510(k) Clearances — Page 160

176,223 clearances total

Browse all FDA 510(k) medical device clearances. RegDataLab tracks 176,223 clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances (page 160 of 3,525)
ClearancesDetails
K232208 — Sectra Digital Pathology Module (Version 3.3)Sectra AB Apr 16, 2024
K233411 — Folysil Silicone CatheterColoplast Corp. Apr 15, 2024
K240205 — Ez Catch Auto; Ez Catch YR; Ez Catch TRVeol Medical Technologies Pvt , Ltd. Apr 15, 2024
K232926 — Novalung ultimate kit (US)Fresenius Medical Care Renal Therapies Group, LLC Apr 15, 2024
K223113 — Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit AbutmentsMedentika GmbH Apr 15, 2024
K232904 — Access OstaseBeckman Coulter Apr 15, 2024
K240884 — Glide (91000-GL-X)Infinite Biomedical Technologies, LLC Apr 15, 2024
K240773 — VisAble.IOTechsomed Apr 15, 2024
K232175 — XN Knee Prosthesis SystemBeijing Chunlizhengda Medical Instruments Co., Ltd. Apr 14, 2024
K240452 — Ceramic Femoral HeadMicroport Orthopedics, Inc. Apr 12, 2024
K232060 — TOSAMA Reusable ApplicatorTosama, D.O.O. Apr 12, 2024
K240238 — Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation Apr 12, 2024
K240703 — Fine Osteotomy™Bodycad Laboratories, Inc. Apr 12, 2024
K233034 — Mobility+ Enteral Feeding System OTCRockfield Medical Apr 12, 2024
K240419 — UltraThineer Zirconia Slurry (5Y-B)Boston Micro Fabrication Apr 12, 2024
K240686 — Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip CardHealgen Scientific,, LLC Apr 12, 2024
K233624 — HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream RxHangzhou Aichek Medical Technology Co., Ltd. Apr 12, 2024
K232587 — MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerShenzhen New Industries Biomedical Engineering Co., Ltd. Apr 12, 2024
K232200 — Disposable Injection NeedlesNingbo Xinwell Medical Technology Co., Ltd. Apr 12, 2024
K240418 — Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics Apr 12, 2024
K222766 — Disposable Extension SetShandong Ande Healthcare Apparatus Co., Ltd. Apr 12, 2024
K240109 — Medical electronic thermometer (FC01, FC02)Zhuzhou Goldenhot Medical Technology Co., Ltd. Apr 12, 2024
K232489 — VenusXLinatech, LLC Apr 12, 2024
K240571 — OASIS MRI SystemFujifilm Healthcare Corporation Apr 12, 2024
K232164 — Access NT-proBNPBeckman Coulter, Inc. Apr 12, 2024
K232608 — Duo Hands-free Breast PumpMedela, LLC Apr 12, 2024
K232999 — Lyric4 Hearing AidSonova AG Apr 11, 2024
K240720 — TiLink-P SI Joint Fusion SystemSurGenTec, LLC Apr 11, 2024
K202531 — Azer Scientific Universal Transport MediumAzer Scientific, Inc. Apr 11, 2024
K240719 — OC JuggerKnot Soft AnchorRiverpoint Medical Apr 11, 2024
K233698 — True Enhance DLGe Healthcare Japan Corporation Apr 11, 2024
K233757 — TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd. Apr 11, 2024
K221847 — Ni2 Implant SystemNewton Implant Systems, Inc. Apr 11, 2024
K233561 — 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))Topcon Corporation Apr 10, 2024
K240654 — SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test CassetteSafecare Biotech (Hangzhou) Co., Ltd. Apr 10, 2024
K233789 — 8Q10 Surclear Smoke Plume Evacuation SystemSurnic Corporation Apr 10, 2024
K234057 — NIRVANAEl.En S.P.A. Apr 10, 2024
K240089 — Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd. Apr 10, 2024
K232523 — Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%Mankind Pharma Limited Apr 10, 2024
K233509 — Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF SystemZavation Medical Products, LLC Apr 10, 2024
K233313 — Keikku Electronic stethoscopeLapsi Health Holding B.V. Apr 10, 2024
K232641 — Neorad Pacs (Neorad Pacs)Everrtech Software Pvt, Ltd. Apr 10, 2024
K240744 — uMR 680Shanghai United Imaging Healthcare Co., Ltd. Apr 10, 2024
K232409 — Electromagnetic Stimulation SystemsShanghai Apolo Medical Technology Co., Ltd. Apr 10, 2024
K240760 — CELERITY HP Indicator TapeSteris Apr 10, 2024
K232623 — Universal Endometrial Applicator Set (GM11009840)Varian Medical Systems, Inc. Apr 9, 2024
DEN230023 — Rho16 Bit, Inc. Apr 9, 2024
K232599 — TransForm McCarthy Mitral Annuloplasty Ring (TF)Genesee Biomedical, Inc. Apr 9, 2024
K233999 — GalaFLEX LITE ScaffoldTepha, Inc. Apr 9, 2024
K233263 — Disposable TrocarsHangzhou Kangji Medical Instrument Co., Ltd. Apr 9, 2024
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