510(k) Clearances in 2020 — Page 42

2,923 510(k) clearances total

Browse FDA 510(k) clearances granted in 2020. RegDataLab tracks 2,923 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2020 (page 42 of 59)
510(k) clearancesDetails
K193326 — ARTIS IconoSiemens Medical Solutions USA, Inc. Apr 16, 2020
K193561 — Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel PouchWeihai Xingtai Packaging Products Co., Ltd. Apr 15, 2020
K193373 — Comprehensive® Reverse ShoulderBiomet, Inc. Apr 15, 2020
K193181 — Serranator PTA Serration Balloon CatheterCagent Vascular, LLC Apr 15, 2020
K200613 — Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation Apr 15, 2020
K200092 — 3MTM AttestTM Mini Auto-reader 490M3M Apr 15, 2020
K200625 — I-View Gold and Imagen Gold Dental SensorsTrident S.R.L Apr 15, 2020
K200181 — Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateComfort Rubber Gloves Industries Sdn. Bhd. Apr 15, 2020
K191930 — 7 mm Extended Length EndoscopeMaquet Cardiovascular, LLC Apr 15, 2020
K200500 — Molekule Air Pro RXMolekule, Inc. Apr 15, 2020
K193534 — Monarch PlatformAuris Health, Inc. Apr 15, 2020
K192588 — G-EYE SystemSmart Medical Systems , Ltd. Apr 15, 2020
K200707 — ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Apr 15, 2020
K200887 — AS-10Canon, Inc. Apr 15, 2020
K200388 — Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer ConnectorGa Health Company Limited Apr 14, 2020
K192781 — UroLift System Procedure Kit Sterilization TrayNeotract, Inc. Apr 14, 2020
K191654 — SILICONE Personal LubricantBath Concept Cosmetics (Dongguan) Co., Ltd. Apr 14, 2020
K193349 — Vapocoolshot MistVapocoolshot, Inc. Apr 14, 2020
K200703 — JiveXVisus Health IT GmbH Apr 14, 2020
K193369 — Xelis Dental 2.0Infinitt Healthcare Co., Ltd. Apr 14, 2020
K191803 — Orthopedic Fixation PinTinavi (Anhui) Medical Technologies Co., Ltd. Apr 14, 2020
K191353 — COMET Lumbar Interbody Fusion CageBaui Biotech Co., Ltd. Apr 14, 2020
K193363 — Dermapose RefreshPuregraft, LLC Apr 14, 2020
K200403 — Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation Apr 14, 2020
K182400 — Solax Powered Wheelchair (Models: S7101, S7103)Dongguan Prestige Sporting Goods Co., Ltd. Apr 14, 2020
K192982 — KY Grosz UltraGelRb Health (Us), LLC Apr 14, 2020
K192850 — Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22Qura S.R.L Apr 13, 2020
K200099 — s-Clean SQ-SL Implant System MiniDentis Co., Ltd. Apr 13, 2020
K200300 — VivAer StylusAerin Medical, Inc. Apr 13, 2020
K192167 — CuraRad-ICHCuracloud Corp. Apr 13, 2020
K200215 — ADVIA Centaur CEA AssaySiemens Healthcare Disgnostics, Inc. Apr 13, 2020
K193464 — ND:YAG LaserBeijing Superlaser Technology Co., Ltd. Apr 13, 2020
K192838 — Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium PressureSpectrum Medical , Ltd. Apr 13, 2020
K200726 — AcuityPDRRadmedix, LLC Apr 13, 2020
K200665 — VERASENSE for Stryker TriathlonOrthosensor, Inc. Apr 12, 2020
K193275 — Nerve and Muscle StimulatorShenzhen Xft Medical Limited Apr 11, 2020
K193215 — Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V. Apr 10, 2020
K193282 — SIGNA PremierGe Healthcare (Ge Medical Systems, LLC) Apr 10, 2020
K200644 — ACUSON Freestyle Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Apr 10, 2020
K200642 — OrthAlign Plus SystemOrthalign, Inc. Apr 10, 2020
K200072 — KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acidKimberly-Clark Corporation Apr 10, 2020
K200112 — Zimmer Hip Joint ReplacementZimmer GmbH Apr 10, 2020
K193573 — Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI MicroMolnlycke Health Care Us, LLC Apr 10, 2020
K200078 — VARO Plan3D Industrial Imaging Co., Ltd. Apr 10, 2020
K200044 — SkinStylus SteriLock MicroSystemEsthetic Education, LLC Apr 10, 2020
K190353 — Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTracResidential Home Sleep Services Apr 10, 2020
K200668 — DR-ID 1200SDK SystemFujifilm Corporation Apr 10, 2020
K192679 — Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single UseGemtier Medical (Shanghai), Inc. Apr 10, 2020
K200713 — EchoNavigatorPhilips Medical Systems Nederland B.V. Apr 9, 2020
K200326 — Powder Free Nitrile Examination Glove (Aqua Green)Riverstone Resources Sdn Bhd Apr 9, 2020
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