510(k) Clearances in 2022 — Page 34

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 34 of 65)
510(k) clearancesDetails
K213913 — leva Pelvic Health SystemRenovia, Inc. Jun 30, 2022
K220651 — Wrist Type Blood Pressure MonitorShenzhen Jamr Medical Technology Co., Ltd. Jun 30, 2022
K220378 — Sparta 3-Ply Surgical Disposable Face MaskSparta East, LLC Jun 30, 2022
K213582 — Epicardial Access SystemBaylis Medical Company, Inc. Jun 30, 2022
K212418 — hCG One Step Pregnancy TestHealstone Biotech, Inc. Jun 30, 2022
K221569 — Intense Pulsed Light (IPL) System, model: T013C, T015C, T015KShenzhen Fansizhe Science And Technology Co., Ltd. Jun 30, 2022
K221750 — CPS AIM Universal II Slittable Inner CatheterABBOTT MEDICAL Jun 30, 2022
K221050 — ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate SystemAegis Spine, Inc. Jun 30, 2022
K212785 — Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutmentsBlue Sky Bio, LLC Jun 30, 2022
K221571 — InMode Multi-systemInMode , Ltd. Jun 30, 2022
K213949 — VASSALLO GT 018 FloppyFilmecc Co., Ltd. Jun 30, 2022
K203597 — Cholesterol2Abbott Ireland Diagnostics Division Jun 30, 2022
K220634 — NC TREK NEO Coronary Dilatation CatheterAbbott Vascular Jun 30, 2022
K221286 — CLAROXVsi Co., Ltd. Jun 29, 2022
K220960 — BruxZir Opaque Coloring LiquidPrismatik Dentalcraft, Inc. Jun 29, 2022
K220934 — RADIFOCUS Torque DeviceTerumo Medical Products (Hangzhou) Co., Ltd. Jun 29, 2022
K220409 — ARTIS pheno (VE21) SystemSiemens Medical Solutions USA, Inc. Jun 29, 2022
K213231 — Kerecis SiliconeKerecis Limited Jun 29, 2022
K220017 — Coloring LiquidDongguan Xiangtong Co., Ltd. Jun 29, 2022
K220289 — FridaMom Anti-Nausea BandsFridababy, LLC Jun 29, 2022
K221714 — Flat Panel DetectorIray Technology Taicang , Ltd. Jun 29, 2022
K220432 — ARTIS icono (VE21) SystemSiemens Medical Solutions USA, Inc. Jun 29, 2022
K220937 — Arthrex Mini Fragment SystemArthrex, Inc. Jun 29, 2022
K211016 — Powered Breast Pump (Models 7V and 7X)Haenim Co., Ltd. Jun 29, 2022
K221312 — Diode Laser Hair Removal DeviceGuangzhou Chuang Zao Mei Technology Co., Ltd. Jun 29, 2022
K220834 — Powder Free Nitrile Examination GloveDaxwell, LLC Jun 29, 2022
K220975 — V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. Jun 29, 2022
K221611 — 780 nm L11 LED Light Source with AIMStryker Jun 29, 2022
K213794 — Eko Murmur Analysis Software (EMAS)Eko Devices, Inc. Jun 29, 2022
K220410 — Ebony HP PTA OTW 0.035 CatheterNatec Medical , Ltd. Jun 29, 2022
K220544 — DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)Ra Medical Systems,Inc Jun 29, 2022
K220449 — DePuy CONDUIT LLIF SQUID InserterEnztec Limited Jun 28, 2022
K220670 — MagnumMagnum Health And Safety Pvt, Ltd. Jun 28, 2022
K211076 — Patient Specific Marking GuidesAdditive Orthopaedics, LLC Jun 28, 2022
K211718 — Venus Cervical Plate SystemArtfx Medical, LLC Jun 28, 2022
K221273 — Medical Face Mask (M001)Xingyu Medical Tech Co., Ltd. Jun 28, 2022
K211705 — 3M Attest Rapid Readout Biological Indicator, 12953M Company Jun 28, 2022
K213577 — VenAir, Sequential Compression SystemApex Medical Corp. Jun 28, 2022
K221256 — Mg OSTEOINJECTBone Solutions, Inc. Jun 28, 2022
K220447 — Med-link Disposable ECG Cable and LeadwiresShenzhen Med-Link Electronics Tech Co., Ltd. Jun 28, 2022
K221272 — Medical Face MaskShandong Xingyu Gloves Co., Ltd. Jun 28, 2022
K221195 — OsteoProbeActive Life Scientific, Inc. Jun 28, 2022
K213478 — BD Pen NeedleBecton, Dickinson And Company Jun 28, 2022
K213726 — PL-1 Skin Treatment SystemAVAVA, Inc. Jun 28, 2022
K220309 — Wearable Breast Pump (Model S10)Shenzhen Lutejiacheng Technology Co., Ltd. Jun 27, 2022
K213786 — CiRX Single use electrosurgical pencil with non-coated and coated electrodeNingbo Shun YE Medical Company, Ltd. Jun 27, 2022
K221233 — DT-703Ecotron Co., Ltd. Jun 27, 2022
K220851 — VenueGE Medical Systems Jun 27, 2022
K220790 — Disposable Polypectomy Snare, Disposable Polypectomy Hybrid SnareYangzhou Fartley Medical Instrument Technology Co., Ltd. Jun 27, 2022
K213818 — VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon CannulaCovidien Jun 27, 2022
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