510(k) Clearances in 2022 — Page 31

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 31 of 65)
510(k) clearancesDetails
K220956 — Libby Echo:PrioDyad Medical, Inc. Jul 20, 2022
K221794 — Vario-Cup SystemWaldemar Link GmbH & Co. KG Jul 20, 2022
K221037 — TruDi Shaver BladeAcclarent, Inc. Jul 20, 2022
K220161 — Biofeedback Nerve and Muscle StimulatorShenzhen Konmed Technology Co., Ltd. Jul 20, 2022
K220777 — Surgical face maskHubei Qianjiang Kingphar Medical Material Co., Ltd. Jul 19, 2022
K222037 — Selectra Lead Implantation SystemBiotronik, Inc. Jul 19, 2022
K213761 — Joule diVa SystemSciton, Inc Jul 19, 2022
K213409 — ZEUS System (Zio Watch)iRhythm Technologies, Inc. Jul 19, 2022
K220943 — Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test ClaimEco Medi Glove Sdn. Bhd. Jul 19, 2022
K213435 — MAGIC Flow-Dependent MicrocatheterBalt USA, LLC Jul 19, 2022
K220815 — BrainInsightHyperfine, Inc. Jul 19, 2022
K212215 — Tiche PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd. Jul 19, 2022
K221151 — Beauty LED Mask, Model: KFB265Hunan Guangye Biotechnology Co., Ltd. Jul 19, 2022
K221516 — ARTIS icono (Ceiling Configuration)Siemens Medical Solutions USA, Inc. Jul 19, 2022
K213357 — Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse MonitorVerily Life Sciences, LLC Jul 19, 2022
K212614 — Ultrasonic Scalpel SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd. Jul 18, 2022
K221148 — Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC Jul 18, 2022
K221147 — Vivid T8, Vivid T9GE Medical Systems Ultrasound And Primary Care Diagnostics Jul 18, 2022
K221803 — PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.Sedecal., Sa. Jul 18, 2022
K212509 — OSSIX BreezeDatum Dental, Ltd. Jul 18, 2022
K211720 — Planmed Clarity 2D, Planmed Clarify SPlanmed OY Jul 18, 2022
K210731 — KLS Martin Individual Patient SolutionsKLS-Martin L.P. Jul 18, 2022
K213955 — 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrubBecton, Dickinson And Company Jul 16, 2022
K221229 — Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination GlovesZibo Blue Sail Health Technology Co., Ltd. Jul 16, 2022
K221814 — OK HandpieceJaintek Co.,Ltd Jul 15, 2022
K220877 — Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser SystemsLumenis Be, Inc. Jul 15, 2022
K213872 — ComPAS2Morgan Scientific, Inc. Jul 15, 2022
K220127 — NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental HealthNeuronetics, Inc. Jul 15, 2022
K220622 — Hailie Sensor NF0106Adherium (Nz), Ltd. Jul 15, 2022
K220742 — NxtGen Infant Transport IncubatorInternational Biomedical Jul 15, 2022
K221763 — CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation Jul 15, 2022
K221433 — Facet 28G Universal LancetFacet Technologies, LLC Jul 15, 2022
K220970 — Renuvion APR HandpieceApyx Medical Corporation(Formerly Bovie Medical Corporation) Jul 15, 2022
K213997 — Kontact Dental Implant SystemBiotech Dental, Sas Jul 15, 2022
K220619 — Vivid S60N, Vivid S70NGE Medical Systems Ultrasound And Primary Care Diagnostics Jul 15, 2022
K212883 — ers2 - ergoline Rehabilitation SystemErgoline GmbH Jul 15, 2022
K221030 — Model 9100 PFT/DICOVitalograph Ireland, Ltd. Jul 15, 2022
K212778 — Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)Abbott Molecular, Inc. Jul 15, 2022
K213576 — Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical Jul 15, 2022
K220631 — NomadAir PMU810Neurotronics, Inc. Jul 15, 2022
K221876 — Digital Radiography CXDI-Pro, Digital Radiography D1Canon, Inc. Jul 15, 2022
K210665 — Nerve TapeBiocircuit Technologies, Incorporated Jul 15, 2022
K214017 — Examination gloves-Type A(Latex gloves)Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. Jul 14, 2022
K221431 — TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricantChurch & Dwight Co., Inc. Jul 14, 2022
K220862 — E-GPS Navigated InstrumentsPrecision Spine, Inc. Jul 14, 2022
K220040 — CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil SystemsMedos International SARL Jul 14, 2022
K213498 — PELNAC Meshed Bilayer Wound MatrixGunze Limited Jul 14, 2022
K220560 — Dermatac Drape3M Jul 14, 2022
K221203 — AHI SystemFifth Eye, Inc. Jul 14, 2022
K212073 — Alma Diode Tabletop LaserAlma Lasers , Ltd. Jul 14, 2022
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