510(k) Clearances in 2020 — Page 57

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 57 of 59)
510(k) clearancesDetails
K193509 — AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QXAcutus Medical, Inc. Jan 17, 2020
K192563 — Altera gas Sampling LinesMeditera Tibbi Malzeme San VE Tic AS Jan 17, 2020
K192583 — PicoLazer Laser SystemRohrer Aesthetics, LLC Jan 17, 2020
K190871 — Bio-TackS Orthodontic Mini ImplantBiocetec Co., Ltd. Jan 17, 2020
K193182 — Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp. Jan 17, 2020
K193570 — Dental Pain EraserSynapse Dental Jan 17, 2020
K193007 — LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording ModuleLina Medical Aps Jan 17, 2020
K192547 — MAGLUMI 2000 HCG/ß-HCGShenzhen New Industries Biomedical Engineering Co., Ltd. Jan 17, 2020
K193507 — Merit ONE Snare SystemMerit Medical Systems, Inc. Jan 17, 2020
K192926 — RxSight Insertion DeviceRxsight, Inc. Jan 17, 2020
K181089 — SureLead Cable SystemAuthentic Medical Jan 17, 2020
K193590 — CareSens S Fit BT Blood Glucose Monitoring SystemI-Sens, Inc. Jan 17, 2020
K193547 — CustomizedBone ServiceFin-Ceramica Faenza S.P.A. Jan 17, 2020
K192495 — Black Diamond Navigation InstrumentsOsseus Fusion Systems Jan 17, 2020
K192182 — C015Micronica Srl Jan 17, 2020
K192211 — SoundBite Console, SoundBite Active Wire 18Soundbite Medical Solution, Inc. Jan 17, 2020
K192302 — Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen CatheterCovidien, LLC Jan 17, 2020
K193543 — CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating SystemIn2Bones USA, LLC Jan 17, 2020
K192635 — Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)Wrp Asia Pacific Sdn. Bhd. Jan 17, 2020
K192606 — SAC2 - Electrode CreamSpes Medica Srl Jan 17, 2020
K192956 — Auto PositioningGe Hangwei Medical Systems Co., Ltd. Jan 16, 2020
K192750 — AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC Jan 16, 2020
K191802 — Electric Breast PumpNingbo Huiyoo Baby Products Co., Ltd. Jan 16, 2020
K193611 — Viveve 2.0 SystemViveve Medical, Inc. Jan 16, 2020
K193488 — GlideScope BFlex 3.8 Single-Use BronchoscopeVerathon Medical (Canada) Ulc Jan 16, 2020
K191095 — Maxxi Snore SensorNeurovirtual USA, Inc. Jan 16, 2020
K192869 — SherpaPak Lung Preservation System , SherpaPak Liver Transport SystemPragonix Technologies Jan 16, 2020
K193500 — Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd. Jan 16, 2020
K192357 — INNOVOAtlantic Therapeutics, Ltd. Jan 16, 2020
K192942 — ALLthread Titanium Suture AnchorBiomet, Inc. Jan 16, 2020
K191831 — MobiliT CupCorin U.S.A. Limited Jan 16, 2020
K191538 — Resectr Tissue Resection DeviceBoston Scientific Corporation Jan 16, 2020
K191266 — VitalScan ANSMedeia, Inc. Jan 15, 2020
K193225 — KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital RadiographyKonica Minolta Healthcare Americas, Inc. Jan 15, 2020
K190028 — UNO 30Genadyne Biotechnologies Jan 15, 2020
K183284 — INTRAcel RF Microneedle SystemJeisys Medical, Inc. Jan 15, 2020
K192251 — Livento Press, Soprano 10, SopranoCendres+Metaux SA Jan 15, 2020
K191275 — All’InCath 035M PTA Balloon Dilatation CatheterNexstep Medical Jan 15, 2020
K193493 — ADVIA Centaur Total IgE (tIgE)Siemens Healthcare Diagnostics, Inc. Jan 15, 2020
K192004 — Eko Analysis SoftwareEko Devices, Inc. Jan 15, 2020
K181005 — ClenchGuardBoyd Research, Inc. Jan 15, 2020
K193503 — Arthrex SwiveLock Suture AnchorArthrex, Inc. Jan 15, 2020
K192454 — Wattson Temporary Pacing GuidewireVascular Solutions Jan 15, 2020
K190981 — NEX-D2 Posterior Fixation SystemNext Orthosurgical Jan 15, 2020
K191125 — ADAS 3DGalgo Medical S.L Jan 15, 2020
K192429 — Dental Pain EraserSynapse Dental Jan 14, 2020
K192800 — Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) Jan 14, 2020
K193478 — XTRAC Momentum Excimer Laser SystemStrata Skin Sciences, Inc. Jan 14, 2020
K193188 — MiiS Horus Eye Anterior CameraMedimaging Integrated Solution, Inc (Miis) Jan 14, 2020
K192920 — Oragene®•DxDNA Genotek, Inc. Jan 14, 2020
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