510(k) Clearances in 2019 — Page 6

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 6 of 59)
510(k) clearancesDetails
K191522 — Straumann Modular CassetteInstitut Straumann AG Dec 3, 2019
K183371 — Deka Tiac 1El..En. Electroic Engineering Spa Dec 3, 2019
K193160 — Glidesheath Slender Tibial Pedal KitTerumo Medical Coporation Dec 3, 2019
K192528 — CO2 Laser Therapy SystemShangdong Huamei Technology Co., Ltd. Dec 3, 2019
K193009 — Promisemed Heel Blood LancetPromisemed Hangzhou Meditech Co., Ltd. Dec 3, 2019
K190009 — Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)Hong Qiangxing (Shenzhen) Electronics Limited Dec 2, 2019
K183622 — NasalCEASE and BleedCEASELes Laboratoires Brothier S.A. Dec 2, 2019
K182819 — Decanting DeviceGcmedica Enterprise Ltd.(Wuxi) Dec 2, 2019
K190987 — Uroject12 Syringe LeverUrogen Pharma, Ltd. Dec 2, 2019
DEN180014 — WOUNDCHEK Bacterial StatusAlere Scarborough, Inc. Dec 2, 2019
K190588 — Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation Dec 2, 2019
K191088 — Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd. Dec 2, 2019
K190659 — Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed TipAllwin Medical Devices, Inc. Dec 2, 2019
K192666 — Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetPromisemed Hangzhou Meditech Co., Ltd. Dec 2, 2019
K191656 — ZipbondSdi Limited Dec 2, 2019
K191722 — Vital Navigation SystemZimmer Biomet Spine, Inc. Dec 2, 2019
K192394 — Hi-Fatigue Bone CementOsartis GmbH Dec 2, 2019
K190876 — mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling ClaimedMercator Medical (Thailand), Ltd. Dec 2, 2019
K192038 — Emprint Visualization ApplicationCovidien, LLC Dec 2, 2019
K192374 — Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam StripCardinal Health200, LLC Dec 2, 2019
K193040 — Resorbable Mesh DeviceSeaSpine Orthopedics Corporation Nov 30, 2019
K192782 — ASAHI CROSSWALK Peripheral Support CatheterAsahi Intecc Co., Ltd. Nov 29, 2019
K192105 — Innonix Antiviral Child's Face MaskInnonix Technologies Limited Nov 29, 2019
K192365 — Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc. Nov 29, 2019
K193034 — AXS Infinity LS Plus Long SheathStryker Neurovascular Nov 29, 2019
K190710 — EliA SymphonyS ImmunoassayPhadia AB Nov 29, 2019
K192186 — I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - NysragmographNeurolign USA, LLC Nov 29, 2019
K192468 — Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic CatheterHangzhou Bever Medical Devices Co., Ltd. Nov 27, 2019
K191673 — Upper Arm Blood Pressure MonitorFamidoc Technology Company Limited Nov 27, 2019
K192945 — 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application7D Surgical, Inc. Nov 27, 2019
K191032 — fMRI Hardware SystemNordicneurolab AS Nov 27, 2019
K190577 — World Knee Total Knee SystemsSignature Orthopaedics Pty, Ltd. Nov 27, 2019
K191987 — OrapeuticForward Science Nov 27, 2019
K192791 — Diagnostic Ultrasound SystemEdan Instruments, Inc. Nov 27, 2019
K192079 — EOSedgeEos Imaging Nov 27, 2019
K191911 — 3Shape Splint Design3Shape A/S Nov 27, 2019
K192438 — Rhythmia HDxTM Mapping SystemBoston Scientific Corporation Nov 27, 2019
K190811 — Optimus NEURO System - Sterile KitOsteonic Co., Ltd. Nov 27, 2019
K191428 — ECG CableShenzhen Changke Connect Electronics Co., Ltd. Nov 27, 2019
K190955 — Hypotension Decision AssistDirected Systems, Ltd. Nov 27, 2019
K192519 — Multi-modality workstationBeijing Superlaser Technology Co., Ltd. Nov 27, 2019
K192379 — Hi-Fatigue G Bone CementOsartis GmbH Nov 27, 2019
K191961 — OrthoGoldTissue Regeneration Technologies Nov 26, 2019
K192376 — Simplexa VZV Swab Direct, Simplexa VZV Positive Control PackDiasorin Molecular, LLC Nov 26, 2019
K192367 — Ion Endoluminal SystemIntuitive Surgical, Inc. Nov 26, 2019
K191426 — FiberTak ButtonArthrex, Inc. Nov 26, 2019
K192764 — NeuroOne Cortical ElectrodeNeuroone, Inc. Nov 26, 2019
K192417 — ARIX Cannulated Screw SystemJeil Medical Corporation Nov 26, 2019
K192271 — Access PCT, Access PCT CalibratorsBeckman Coulter, Inc. Nov 26, 2019
K192745 — DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. Nov 26, 2019
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