510(k) Clearances in 2022 — Page 56

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 56 of 65)
510(k) clearancesDetails
K213189 — Wrist-type Fully Automatic Digital Blood Pressure MonitorJoytech Healthcare Co. , Ltd. Mar 1, 2022
K210073 — Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia DuoFresenius Kabi AG Mar 1, 2022
K202046 — LOTA SLA Dental Implant System and LOTA HA Dental Implant SystemKj Meditech Co., Ltd. Mar 1, 2022
K212057 — Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOSArtventive Medical Group, Inc. Mar 1, 2022
K210848 — Sure-Fine Insulin SyringesShina Med Corporation Mar 1, 2022
K211868 — MYAHVisia Imaging S.R.L. Mar 1, 2022
K213590 — Blue Topaz Sacroiliac Screw SystemOsseus Fusion Systems, LLC Mar 1, 2022
K211776 — Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)Microlife Intellectual Property GmbH Mar 1, 2022
K210075 — Vigilant Software Suite – Vigilant Master MedFresenius Kabi AG Mar 1, 2022
K212596 — Sterile Latex Surgical Gloves Powder FreeAmazing Rubber Products Pvt, Ltd. Mar 1, 2022
K210811 — Dynamyx Digital Pathology SoftwareInspirata, Inc. Mar 1, 2022
K213400 — Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play StrawberryRb Health (Us) Mar 1, 2022
K212187 — Restoration® Modular Hip SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics Mar 1, 2022
K220109 — DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc. Mar 1, 2022
K211802 — GoBack Crossing CatheterUpstream Peripheral Technologies, Ltd. Mar 1, 2022
K211484 — Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety NeedlesShinva Ande Healthcare Apparatus Co., Ltd. Mar 1, 2022
K212945 — Sterile Disposable Temperature ProbeShenzhen Envisen Industry Co., Ltd. Mar 1, 2022
K210151 — Digimamo DVmi Tecnologias Ltda Mar 1, 2022
K212833 — Disposable Nitrile Examination GlovesChifeng Huawei Medical Science&Technology Co., Ltd. Feb 28, 2022
K211661 — ENFit enteral syringes (NUTRIFIT)Pentaferte Italia S.R.L. Feb 28, 2022
K213635 — Vathin Video Bronchoscope SystemHunan Vathin Medical Instrument Co., Ltd. Feb 28, 2022
K213750 — VyLink™ Spinal Screw SystemVy Spine, LLC Feb 28, 2022
K193406 — CardioChek Plus Test System; CardioChek Plus Home Test SystemPolymer Technology Systems, Inc. D/B/A Pts Diagnostics Feb 26, 2022
K203113 — Masimo SedLine Sedation Monitor and AccessoriesMasimo Corporation Feb 25, 2022
K213693 — MAGNETOM Vida with syngo MR XA50ASiemens Medical Solutions USA, Inc. Feb 25, 2022
K213241 — VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS FluconazolebioMerieux, Inc. Feb 25, 2022
K220217 — Normatec 3NormaTec Industries, LP Feb 25, 2022
K212300 — Pulse OximeterShenzhen Mericonn Technology Co., Ltd. Feb 25, 2022
K220238 — Cohitech Cottonlock Tampons with Reusable ApplicatorCotton High Tech S.L. Feb 25, 2022
K213043 — Levator Elite (Model LE9011)Shenzhen Dongdixin Technology Co., Ltd. Feb 25, 2022
K212800 — PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A. Feb 25, 2022
K213084 — Ear Thermometer, Model ET005, ET008, ET009Guangzhou Berrcom Medical Device Co., Ltd. Feb 25, 2022
K214066 — FEops HEARTguideFeops NV Feb 25, 2022
K203541 — Okamoto 002 Lubricated Polyurethane Male CondomOkamoto USA, Inc. Feb 25, 2022
K211855 — Ion Facet Screw SystemSurGenTec, LLC Feb 25, 2022
K211711 — OmniTom EliteNeurologica Corporation, A Subsidiary Of Samsung Electronics Feb 25, 2022
K211722 — Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation Feb 25, 2022
K214097 — Explorer Air IISurgvision GmbH Feb 25, 2022
K203150 — Cool-tip RF Ablation System E SeriesCovidien, LLC Feb 25, 2022
K202845 — Bodygard SFS Surgical Gown Level 3Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi Feb 24, 2022
K211320 — CAPRI Corpectomy Cage SystemK2M, Inc. Feb 24, 2022
K220384 — ArtiSential Laparoscopic Instruments-ElectrodesLivsmed, Inc. Feb 24, 2022
K214100 — LuminicePremier North America, Inc. Feb 24, 2022
K220028 — NightOwlEctosense NV Feb 24, 2022
K210135 — PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing3M Healthcare Business Group Feb 24, 2022
K212949 — Sterile Syringe with Safety Needle for Single Use, Sterile Syringe with Needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use, Sterile Needle for Single UseHenan Nursecare Biotechnology Co., Ltd. Feb 24, 2022
K211645 — EpioneQuantum Surgical Sas Feb 24, 2022
K214094 — ROKI Surgical MaskRoki Co., Ltd. Feb 24, 2022
K213941 — Annalise Enterprise CXR Triage PneumothoraxAnnalise-Ai Feb 24, 2022
K211510 — uLab Systems Dental Aligner KitUlab Systems, Inc. Feb 24, 2022
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