510(k) Clearances in 2019 — Page 18

2,918 510(k) clearances total

Browse FDA 510(k) clearances granted in 2019. RegDataLab tracks 2,918 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2019 (page 18 of 59)
510(k) clearancesDetails
K191212 — CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine SystemMedos International SARL Sep 24, 2019
K183391 — Novidia Universal BondNobio , Ltd. Sep 24, 2019
K191006 — EasiSlushBridge TO Life, Ltd. Sep 24, 2019
K192322 — T-Stat 2.0 Microvascular Tissue OximeterSpectros Corporation Sep 23, 2019
K190483 — SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies Sep 23, 2019
K190100 — USTAR II SystemUnited Orthopedic Corporation Sep 23, 2019
K182671 — Medi-Direct TENS PenJkh USA, LLC Sep 21, 2019
K192332 — ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever SheathInari Medical Sep 20, 2019
K181428 — Clyra Wound Irrigation SolutionClyra Medical Technologies, Inc. Sep 20, 2019
K190856 — SeeFactorCT3Epica International, Inc. Sep 20, 2019
K190001 — Supercath 5Togo Medikit Co., Ltd. Sep 20, 2019
K191679 — Omnipod DASH Insulin Management System with interoperable technologyInsulet Corporation Sep 20, 2019
K192402 — syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc. Sep 20, 2019
K192276 — Merge CardioMerge Healthcare Incorporated Sep 20, 2019
K192259 — Philips IntelliSite Pathology SolutionPhilips Electronics Nederland B.V. Sep 20, 2019
K191324 — CivaDermCivatech Oncology, Inc. Sep 20, 2019
K180523 — INTAI Surgery Navigation SystemIntai Technology Corporation Sep 20, 2019
K191927 — Hinged Laminoplasty SystemLife Spine, Inc. Sep 20, 2019
K192301 — BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test StripShenzhen Bioeasy Biotechnology Co., Ltd. Sep 20, 2019
K192296 — Medtronic 6F Taiga Guiding CatheterMedtronic Vascular Sep 20, 2019
K192344 — Sapphire NC Plus Coronary Dilatation CatheterOrbusneich Medical Trading, Inc. Sep 19, 2019
K192326 — HardyDisk AST Lefamulin 20µg (LMU20)Hardy Diagnostics Sep 19, 2019
K182631 — SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)Eurogreen International, Inc. Sep 19, 2019
K192252 — ProPerformance Recovery SystemMenlo Brands, LLC Sep 19, 2019
K192030 — RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. Sep 19, 2019
K191112 — GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC Sep 19, 2019
K190526 — High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics , Ltd. Sep 19, 2019
K182292 — VORTRAN APM-PlusVortran Medical Technology 1, Inc. Sep 18, 2019
K191391 — HEDRON Lumbar SpacersGlobus Medical, Inc. Sep 18, 2019
K191232 — AccuCath Ace Intravascular CatheterC.R. Bard, Inc. Sep 18, 2019
K191663 — Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation Sep 18, 2019
K183103 — EMS Belt (Model MC0485)Dongguan Yingfeng Metal & Plastic Products Co., Ltd. Sep 18, 2019
K190858 — Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal LubricantUnited Consortium Sep 18, 2019
K190563 — 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF CageSolco Biomedical Co., Ltd. Sep 18, 2019
K191552 — GM501 Mineral OilHamilton Thorne, Inc. Sep 18, 2019
K191113 — geko T-2 and geko T-3 Neuromuscular StimulatorsFirstkind Limited Sep 18, 2019
K192254 — InnoSight Diagnostic Ultrasound SystemQisda Corporation Sep 18, 2019
K191357 — Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc. Sep 18, 2019
K183436 — OraCureTbm Corporation Sep 18, 2019
K191187 — Dornier MINNOW Ureteral CatheterDornier Medtech America, Inc. Sep 18, 2019
K191457 — BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)Med-El Elektromedizinische Geraete GmbH Sep 18, 2019
K192065 — Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc. Sep 18, 2019
K192059 — Bio Guard Air/Water & Suction ValvesUnited States Endoscopy Group, Inc. Sep 17, 2019
K191243 — HEDRON Cervical SpacersGlobus Medical, Inc. Sep 17, 2019
K191253 — Reusable NIBP CuffShenzhen Changke Connect Electronics Co., Ltd. Sep 17, 2019
K192037 — Advisor VL Circular Mapping Catheter, Sensor EnabledABBOTT MEDICAL Sep 17, 2019
K191297 — iNSitu Bipolar Hip SystemTheken Companies, LLC Sep 17, 2019
K191842 — Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa Sep 17, 2019
K190308 — Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1)Amd Medicom, Inc. Sep 17, 2019
K181416 — Sapphire Dorsal Comfort FitCrane Dental Laboratory, Inc. Sep 17, 2019
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