthcare Co., Ltd. Jan 4, 2023
K223685 — SmoothCool HR SystemJeisys Medical, Inc. Jan 4, 2023
K221693 — Elecsys Anti-HCV II (08837031190)Roche Diagnostics Jan 4, 2023
K221379 — Steriking LT-Blueline Pouches with TyvekWipak OY Jan 4, 2023
K223635 — Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot ViewerSienco, Inc. Jan 4, 2023
K222907 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl CitrateRmkh Glove (Cambodia) Co., Ltd. Jan 4, 2023
K222045 — Wearable Breast Pump (Model S1DW)Shenzhen TPH Technology Co., Ltd. Jan 4, 2023
K222221 — DEKA HELIXEl.En Electronic Engineering Spa Jan 4, 2023
K222182 — Radial Artery Compression TourniquetsBeijing Demax Medical Technology Co.,Ltd Jan 4, 2023
K221125 — SilentCloudAureliym GmbH Jan 4, 2023
K213263 — OnyxCephImage Instruments GmbH Jan 4, 2023
K223411 — Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Techology Co., Ltd. Jan 4, 2023
K222809 — Medical Disposable Face MasksAnqing Mayfield Medical Limited Jan 3, 2023
K223775 — EZ-STIK ElectrodesSouth Dakota Partners Jan 3, 2023
K223378 — 3.0T 16ch AIR AAGe Healthcare Coils (Usa Instruments, Inc.) Jan 3, 2023
K220847 — AETOS Shoulder SystemSmith & Nephew, Inc. Jan 3, 2023
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