510(k) Clearances in 2020 — Page 14

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 14 of 59)
510(k) clearancesDetails
K200296 — Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact LensesPegavision Corporation Oct 15, 2020
K201908 — LIAISON Testosterone xtDiaSorin, Inc. Oct 15, 2020
K202364 — Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation Oct 15, 2020
K200207 — xPORT S Lens Fragmentation SystemCarl Zeiss Meditec Cataract Technology, Inc. Oct 15, 2020
K201615 — SIGNA 7.0TGe Medical Systems, LLC Oct 15, 2020
K202680 — OsteoMed ExtremiFix Mini & Small Cannulated Screw SystemOsteomed, LLC Oct 15, 2020
K202041 — Opera EvoQuanta System Spa Oct 15, 2020
K202683 — ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Oct 15, 2020
K200757 — Foley Catheter with Temperature SensorDeroyal Industries, Inc. Oct 15, 2020
K202327 — Invictus™ OsseoScrew® SystemAlphatec Spine, Inc. Oct 15, 2020
K201398 — SINUSPRIME Dilation SystemStryker Ent Oct 15, 2020
K202340 — Droplet Pen Needle 30G & 33GHtl-Strefa S.A Oct 15, 2020
K202665 — Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mmEthicon Endo-Surgery, LLC Oct 15, 2020
K200386 — Z5-BLZ-Systems AG Oct 14, 2020
K201595 — Merit Hydrophilic Guide WireMerit Medical Systems, Inc. Oct 14, 2020
K201562 — SpirotracVitalograph Ireland, Ltd. Oct 14, 2020
K202666 — CONSTRUX Mini PTC Spacer SystemOrthofix, Inc. Oct 14, 2020
K201962 — Skeletal Dynamics Ulnar Shortening Plating SystemSkeletal Dynamics, Inc. Oct 13, 2020
K200114 — Astroglide Organix LiquidBiofilm, Inc. Oct 13, 2020
K202305 — Zavation IBF SystemZavation Medical Products, LLC Oct 13, 2020
K200596 — G21 Cement, VADER® Pedicle SystemIcotec AG Oct 13, 2020
K201828 — Voluson SWIFT, Voluson SWIFT+GE Medical Systems Ultrasound And Primary Care Diagnostics Oct 11, 2020
K202213 — syngo.CT Neuro PerfusionSiemens Medical Solutions USA, Inc. Oct 11, 2020
K202501 — Quantib ProstateQuantib B.V. Oct 11, 2020
K200633 — Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove0 & M Halyard, Inc. Oct 11, 2020
K201528 — Yushan X-Ray Flat Panel Detector with DROCInnocare Optoelectronics Corp. Oct 11, 2020
K201983 — BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)Med-El Elektromedizinische Geraete GmbH Oct 9, 2020
K193631 — Stethee Pro 1, Stethee Pro Software SystemM3Dicine Pty , Ltd. Oct 9, 2020
K202285 — Medline ENfit OTC Feeding SyringeMedline Industries, Inc. Oct 9, 2020
K202740 — Klassic Knee System Tibial Inserts, PS-MaxTotal Joint Orthopedics, Inc. Oct 9, 2020
K200103 — BIOTEQ Drainage Catheter Set (One Step Type)Bioteque Corporation Oct 9, 2020
K201882 — AEON Endoscopic StaplerLexington Medical, Inc. Oct 9, 2020
K200510 — Multi-LinkTM X2 ECG Adapter and LeadwiresVyaire Medical, Inc. Oct 9, 2020
K201038 — Luce Ceramic BracketLuce Castle Co., Ltd. Oct 9, 2020
K192921 — Zeos Aqua Vision Pump and tubeHemodia Sas Oct 9, 2020
K200434 — V20, V20a, AVSM3 SNFMediana Co., Ltd. Oct 9, 2020
K202609 — Instrument Clamps ElectromagneticStryker Corporation Oct 9, 2020
K201377 — SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation Oct 9, 2020
K200767 — SilverStream GelEnzysurge , Ltd. Oct 8, 2020
K200810 — IPS CaseDesignerNobel Biocare AB Oct 8, 2020
K200793 — LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. Oct 8, 2020
K200661 — Steripath Micro Blood Collection SystemMagnolia Medical Technologies, Inc. Oct 8, 2020
K202592 — Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality, L11 LED Light Source with Adavanced Imaging Modality)Stryker Oct 8, 2020
K201777 — 31HN713DLg Electronics.Inc Oct 8, 2020
K201917 — Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics , Ltd. Oct 8, 2020
K202309 — Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion SystemZimmer Biomet Spine, Inc. Oct 8, 2020
K201845 — Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)Guangzhou Longest Science & Technology Co., Ltd. Oct 8, 2020
K201972 — Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation Oct 8, 2020
K201939 — GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz Oct 8, 2020
K201970 — Schoelly Cystoscopes/Hysteroscopes and AccessoriesSchoelly Fiberoptic GmbH Oct 8, 2020
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