510(k) Clearances in 2020 — Page 36

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 36 of 59)
510(k) clearancesDetails
K181691 — High-speed air turbine handpiece / Low-speed air turbine handpieceFoshan Wenjian Medical Instrument Co., Ltd. May 26, 2020
K200032 — ReWalk P6.0Re Walk Robotics , Ltd. May 26, 2020
K201118 — Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser LevelMedtronic, Inc. May 26, 2020
K192392 — DiaPlusDiaDent Group International May 26, 2020
K200410 — Reconnaissance PV .018 OTW Digital IVUS CatheterPhilips Image Guided Therapy Corporation May 22, 2020
DEN190037 — NaviCam Capsule Endoscope System with NaviCam Stomach CapsuleAnx Robotica, Inc. May 22, 2020
K200419 — Kalera Vacuum Aspiration Catheter (K-VAC)Kalera Medical, Inc. May 22, 2020
K193423 — VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG May 22, 2020
K200936 — Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc. May 22, 2020
K192488 — CO2 Sidestream ModuleBeijing Kingst Commercial & Trade Co., Ltd. May 22, 2020
K200246 — JPS JuniOrtho Plating SystemOrthofix Srl May 22, 2020
K191847 — Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use Non-stick Bipolar ForcepsAdeor Medical AG May 22, 2020
K192560 — Surgical GownShandong Kangli Medical Equipment Technology Co., Ltd. May 22, 2020
K200126 — VERIFY Assert Self-Contained Biological IndicatorSTERIS Corporation May 22, 2020
K200457 — Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One WarmingCC Wellness, LLC May 22, 2020
K190559 — SmartPort+ Implantable Ports, SmartPort Plastic Implantable PortsAngioDynamics, Inc. May 22, 2020
K200468 — V30 system, V20 system, V10 system, V-FC HandpieceViora , Ltd. May 21, 2020
K200662 — X-Guide® Surgical Navigation SystemX-Nav Technologies, LLC May 21, 2020
K200483 — SpyGlass Discover Digital Catheter, SpyGlass Discover Digital ControllerBoston Scientific Corporation May 21, 2020
K200956 — NuVasive Thoracolumbar PlatesNu Vasive, Incorporated May 21, 2020
K200252 — Getinge Assured MI Steam Migrating IntegratorSteritec Products Mfg Co, Inc. May 21, 2020
K201106 — IntraMarX 3D Radiopaque MarkerAnx Robotica Corp May 21, 2020
K200737 — SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part Of Stryker) May 21, 2020
K200751 — Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd. May 21, 2020
K200274 — CariCloudCaristo Diagnostics May 21, 2020
K192879 — Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound SystemEdan Instruments, Inc. May 21, 2020
K200969 — NEXXT MATRIXX SystemNexxt Spine, LLC May 21, 2020
K192342 — Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories)Hangzhou AGS MedTech Co., Ltd. May 21, 2020
K192265 — gi-4000 Electrosurgical GeneratorUnited States Endoscopy Group, Inc. May 21, 2020
K200995 — Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc. May 21, 2020
K192446 — CO2 Mainstream ModuleBeijing Kingst Commercial & Trade Co., Ltd. May 21, 2020
K193391 — BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. May 21, 2020
K201086 — Advincula Delineator Uterine ManipulatorCooperSurgical, Inc. May 21, 2020
K200400 — Systane iLux2Tear Film Innovations, Inc. May 21, 2020
K191512 — LotusCatheter (Lotus No Balloon Catheter)Hakki Medical Technologies, Inc. May 21, 2020
K201068 — Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive SurfaceMedtronic, Inc. May 21, 2020
K200352 — Axis Spine Technologies ALIFAxis Spine Technologies, Ltd. May 20, 2020
K201078 — NuVasive® ACP SystemNu Vasive, Incorporated May 20, 2020
K192399 — Infinity Angioplasty Balloon CatheterInfinity Angioplasty Balloon Company, LLC May 20, 2020
K192727 — K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)Kamiya Biomedical Company May 20, 2020
K200860 — HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)M.I.Tech Co., Ltd. May 20, 2020
K191362 — LifeFlow Blood System410 Medical, Inc. May 20, 2020
K200749 — CUBEScan BioCon-900SMcube Technology Co., Ltd. May 19, 2020
K200303 — Reform Pedicle Screw SystemPrecision Spine May 19, 2020
K192016 — SMOOV O10Alber GmbH May 19, 2020
K200864 — 5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+Shenzhen Beacon Display Technology Co., Ltd. May 19, 2020
K201124 — TOPAZ Mobile DR SystemDRGEM Corporation May 19, 2020
K201062 — syngo Ultrasound Apps Suite (sUSAS)Siemens Medical Solutions USA, Inc. May 18, 2020
K200431 — 3D GraftRasp SystemSurgentec May 18, 2020
K193404 — UF(II) Bar holder abutmentDio Corporation May 18, 2020
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