510(k) Clearances in 2022 — Page 40

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 40 of 65)
510(k) clearancesDetails
K212873 — Aspire CristalleFujifilm Corporation May 27, 2022
K220610 — SOLO-LAurora Spine, Inc. May 27, 2022
K220146 — VisARNovarad Corporation May 27, 2022
K220902 — Navagio Lumbar CageKalitec Medical, LLC May 27, 2022
K212669 — Single Use HemoclipZhejiang Chuangxiang Medical Technology Co., Ltd. May 27, 2022
K220593 — Spine Guidance Software, Stryker Q Guidance SystemStryker Leibinger GmbH & Co KG May 27, 2022
K212268 — FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXTFMD Co., Ltd. May 27, 2022
K213698 — CoLink PCR Plating SystemIn2Bones USA, LLC May 27, 2022
K220557 — MoistureMeterD Compact, LymphScannerDelfin Technologies, Ltd. May 27, 2022
K220889 — Senhance Surgical SystemAsensus Surgical, Inc. May 27, 2022
K212413 — I-MotionI-Motion Group Global Iberica S.L. May 26, 2022
K220195 — iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc. May 26, 2022
K212629 — PP Care Nitrile Examination GlovesEg Group Product And Services Co., Ltd. May 26, 2022
K220249 — Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue)Grand Work Plastic Products Co., Ltd. May 26, 2022
K213027 — Laser Hair Growth CombKam Yuen Plastic Products , Ltd. May 26, 2022
K212644 — Aura StormInvictus Lighting May 26, 2022
K220641 — Barrigel Injectable GelPalette Life Sciences May 26, 2022
K220355 — Astroglide Ultra Gentle GelBiofilm, Inc. May 26, 2022
K220597 — Disposable Surgical Face Mask (FM-34EE,FM-44EE)Qingdao Bestex Rubber & Plastic Products Co., Ltd. May 26, 2022
K214074 — Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy DrugsHartalega NGC Sdn. Bhd. May 26, 2022
K213221 — AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbH May 26, 2022
K212132 — FreeStyle Libre 3 Continuous Glucose Monitoring SystemAbbott Diabetes Care, Inc. May 26, 2022
K210633 — Amylase2Abbott Ireland Diagnostics Division May 26, 2022
K213171 — Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)Meditrina, Inc. May 26, 2022
K220545 — Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy DrugsHl Rubber Industries Sdn Bhd May 26, 2022
K220596 — Wearable Breast Pump (Model S9)Shenzhen TPH Technology Co., Ltd. May 26, 2022
K211779 — ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine.Chip Ideas Electronics S.L. May 26, 2022
K213996 — FreeStyle Libre 3 Continuous Glucose Monitoring SystemAbbott Diabetes Care, Inc. May 26, 2022
K220416 — SwiftMRAirs Medical, Inc. May 25, 2022
K213039 — Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd. May 25, 2022
K214046 — 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight CableStryker May 25, 2022
K211652 — Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation May 25, 2022
K220065 — Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., Ltd. May 25, 2022
K203661 — CRYO Arctic, CRYO PenguinCryoscience North America, Inc. May 25, 2022
K220083 — LDV((Low Dead Volume )SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. May 25, 2022
K220481 — Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)Stryker Sustainability Solutions May 25, 2022
K220578 — Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)Bozhou Rongjian Medical Appliance Co., Ltd. May 25, 2022
K220350 — KardiaMobile 6LAliveCor, Inc. May 25, 2022
K210748 — Well-life TM Pen Needles, Well-life TM Safety Pen NeedlesW. L. Med Co., Ltd. May 25, 2022
K221180 — Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc. May 25, 2022
K210655 — Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterInnovative Health, LLC May 25, 2022
K220200 — Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd. May 25, 2022
K202920 — OptiCompPac-Dent, Inc. May 25, 2022
K220793 — InnoVoyce Laser FiberInnovoyce, LLC May 25, 2022
K221244 — CD Horizon™ Spinal SystemMedtronic May 25, 2022
K213485 — Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25EShenzhen AOJ Medical Technology Co., Ltd. May 25, 2022
K211953 — Disposable Sterilized Latex Surgical GlovesJiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. May 25, 2022
K201393 — restor3d MTP ImplantRestor3D, Inc. May 25, 2022
K210614 — BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd. May 24, 2022
K220952 — MY01 Continuous Compartmental Pressure MonitorMY01, Inc. May 24, 2022
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