510(k) Clearances in 2020 — Page 10

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 10 of 59)
510(k) clearancesDetails
K200886 — StimSiteAllotrope Medical, Inc. Nov 10, 2020
K201976 — SnapshotNIRKent Imaging Nov 10, 2020
K200098 — VagiVital AktivgelPeptonic Medical AB Nov 10, 2020
K193214 — WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off ScrewsBiomet, Inc. Nov 10, 2020
K200428 — Multi-Drive Interference Screw SystemNvision Biomedical Technologies, Inc. Nov 10, 2020
K193432 — Vantage PSI System3D Systems Nov 9, 2020
K203128 — EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUSOlympus Medical Systems Corp. Nov 9, 2020
K193190 — BD PureHub Disinfecting CapBecton, Dickinson And Company Nov 9, 2020
K201269 — Accula Strep A TestMesa Biotech, Inc. Nov 9, 2020
K201431 — OGYILI TENS/NMES StimulatorGongguan Tutamen Metalwork Co., Ltd. Nov 9, 2020
K200005 — Concinnity AlignersDrake Precision Dental Laboratory, Inc. Nov 9, 2020
K201990 — DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. Nov 9, 2020
K203110 — iFuse Implant System - iFuse NavigationSI-BONE, Inc. Nov 9, 2020
K202274 — Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kitsBoston Scientific Neuromodulation Nov 9, 2020
K192621 — Medical RFTriworks Group Srl Nov 6, 2020
K202664 — Clio Prime and Clio PedoSota Precision Optics, Inc. Dba Sota Imaging Nov 6, 2020
K202589 — APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire SystemMedartis AG Nov 6, 2020
K201669 — SimpleSENSENanowear, Inc. Nov 6, 2020
K200077 — BioMin Restore PlusDr. Collins, Inc. Nov 6, 2020
K201091 — V-Print splintVoco GmbH Nov 6, 2020
K200811 — cobas u 701 microscopy analyzerRoche Diagnostics Nov 6, 2020
K203061 — Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-600 and HC-1500),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-800 and HC-1000),Evolution Automated Loading and Unloading System (ALUS)STERIS Corporation Nov 6, 2020
K202587 — ATEC Lateral Interbody SystemAlphatec Spine, Inc. Nov 6, 2020
K200750 — Neuro.Al AlgorithmTerarecon,Inc. Nov 6, 2020
K200672 — Durex Penck Standard, Durex Penck XLRb Health (Us), LLC Nov 6, 2020
K202583 — BioShield biopsy valve EUS - LinearSTERIS Corporation Nov 6, 2020
K203076 — Mecta-C Stand Alone ExtensionMedacta International S.A. Nov 6, 2020
DEN200033 — NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging CableNightware, Inc. Nov 6, 2020
K202427 — Aqueduct 100 Plus Cervical Dilation Balloon CatheterGtimd, LLC Nov 6, 2020
K193562 — AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc. Nov 6, 2020
K202244 — SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies Ulc. (Now A Part Of Stryker) Nov 5, 2020
K201741 — Gabriel 3 Way EnFit ValveSyncro Medical Innovations, Inc. Nov 5, 2020
K201827 — GR-17 Resin SystemPro3Dure Medical GmbH Nov 5, 2020
K201902 — MammaPrintAgendia, Inc. Nov 5, 2020
K201877 — OtoSet- Ear Cleaning SystemSafkan, Inc. Nov 5, 2020
K203025 — LOBO Vascular Occlusion System (model LOBO-5)Okami Medical Nov 5, 2020
K202476 — Salvo® Spine SystemSpine Wave, Inc. Nov 5, 2020
K200017 — Eclipse DermaFlex CannulaEclipse Medcorp, LLC Nov 5, 2020
K203154 — KASILOF Cervical Plate SystemKahtnu Surgical, Inc. Nov 5, 2020
K202581 — Arthrex TightRope IIArthrex, Inc. Nov 4, 2020
K182084 — Sweden & Martina Surgical Tray (Model ZSHORTY-INT)Sweden & Martina S.P.A. Nov 4, 2020
K202624 — Z-Span Plate SystemZavation Medical Products, LLC Nov 4, 2020
K200350 — MyHip Planner & VerifierMedacta International S.A. Nov 4, 2020
K202422 — Arietta 65Hitachi Healthcare Americas Nov 4, 2020
K201941 — Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc. Nov 4, 2020
K193499 — DigiGuide SystemProtomed, Inc. Nov 4, 2020
K201840 — Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)Rebound Therapeutics Nov 4, 2020
K202198 — FlareHawk Interbody Fusion SystemIntegrity Implants, Inc. Nov 3, 2020
K191940 — Palm NRG cellulite and muscle toning body deviceHeat IN A Click Nov 3, 2020
K200071 — Blue Beacon Submucosal Injectable SolutionMicro-Tech (Nanjing) Co., Ltd. Nov 3, 2020
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