510(k) Clearances in 2020 — Page 30

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 30 of 59)
510(k) clearancesDetails
K200330 — RC-Prime Root Canal Preparation CreamPac-Dent, Inc. Jul 6, 2020
K200795 — LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool KitMedtronic, Inc. Jul 3, 2020
K200537 — OxxiomTrue Wearables, Inc. Jul 3, 2020
K193259 — Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometerLittle Doctor Electronic (Nantong)Co.,Ltd Jul 2, 2020
K183471 — IC-WHCD100 (Inspire)Good Doctors Co., Ltd. Jul 2, 2020
K192880 — InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd. Jul 2, 2020
K200766 — 3M Attest Steam Chemical Integrator Test Pack3M Company Jul 2, 2020
K200894 — Agape Cooling Personal LubricantCC Wellness, LLC Jul 2, 2020
K201599 — 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+Shenzhen Beacon Display Technology Co., Ltd. Jul 2, 2020
K192872 — ulrichINJECT CT MotionUlrich GmbH & Co. KG Jul 2, 2020
K193252 — Contour ProtegeAIMim Software, Inc. Jul 2, 2020
K192411 — Psoria-Shield AURORAPsoria-Shield Jul 2, 2020
K200674 — AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor ConnectorAtrility Medical, LLC Jul 2, 2020
K193172 — Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc. Jul 2, 2020
K200285 — VenaOneVena Group, LLC Jul 2, 2020
K192385 — ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient CableIvwatch, LLC Jul 2, 2020
K201633 — Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation Jul 2, 2020
K193484 — GC Fuji Triage EPGC America, Inc. Jul 2, 2020
K201487 — Traxcess 7 Mini GuidewireMicroVention, Inc. Jul 2, 2020
K200947 — InMode System with the Morhpeus8 ApplicatorsInMode , Ltd. Jul 2, 2020
K201048 — SherpaPak Pediatric Liver Transport SystemParagonix Technologies Jul 2, 2020
K200561 — StimPlus Patch, StimPlus Patch, StimPlus PatchJkh Health Co., Ltd. Jul 1, 2020
K201477 — syngo.via View&GOSiemens Healthcare GmbH Jul 1, 2020
K200880 — T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2 Greater Trochanter Nail (GTN),T2 Ankle Arthrodesis Nail,T2 Arthrodesis Nail SystemStryker GmbH Jul 1, 2020
K200248 — Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft ObturatorsAllwin Medical Devices, Inc. Jul 1, 2020
K201449 — SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty RingMedtronic, Inc. Jul 1, 2020
K200138 — Versana PremierGe Medical Systems Ultrasound And Jul 1, 2020
K192778 — Kinos Axiom Total Ankle SystemKinos Medical Jun 30, 2020
K201455 — Litho 150, Cyber Ho 150Quanta System Spa Jun 30, 2020
K193632 — LassoStar Circular Mapping CatheterBiosense Webster, Inc. Jun 30, 2020
K191276 — Dental Electrical Motor iRoot ProChangzhou Bomedent Medical Technology Co.,Ltd Jun 30, 2020
K200265 — Surgical DrillsImplant Direct Sybron Manufacturing, LLC Jun 30, 2020
K201464 — Altapore MISBaxter Healthcare Corporation Jun 30, 2020
K200272 — Terragene ChemdyeTerragene S.A. Jun 30, 2020
K200874 — TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal EndInnovasis, Inc. Jun 30, 2020
K200420 — Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, GreenEthicon Endo-Surgery, LLC Jun 29, 2020
K201423 — MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)Beckman Coulter, Inc. Jun 29, 2020
K201503 — Edge Air(1417) Digital Flat Panel X-ray DetectorOsko, Inc. Jun 29, 2020
K193119 — Twin-Pass Dual Access CatheterVascular Solutions, LLC Jun 29, 2020
K201156 — ARTIS pheno (VE2)Siemens Medical Solution USA, Inc. Jun 29, 2020
K200698 — Somnera SystemFresca Medical, Inc. Jun 29, 2020
K192900 — H500 Multi-Sensing Oximetry SystemNonin Medical, Inc. Jun 29, 2020
K200068 — Arthrex DynaNite K-WireArthrex, Inc. Jun 29, 2020
K200354 — Electronic stimulatorShenzhen Dongjilian Electronics Co., Ltd. Jun 29, 2020
K201507 — Cadence Total Ankle SystemIntegra LifeSciences Corporation Jun 29, 2020
K200888 — OMNIBotics Knee SystemCorin, Ltd. Jun 27, 2020
K201119 — ChartCheckRadformation, Inc. Jun 26, 2020
K193525 — Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin MHORIBA ABX SAS Jun 26, 2020
K182081 — JDentalCare Implant System JDIconJdentalcare Srl Jun 26, 2020
K200095 — Streamline Navigated InstrumentsPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. Jun 26, 2020
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