510(k) Clearances in 2020 — Page 27

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 27 of 59)
510(k) clearancesDetails
K200464 — LG Pra. L Derma LD Scalp CareLg Electronics.Inc Jul 23, 2020
K193520 — EVA 15 InsufflatorPalliare , Ltd. Jul 23, 2020
K201083 — Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsParcus Medical, LLC Jul 23, 2020
K193450 — Pre-Seed™ Fertility LubricantChurch & Dwight Co., Inc. Jul 23, 2020
K201713 — AVVIGO Guidance SystemBoston Scientific Corporation Jul 23, 2020
K200738 — Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH Jul 23, 2020
K201122 — Canon non-mydriatic retinal camera CR seriesCanon, Inc. Jul 23, 2020
K193528 — Empty EVA BagHaemotronic S.P.A. Jul 22, 2020
K201751 — Pedicle Screw SystemBlack Box Medical, LLC Jul 22, 2020
K201527 — EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)Smith & Nephew, Inc. Jul 22, 2020
K200355 — Duranext AbutmentsElegant Dental Corp. Jul 22, 2020
K201200 — Visera Elite II Video System CenterOlympus Medical Systems Corp. Jul 22, 2020
K201150 — InMode RF Multi-SystemInMode , Ltd. Jul 22, 2020
K201406 — PicowonWontech Co., Ltd. Jul 22, 2020
K200621 — Caption Interpretation Automated Ejection Fraction SoftwareCaption Health Jul 22, 2020
K192998 — Reprocessed BRK Transseptal NeedleInnovative Health, LLC Jul 22, 2020
K193277 — SOMATOM On.site and On.sceneSiemens Medical Solutions USA, Inc. Jul 22, 2020
K201355 — Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KG Jul 22, 2020
K201780 — True Tulip System, True M.I.S. SystemInnovative Surgical Designs, Inc. Jul 22, 2020
K200836 — 8ch Flex SuiteShenzhen RF Tech Co., Ltd. Jul 22, 2020
K200513 — DAC Dynamic Active Compression PlatePioneer Surgical Technology, Inc., Dba Rti Surgical Jul 22, 2020
K201699 — Medline ReNewal Reprocessed Nellcor OxiMax SpO2 SensorSurgical Instrument And Savings Inc (Dba Medline Renewal) Jul 22, 2020
K200869 — Gamma3 SystemStryker Trauma GmbH Jul 22, 2020
K192511 — Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mmVenner Medical (Singapore) Pte, Ltd. Jul 22, 2020
K200654 — Rubicon SA SystemDymedix Diagnostics, Inc. Jul 22, 2020
K192847 — AUTOLIGNDiorco Co., Ltd. Jul 21, 2020
K193607 — BOBBY Balloon Guide CatheterMicroVention, Inc. Jul 21, 2020
K200383 — Wiggins Medical Surgical InstrumentsWiggins Medical Jul 21, 2020
K201690 — Mirage Hydrophilic Guidewire; X-pedion Hydrophilic GuidewireMicro Therapeutics, Inc. D/B/A Ev3 Neurovascular Jul 21, 2020
K193434 — VITA LUMEX ACVita Zahnfabrik GmbH H Rauter & CO Jul 21, 2020
K201689 — Riptide Aspiration SystemMicro Therapeutics, Inc. D/B/A Ev3 Neurovascular Jul 21, 2020
K200387 — Ace Medical Surgical InstrumentsAce Medical Jul 21, 2020
K191875 — Owgels Oxygen ConcentratorGuangzhou Life Light Electronic Technology Co., Ltd. Jul 20, 2020
K192366 — Intravascular Extension Sets and AccessoriesBaxter Healthcare Corporation Jul 20, 2020
K201349 — Smith+Nephew ArthroscopesSmith & Nephew Jul 20, 2020
K193392 — BioSiCar Silicone ImplantMetalware Technology Corp. Jul 20, 2020
K193380 — CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetCodman & Shurtleff, Inc. Jul 20, 2020
K201179 — GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor CableCovidien, LLC Jul 20, 2020
K193603 — Benesta Medical Sterilization TrayCaldera Medical, Inc. Jul 20, 2020
K193022 — Retractable Safety Insulin SyringeJiangsu Caina Medical Co.,Ltd Jul 20, 2020
K200542 — Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera HeadOlympus Medical Systems Corp. Jul 17, 2020
K201798 — myQA iONIba Dosimetry GmbH Jul 17, 2020
K201672 — Signia Stapler (with new software)Covidien Jul 17, 2020
K200818 — 3DMax MID Anatomical MeshC.R. Bard, Inc. Jul 17, 2020
K201098 — Ambu Duodeno SystemAmbu Innovation GmbH Jul 17, 2020
K193204 — Cryocheck Chromogenic Factor VIIIPrecision Biologic Jul 17, 2020
K201465 — SuRgical Planner (SRP) BrainStormSurgical Theater, Inc. Jul 17, 2020
K201198 — S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, AutoclavableSmith & Nephew Jul 17, 2020
K201365 — True 3D ViewerEchopixel, Inc. Jul 17, 2020
K192793 — Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190IOlympus Medical Systems Corp. Jul 17, 2020
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