510(k) Clearances in 2018 — Page 12

3,062 510(k) clearances total

Browse FDA 510(k) clearances granted in 2018. RegDataLab tracks 3,062 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2018 (page 12 of 62)
510(k) clearancesDetails
K171199 — AVIEWCoreline Soft Co., Ltd. Oct 31, 2018
DEN180028 — 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports23AndMe, Inc. Oct 31, 2018
K181553 — Immunalysis Ethyl Alcohol Enzyme AssayImmunalysis Corporation Oct 31, 2018
K182588 — Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/DividerSurgical Instrument Service And Savings Inc.(Dba Medline Ren Oct 31, 2018
K180735 — Endomat SelectKarl Storz SE & CO. KG Oct 31, 2018
K180718 — ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIESTomy, Inc. Oct 30, 2018
K182540 — DiLumen Endolumenal Interventional PlatformLumendi, LLC Oct 30, 2018
K182381 — Wilson-Cook Mini BasketWilson-Cook Medical, Inc. Oct 30, 2018
K182062 — Sysmex UD-10, Fully Automated Urine Particle Digital Imaging DeviceSysmex America, Inc. Oct 30, 2018
K182066 — O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer SetCook Incorporated Oct 30, 2018
K182063 — VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated SystemOrtho-Clinical Diagnostics, Inc. Oct 30, 2018
K181550 — Cios SpinSiemens Medical Solutions USA, Inc. Oct 30, 2018
K182072 — VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU SlidesOrtho-Clinical Diagnostics, Inc. Oct 30, 2018
K182466 — AOS Calcaneal Plating SystemAdvanced Orthopaedic Solutions Oct 30, 2018
K182392 — Frozen CB.M. Tech. Worldwide Co., Ltd. Oct 30, 2018
K181488 — LIGACLIP 12mm L Endoscopic Rotating Multiple Clip ApplierEthicon Endo-Surgery, LLC Oct 30, 2018
K180354 — UroGen Ureteral CatheterUrogen Pharma, Ltd. Oct 30, 2018
K181239 — Infrared Forehead Thermometer, Infrared Ear/Forehead ThermometerJoytech Healthcare Co. , Ltd. Oct 29, 2018
K180559 — HSV 1 & 2 ELITe MGB Kit; ELITe InGeniusElitechgroup Oct 29, 2018
K182215 — ClearLink Controlled Phototherapy EquipmentDaavlin Distributing Company Oct 29, 2018
K182914 — MC3 Vascular Access Kit 21030Mc3 Incorporated Oct 29, 2018
K180020 — HemoScreen Hematology AnalyzerPixcell Medical Technologies, Ltd. Oct 29, 2018
K181458 — Reprocessed Advisor FL Sensor Enabled Circular Mapping CatheterInnovative Health, LLC Oct 27, 2018
K180980 — ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC Oct 27, 2018
K180487 — Peak.meBreathe Me, Ltd. Oct 26, 2018
K170732 — Biomate Dental Implant SystemBiomate Medical Devices Technology Co., Ltd. Oct 26, 2018
K181031 — TSI Transseptal IntroducerPressure Products Medical Device Manufacturing, LLC Oct 26, 2018
K173965 — Implant Planning SoftwareInteware Co., Ltd. Oct 26, 2018
K180286 — Polyethylene CatheterCook Incorporated Oct 26, 2018
K180285 — PENTAX Medical Video Colonoscope EC34-i10T SeriesPentax Medical Of America, Inc. Oct 26, 2018
K181898 — Two-Step Implant SystemTrilliant Surgical Oct 26, 2018
K182177 — AccipiolxMaxq-Al , Ltd. Oct 26, 2018
K182767 — V2 OTC Pain Relief TENSEveryway Medical Instruments Co.,Ltd Oct 26, 2018
K181739 — Invisalign System with Mandibular Advancement FeatureAlign Technology, Inc. Oct 26, 2018
K182041 — Dexcom G6 Glucose Program Continuous Glucose Monitoring SystemDexcom, Inc. Oct 26, 2018
K182501 — Hair Laser HeadbandPulsaderm, LLC Oct 26, 2018
K182299 — MAGNETOM AeraSiemens Medical Solutions USA, Inc. Oct 26, 2018
K180300 — Margolin HSG Cannula, Goldstein Sonohysterography CatheterCook Incorporated Oct 26, 2018
K182753 — A6 OTC Pain Relief TENSEveryway Medical Instruments Co.,Ltd Oct 26, 2018
K180291 — Cook Silicone Balloon HSG CatheterCook Incorporated Oct 26, 2018
K181116 — CONVIVOCarl Zeiss Meditec, AG Oct 25, 2018
K181186 — Solitare Platinum Revascularization DeviceMicro Therapeutics, Inc. D/B/A Ev3 Neurovascular Oct 25, 2018
K181468 — Hybrid3DHermes Medical Solutions AB Oct 25, 2018
K173944 — Endocular Viewing Lenses and Silicone RingPhakos Oct 25, 2018
K182706 — External upper limb tremor stimulatorCala Health, Inc. Oct 25, 2018
K170723 — Swaive Thermometer SWT1AE-Care Technology Co., Ltd. Oct 25, 2018
K181947 — Persona Revision Knee SystemZimmer, Inc. Oct 25, 2018
K181354 — 074 Zenith Flex SystemInneuroco, Inc. Oct 25, 2018
K182171 — SMV Scientific K-Wire and PinsSummit Medventures Oct 25, 2018
K181936 — DyeVert PLUS EZ Contrast Reduction SystemOsprey Medical, Inc. Oct 25, 2018
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