510(k) Clearances in 2019 — Page 56

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 56 of 59)
510(k) clearancesDetails
K182907 — SPY Elite Intraoperative Perfusion Assessment SystemNovadaq Technologies Ulc. (Now A Part Of Stryker) Jan 23, 2019
K182894 — HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. Jan 22, 2019
K182837 — M.U.S.T. Mini ExtensionMedacta International S.A. Jan 22, 2019
K183671 — LG PRA.L DERMA LED MASKLg Electronics.Inc Jan 22, 2019
K182955 — EZStart Interference ScrewConmed Corporation Jan 22, 2019
K182574 — Freedom Ultra-Congruent CR Tibial LinerMaxx Orthopedics, Inc. Jan 22, 2019
K180767 — FEMON Banana ThermometerLife Science Technology, Inc. Jan 22, 2019
K182970 — EUROPA™ Pedicle Screw SystemMiRus, LLC Jan 22, 2019
K183685 — O-ScanEsaote, S.P.A. Jan 22, 2019
K183553 — Compress and Mini Compress Anti-Rotation SpindlesBiomet, Inc. Jan 22, 2019
K183636 — SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital ControllerBoston Scientific Corporation Jan 22, 2019
K181887 — AMD Anti-Fog SolutionAdvanced Medical Design Co., Ltd. Jan 22, 2019
K182193 — S-LineBiocetec Co., Ltd. Jan 22, 2019
K182507 — Tigon Medical Tissue AnchorsTigon Medical Jan 21, 2019
K183357 — XableCath Crossing CatheterXablecath, Inc. Jan 21, 2019
K183581 — Codman Disposable PerforatorsIntegra Lifesciences Corp. Jan 20, 2019
K182527 — ELAN 4 ToolsAesculap, Inc. Jan 19, 2019
K182784 — MUTYH-Associated Polyposis (MAP)23AndMe, Inc. Jan 18, 2019
K180236 — VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)Vr Medical Technology Co., Ltd. Jan 18, 2019
K181099 — Bright GuardKoncept Innovators, LLC Jan 18, 2019
K182951 — Pristina Serena 3DGE Healthcare Jan 18, 2019
K183254 — Magnetom VidaSiemens Medical Solutions USA, Inc. Jan 18, 2019
K183298 — HardyDisk AST Omadacycline 30µg (OMC30)Hardy Diagnostics Jan 18, 2019
K181126 — Reprocessed Visions PV .035 Digital IVUS CatheterInnovative Health, LLC Jan 18, 2019
K182518 — AHMED ClearPath Glaucoma Drainage DeviceNew World Medical, Inc. Jan 18, 2019
K183231 — SIGNA PremierGe Medical Systems, LLC Jan 18, 2019
K183264 — Flex-THOR scopeKARL STORZ Endoscopy-America, Inc. Jan 18, 2019
K181895 — Kurin PIV Blood Collection Set with High PressureKurin, Inc. Jan 18, 2019
K181084 — PENTAX Video Colonoscopes (EC Family)Pentax Of America, Inc. Jan 18, 2019
K182782 — DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal ToricAlcon Laboratories, Inc. Jan 18, 2019
K182211 — Aurora Surgiscope SystemRebound Therapeutics Corporation Jan 18, 2019
K182323 — PICO 7Y Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited Jan 18, 2019
K181097 — Cook Cystostomy Catheter SetCook Incorporated Jan 18, 2019
K181076 — Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC Jan 18, 2019
K183224 — SureForm 45, SureForm 45 ReloadsIntuitive Surgical Jan 18, 2019
K182284 — Tyber Medical PT Interbody SpacerTyber Medical, LLC Jan 18, 2019
K182956 — Puffin Lite Infant Resuscitation SystemInternational Biomedical Jan 18, 2019
K182620 — MRI Compatibility for Existing Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A. Jan 18, 2019
K181190 — Pinehurst Anterior Cervical Plate SystemSignature Orthopaedics Pty, Ltd. Jan 17, 2019
K183060 — CervAlign™ Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) Jan 17, 2019
K182111 — DL Self-adhesive ElectrodeShaoxing DL Healthcare Co., Ltd. Jan 17, 2019
K181338 — Imboki Knee Instrument SystemSignature Orthopaedics Pty, Ltd. Jan 17, 2019
K183538 — VIVA combo RF SystemStarmed Co., Ltd. Jan 17, 2019
K181302 — Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. Jan 17, 2019
K182456 — Study WatchVerily Life Sciences, LLC Jan 17, 2019
K180779 — Savina 300Dragerwerk AG & CO Kgaa Jan 17, 2019
K182010 — ProgenaMatrixCell Constructs I, LLC Jan 17, 2019
K182227 — Esprit NovaNeurozone Msh Incorporated Jan 17, 2019
K182651 — HbA1c AdvancedBeckman Coulter Ireland, Inc. Jan 16, 2019
K180410 — Dosis SAMDosis, Inc. Jan 16, 2019
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