510(k) Clearances in 2022 — Page 23

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 23 of 65)
510(k) clearancesDetails
K222069 — Ez3D-i/E3Ewoosoft Co., Ltd. Sep 6, 2022
K220962 — ROTAPRO Rotational Atherectomy SystemBoston Scientific Corporation Sep 6, 2022
K221283 — Hammertoe Truss System (HTS)4Web Medical, Inc. Sep 6, 2022
K222048 — Spectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation Sep 6, 2022
K220251 — Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A. Sep 6, 2022
K211858 — TULSA-PRO SystemProfound Medical, Inc. Sep 6, 2022
K221636 — EMPHASYS Acetabular SystemDepuy Ireland UC Sep 6, 2022
K221929 — Smith+Nephew INTELLIO TabletSmith+Nephew Sep 6, 2022
K213868 — ASAHI Gladius Mongo18 PV ESAsahi Intecc Co., Ltd. Sep 6, 2022
K213960 — LiverMultiScan v5 (LMSv5)Perspectum Sep 6, 2022
K213864 — Bonebridge Osteosynthesis Plating SystemBonebridge AG Sep 2, 2022
K213287 — StageOne Knee Cement Spacer MoldsBiomet, Inc. Sep 2, 2022
K221414 — ENROUTE Enflate Transcarotid RX Balloon Dilatation CatheterSilk Road Medical, Inc. Sep 2, 2022
K213983 — Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily WearYung Sheng Optical Co., Ltd. Sep 2, 2022
K221957 — Savewo ClassicMASKSavewo Limited Sep 2, 2022
K203503 — Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC Sep 2, 2022
K221644 — Synthetic Bone PuttyVentris Medical Sep 2, 2022
K222426 — Perfetta Moderate Medical Face MaskPhu Bao Group Company Limited Sep 2, 2022
K221932 — Omni LegendGE Healthcare Sep 2, 2022
K213855 — Arrow Pressure Injectable Midline CatheterArrow International, LLC Subsidiary Of Teleflex Incorporated Sep 2, 2022
K221277 — Mygen M-3004 RF Generator M-3004RF Medical Co., Ltd. Sep 2, 2022
K211178 — DURAMESH Mesh SutureMsi Sep 2, 2022
K212222 — Soniquence Reusable 3 Button Fingerswitch WandSoniquence, LLC Sep 2, 2022
K221085 — LiNA OperaScope NeedleLina Medical Aps Sep 2, 2022
K222075 — CellFX SystemPulse Biosciences, Inc. Sep 2, 2022
K212189 — FibroLuxMulti Radiance Medical Sep 2, 2022
K221557 — Visera Hysterovideoscope Olympus HYF Type VOlympus Medical Systems Corporation Sep 2, 2022
K220531 — FOX 810, FOX 980A.R.C Laser GmbH Sep 1, 2022
K220997 — Wireless TENS/EMS, Bruno, AelaZmi Elecronics , Ltd. Sep 1, 2022
K221038 — Disposable Medical MasksHantech Medical Device Co., Ltd. Sep 1, 2022
K220104 — Knee+Pixee Medical Sep 1, 2022
K220563 — Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION SystemArthroCare Corporation Sep 1, 2022
K220177 — Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001KMagnus Medical, Inc. Sep 1, 2022
K201876 — Soteria Bed BarrierTrinity Guardion Sep 1, 2022
K221987 — Erchonia GVLErchonia Corporation Sep 1, 2022
K220579 — Hybrid C70Digimed Co., Ltd. Sep 1, 2022
K221241 — DrAid for Radiology v1Vinbrain Joint Stock Company Sep 1, 2022
K213513 — Vented Vial Adapter 20mmWest Pharma. Services IL, Ltd. Aug 31, 2022
K210935 — I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH Aug 31, 2022
K221745 — Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd. Aug 31, 2022
K221475 — MyClearALIGN Dental Aligner SystemKey Dental Technologies, LLC Aug 31, 2022
K220933 — QT Scanner 2000 Model AQt Imaging, Inc. Aug 31, 2022
K221255 — SimpliShade Bulk Fill, SimpliShade Bulk Fill FlowKerr Corporation Aug 31, 2022
K221467 — INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC Aug 31, 2022
K221040 — Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11)Jiangxi Aicare Medical Technology Co., Ltd. Aug 31, 2022
K221635 — IPL sapphire ice cooling hair remove deviceShenzhen Desida Technology Co., Ltd. Aug 31, 2022
K222387 — Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation Aug 31, 2022
K221955 — Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20Realcloud Imaging Inc. Dba Realcloud Imaging Aug 31, 2022
K221507 — Disposable Blood LancetSteriLance Medical (Suzhou), Inc. Aug 31, 2022
K222325 — 8ch Wrist CoilInvivo Corporation (Business Trade Name: Philips) Aug 31, 2022
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