510(k) Clearances in 2023 — Page 61

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 61 of 67)
510(k) clearancesDetails
K223056 — JAWS Nitinol Staple SystemParagon 28, Inc. Feb 16, 2023
K223478 — VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN PlazomicinbioMerieux, Inc. Feb 16, 2023
K221784 — Single-use Video Pancreaticobiliary Scope, PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd. Feb 16, 2023
K223766 — NUVISION™ NAV Ultrasound CatheterBiosense Webster, Inc. Feb 16, 2023
K223028 — uCT ATLAS Astound with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd. Feb 16, 2023
K222622 — Disposable Infusion Bag for Parenteral NutritionBeijing L&Z Medical Technology Development Co., Ltd. Feb 16, 2023
K223327 — Sterile Aesthetic Cannula and Hypodermic NeedleShanghai Kindly Enterprise Development Group Co., Ltd. Feb 16, 2023
K223770 — Sonopet 1Q 3 7cm 1Q LargeStryker Corporation Feb 16, 2023
K213844 — Surgical GownBayteks Teknik Tekstil San. VE Tic. A.S. Feb 16, 2023
K223046 — Xpert® FII & FVCepheid® Feb 15, 2023
K230131 — ReShape Calibration TubesReshape Lifesciences Feb 15, 2023
K222869 — Arm Blood Pressure MonitorAndon Health Co, Ltd. Feb 15, 2023
K230175 — Digital Radiography CXDI-CS01Canon, Inc. Feb 15, 2023
K223815 — ONE DROP Lancing DeviceStat Medical Devices Feb 15, 2023
K221874 — Altis Single Incision Sling SystemColoplast A/S Feb 15, 2023
K223022 — SC HONKYTONK PTCA Balloon Dilatation CatheterSino Medical Sciences Technology, Inc. Feb 15, 2023
K222389 — ZEUS SystemiRhythm Technologies, Inc. Feb 15, 2023
K223407 — Versana EssentialGE Medical Systems Ultrasound And Primary Care Diagnostics Feb 15, 2023
K222271 — Verisafe Safety sterile needlesPromisemed Hangzhou Meditech Co., Ltd. Feb 15, 2023
K213669 — LIGHTSCALPEL LS-4020Lightscalpel, Inc. Feb 15, 2023
K221523 — Tanning LampUnilam Co., Ltd. Feb 15, 2023
K223891 — Cobra Catheter SystemEndovascular Engineering Feb 15, 2023
K221490 — Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT Vertebral Body Replacement System, VLIFT-s Vertebral Body Replacement System, Ascential IBD PEEKc Spacer, Aero-AL Lumbar Cage System, Aero-LL Lumbar Cage System, Aero-C Cervical Cage System, AVS Aria PEEK Spacer, AVS Anchor-C Cervical Cage System, AVS Anchor-L SpacerStryker Spine Feb 14, 2023
K221468 — Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon Fixation Device, Citrespline™ and Citrelock™ ACL ImplantsAcuitive Technologies, Inc. Feb 14, 2023
K223225 — 8ch T/R Knee CoilShenzhen RF Tech Co., Ltd. Feb 14, 2023
K221672 — Creo Electrosurgical System with NP1 InstrumentCreo Medical, Ltd. Feb 14, 2023
K213757 — Endocem MTA Premixed RegularMaruchi Feb 14, 2023
K221527 — StitchKitOrigami Surgical Inc . Feb 14, 2023
K223174 — X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc. Feb 14, 2023
K223767 — Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance SystemStryker Leibinger GmbH & Co KG Feb 13, 2023
K222341 — Arrow 0.2 Micron Flat Filter, GVSArrow International, LLC Feb 13, 2023
K223859 — Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color Tested for Use with Chemotherapy Drugs and FentanylRhino Health, Inc. Feb 13, 2023
K222327 — Bloomlife MFM-ProBloom Technologies NV Feb 13, 2023
K223186 — Indigo® Aspiration System – Lightning Bolt Aspiration TubingPenumbra, Inc. Feb 13, 2023
K223656 — AmeriWater MediQA Reverse Osmosis System (MSP3HF)AmeriWater, LLC Feb 13, 2023
K230207 — ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Feb 13, 2023
K223761 — OIC Intramedullary Screw SystemOrthopaedic Implant Company Feb 13, 2023
K223779 — EMPOWR™ blade stemEncore Medical, LLC Feb 13, 2023
K230196 — syngo.via View&GO VA40ASiemens Healthcare GmbH Feb 13, 2023
K212635 — SofjecHwajin Medical Co., Ltd. Feb 13, 2023
K223263 — Prevena Plus 125 Therapy Unit3M Feb 13, 2023
K223370 — NeatNick Heel Safety LancetFacet Technologies, LLC Feb 13, 2023
K221875 — Sterilization Pouch and RollQianjiang Kingphar Medical Packaging & Printing Co., Ltd. Feb 13, 2023
K213030 — Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc. Feb 13, 2023
K223439 — SIGNA VictorGe Healthcare (Tianjin) Company Limited Feb 13, 2023
K223387 — V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. Feb 13, 2023
K213629 — SMILENu Eyne Co., Ltd. Feb 12, 2023
K213853 — RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing LargeSmith And Nephew Medical Limited Feb 10, 2023
K220435 — SEJONG Surgical Gown SoftSejong Healthcare Co., Ltd. Feb 10, 2023
K222513 — Glass CeramicsYilink (Tianjin) Biotechnology Co., Ltd. Feb 10, 2023
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