510(k) Clearances in 2022 — Page 35

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 35 of 65)
510(k) clearancesDetails
K220848 — Venue FitGE Medical Systems Jun 27, 2022
K210947 — NavidentClaronav, Inc. Jun 27, 2022
K221834 — Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetCenters For Disease Control And Prevention Jun 24, 2022
K214123 — T-FIX® 3DSI Joint Fusion SystemCutting Edge Spine, LLC Jun 24, 2022
K220942 — 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)3M Company Jun 24, 2022
K213250 — Secret DuoIlooda Co,., Ltd. Jun 24, 2022
K213789 — Intelligence LaserCombYibin Yingtong Intelligent Technology Co., Ltd. Jun 24, 2022
K200715 — RoughRider Aurora Manual WheelchairRoughrider America, LLC Jun 24, 2022
K220300 — OTOPLANCascination AG Jun 24, 2022
K212043 — TRAUS ENDOSaeshin Precision Co., Ltd. Jun 24, 2022
K210852 — Noris Medical Dental Implants System - CorticalNoris Medical , Ltd. Jun 24, 2022
K220377 — Procedure MaskLittle Rapids Corporation Jun 24, 2022
K213114 — BentrioTM Allergy BlockerAltamira Therapeutics, Inc. Jun 24, 2022
K212741 — EZYPORFci (France Chirurgie Instrumentation) Sas Jun 24, 2022
K213439 — FlexBoardTM, EagleBoardTM, BreastBoard SXTMMacromedics BV Jun 24, 2022
K220575 — MAGNETOM Free.Max, MAGNETOM Free.StarSiemens Medical Solutions USA, Inc. Jun 24, 2022
K221524 — Sugita AVM Microclip ApplierMizuho America, Inc. Jun 24, 2022
K220801 — ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2Abbott Diagnostics Scarborough, Inc. Jun 24, 2022
K220756 — Introcan Safety 2 IV CatheterB.Braun Medical, Inc. Jun 23, 2022
K211173 — maxmorespine Bipolar ElectrodesHoogland Spine Products, GmbH Jun 23, 2022
K213194 — HD MediastinoscopeKarl Storz Endoscopy America, Inc. Jun 23, 2022
K221204 — Excipio SV Thrombectomy DeviceContego Medical, Inc. Jun 23, 2022
K213349 — Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. Jun 23, 2022
K220497 — CoLumboSmart Soft Healthcare AD Jun 23, 2022
K221511 — Axial3D Cloud Segmentation ServiceAxial Medical Printing Limited Jun 23, 2022
K220732 — Mural Perinatal SurveillanceGe Medical Systems Information Technologies, Inc. Jun 23, 2022
K220514 — bite away neomibeTec GmbH Jun 23, 2022
K213612 — SYLFIRM XVIOL Co., Ltd. Jun 23, 2022
K201788 — EDEN Spinal Fixation SystemJmt Co., Ltd. Jun 23, 2022
K213233 — EZYPRO ECG Recorder (Model: UG02)Sigknow Biomedical Co., Ltd. Jun 23, 2022
K220993 — Ultrasound System SONIMAGE MX1Konica Minolta, Inc. Jun 23, 2022
K220494 — BreathID Hp Lab System, BreathID Smart SystemMeridian Bioscience Israel , Ltd. Jun 23, 2022
K213338 — CORE-CLIPIncore Co., Ltd. Jun 23, 2022
K221188 — ZEPTO Precision Capsulotomy SystemCentricity Vision, Inc. Jun 23, 2022
K211877 — Klassic Knee SystemTotal Joint Orthopedics, Inc. Jun 22, 2022
K220413 — Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) SystemCanary Medical USA, LLC Jun 22, 2022
K220586 — Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament MeshSofradim Production Jun 22, 2022
K213283 — GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec Limited Jun 22, 2022
K221192 — Disposable Nitrile Powder-Free Examination GlovesShandong Maida Medical Technology Co., Ltd. Jun 22, 2022
K212665 — Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911)Huizhou Xiaoou Technology Co., Ltd. Jun 22, 2022
K221008 — HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)Shanghai Handy Medical Equipment Co., Ltd. Jun 22, 2022
K213682 — HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder RemoteEdwards Lifesciences, LLC Jun 22, 2022
K213274 — Qlicksmart BladeFlask UNIVERSALQlicksmart Pty , Ltd. Jun 22, 2022
K213739 — Nitrile Examination GlovesHangzhou Runheng Medical Co., Ltd. Jun 22, 2022
K213765 — Glidewell 3DP Denture Base ResinPrismatik Dentalcraft, Inc. Jun 22, 2022
K213230 — T3 Platform SoftwareEtiometry, Inc. Jun 22, 2022
K221185 — TC GlovesThanh Cong Pharmaceutical And Trading Company Limited Jun 22, 2022
K221482 — Esophageal TTS StentTaewoong Medical Co., Ltd. Jun 22, 2022
K213345 — Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbH Jun 22, 2022
K220800 — Venue GoGE Medical Systems Ultrasound And Primary Care Diagnostics Jun 21, 2022
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