510(k) Clearances in 2022 — Page 22

3,209 510(k) clearances total

Browse FDA 510(k) clearances granted in 2022. RegDataLab tracks 3,209 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2022 (page 22 of 65)
510(k) clearancesDetails
K221140 — P20 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp. Sep 13, 2022
K221417 — CLAROX plus (Model: VX-100)Vsi Co., Ltd. Sep 13, 2022
K213575 — Female IC (Not Finalized)Hollister Incorporated Sep 13, 2022
K214035 — LAITEST Medical Face MaskR&R Medical Corporation, Ltd. Sep 13, 2022
K221092 — Transcutaneous Electrical Nerve Stimulator Model: ST-304Shenzhen Future Electronic Co., Ltd. Sep 13, 2022
K213770 — SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG Sep 13, 2022
K220953 — ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC Sep 13, 2022
K214024 — SOFIA 88 CatheterMicroVention, Inc. Sep 12, 2022
K222512 — Integrity-SI Fusion SystemOsteoCentric Technologies Sep 12, 2022
K221450 — Phosphoric Acid Etching GelRizhao Huge Biomaterials Company, Ltd. Sep 12, 2022
K220986 — Aquilion Precision (TSX-304A/4) V10.10 with AiCECanon Medical Systems Corporation Sep 12, 2022
K220084 — Infrared Forehead ThermometerQingdao Yasee Medical Device Co., Ltd. Sep 12, 2022
K221533 — Plasma ShieldPlasmatica, Ltd. Sep 12, 2022
K221568 — KOLO Evolution XHD Series Ultrasound Diagnostic SystemKolo Medical (Suzhou) Co., Ltd. Sep 12, 2022
K221456 — Rapid ICHIschemaview, Inc. Sep 12, 2022
K222723 — AMBARINO High-ClassCreamed GmbH & Co. Produktions- Und Handels KG Sep 9, 2022
K221354 — Arthrex SutureTapeArthrex, Inc. Sep 9, 2022
K213244 — Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration)Prevest Denpro Limited Sep 9, 2022
K220659 — AUTOBAHN(R) EVO Femoral NailsGlobus Medical, Inc. Sep 9, 2022
K220002 — Dexus Prosthetics System (Model: MSL1, MSR1)Zhejiang Qiangnao Technology Co.,Ltd Sep 9, 2022
K221388 — NuVasive Reline Cervical SystemNu Vasive, Incorporated Sep 9, 2022
K222093 — V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization SystemSteris Sep 9, 2022
K222429 — Ellusa Reusable Bipolar CableEllusa, LLC Sep 9, 2022
K220944 — PointCore Surgical MaskPointcore, Inc. Sep 9, 2022
K220859 — Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black)Careglove Global Sdn. Bhd. Sep 9, 2022
K222440 — Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization TraysSteris Sep 9, 2022
K214028 — MICOR Lens Fragmentation SystemCarl Zeiss Meditec Cataract Technology, Inc. Sep 9, 2022
K222425 — Ellusa Reusable Neutral PlatesEllusa, LLC Sep 8, 2022
K213267 — Dynamis Pro FamilyFotona D.O.O. Sep 8, 2022
K220595 — NeoNavia Biopsy SystemNeodynamics AB Sep 8, 2022
K220143 — BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact LensShenzhen Dashicheng Optical Technology Co., Ltd. Sep 8, 2022
K211648 — Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDiazyme Laboratories, Inc. Sep 8, 2022
K222409 — CAPTIVATE® Compression ScrewsGlobus Medical, Inc. Sep 8, 2022
K221331 — Disposable Endoscope Valves SystemChangzhou Endoclean Medical Device Co., Ltd. Sep 8, 2022
K210973 — MammaPrint FFPE NGS KitAgendia, Inc. Sep 8, 2022
K213947 — Ultrasonic Endo Activation Device (Model:Actor I pro)Changzhou Bomedent Medical Technology Co.,Ltd Sep 8, 2022
K222076 — EFAI ChestSuite XR Pleural Effusion Assessment SystemEver Fortune.Ai, Co., Ltd. Sep 8, 2022
K220330 — Soundly Anti Snoring DeviceGreystone Ip, Ltd. Sep 8, 2022
K221684 — Osstem Abutment SystemOsstem Implant Co., Ltd. Sep 8, 2022
K213989 — Cranial EM SystemBrainlab AG Sep 8, 2022
K222020 — HD-550 Video Endoscope SystemSonoscape Medical Corp. Sep 8, 2022
K220783 — syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. Sep 7, 2022
K221731 — FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWireT.A.G. Medical Products Corporation, Ltd. Sep 7, 2022
K222110 — Mariner RDX SystemSeaSpine Orthopedics Corporation Sep 7, 2022
K220567 — Easi-Vue embolic microspheres SystemAbk Biomedical, Inc. Sep 7, 2022
K203594 — EyeCTesterNeuro-Eye Diagnostic Systems, LLC Sep 7, 2022
K220920 — Matreneu Percutaneous Balloon Compression KitShenzhen Shineyard Medical Device Co. , Ltd. Sep 7, 2022
K222034 — RightLance Blood Lancing SystemBeijing Ruicheng Medical Supplies Co., Ltd. Sep 7, 2022
K222111 — Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30GOwen Mumford, Ltd. Sep 7, 2022
K220112 — AXIOS Stent and Electrocautery-Enhanced Delivery SystemBoston Scientific Corporation Sep 7, 2022
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