510(k) Clearances in 2018 — Page 51

3,062 510(k) clearances total

Browse FDA 510(k) clearances granted in 2018. RegDataLab tracks 3,062 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2018 (page 51 of 62)
510(k) clearancesDetails
K173323 — AnastoClip GC Closure SystemLeMaitre Vascular, Inc. Mar 8, 2018
K180086 — Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation CatheterGyrus Acmi, Inc. Mar 8, 2018
K172115 — Navigated Instrument SystemOrthofix, Inc. Mar 8, 2018
K172892 — Neuro Assessment System NAS-1000Headsense Medical, Inc. Mar 8, 2018
K173625 — syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc. Mar 8, 2018
K173075 — ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)Dxnow, Inc. Mar 8, 2018
K180171 — PillCam Patency SystemGiven Imaging , Ltd. Mar 8, 2018
K173605 — iQMRMedic Vision - Imaging Solutions, Ltd. Mar 8, 2018
K173777 — BreathID Hp Lab SystemExalenz Bioscience , Ltd. Mar 8, 2018
K173440 — Carriere SLX 3D ClearOrtho Organizers, Inc. Mar 8, 2018
K180044 — SIROLaser BlueDentsply Sirona Mar 8, 2018
K180135 — THD Anopress with THD SensyProbeThd Spa Mar 8, 2018
K173713 — HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. Mar 8, 2018
K173772 — BreathID Hp SystemExalenz Bioscience , Ltd. Mar 8, 2018
K180105 — Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump CanisterPenumbra, Inc. Mar 8, 2018
K180335 — Accutension Smartphone Auscultatory BloodShanghai Hulu Devices Co., Ltd. Mar 8, 2018
K173769 — DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring LiquidDmax Co., Ltd. Mar 8, 2018
K173249 — CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc. Mar 8, 2018
K171320 — ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION ScrewsMeril Healthcare Pvt. , Ltd. Mar 8, 2018
K173500 — NMF004AGC America, Inc. Mar 8, 2018
K180326 — icobrainIcometrix Mar 8, 2018
K171802 — ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)Bayer Healthcare, LLC Mar 7, 2018
K180350 — Dornier Medilas H Solvo 35 LaserDornier Medtech America Mar 7, 2018
K172818 — LMT-3000Lameditech Co. , Ltd. Mar 7, 2018
K171939 — ALVUE Balloon Dilation SystemGlobus Medical, Inc. Mar 7, 2018
K180156 — SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc. Mar 7, 2018
K172758 — Rotatable Snares, Non-Rotatable SnaresZhejiang Chuangxiang Medical Technology Co., Ltd. Mar 7, 2018
K172810 — PORT-X IVGenoray Co., Ltd. Mar 7, 2018
K180321 — Aesculap Optilene Nonabsorbable SutureAesculap, Inc. Mar 7, 2018
K171810 — Cone Tip Ureteral Catheter, Rutner Universal Wedge CatheterCook Incorporated Mar 7, 2018
K173114 — primeMidline CathetersPfm Medical, Inc. Mar 7, 2018
K180196 — On Call Express Mobile Blood Glucose Monitoring SystemACON Laboratories, Inc. Mar 7, 2018
K171750 — Citric Complete Dry Citric Acid (45X)Dimesol USA, LLC Mar 6, 2018
DEN170046 — 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)23AndMe, Inc. Mar 6, 2018
K173262 — Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound CatheterInnovative Health, LLC Mar 6, 2018
K173494 — OrthoSteady G Bone CementG21, S.R.L. Mar 6, 2018
K172267 — IRENE Thoracolumbar Fixation SystemTianjin Zhengtian Medical Instrument Co., Ltd. Mar 6, 2018
K173356 — Ingenia Elition S and Ingenia Elition X R5.4Philips Medical Systems Nederland B.V. Mar 6, 2018
K172381 — Digitimer DS7AP Constant Current StimulatorDigitimer , Ltd. Mar 6, 2018
K173879 — MiniMed Mio Advance infusion setUnomedical A/S Mar 5, 2018
K173741 — Reprocessed ArthoCare Ablation WandRenovo, Inc. Mar 5, 2018
K172663 — Cytology BrushMicro-Tech (Nanjing) Co., Ltd. Mar 5, 2018
K173942 — Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy DrugsCentral Medicare Sdn Bhd Mar 5, 2018
K172062 — AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test TrayMedscience Science Research Group, Inc. Mar 5, 2018
K173453 — Valeo® C+CSC with Lumen Interbody Fusion DeviceAmedica Corp. Mar 5, 2018
K172872 — DePuy Synthes Femoral Neck SystemDePuy Synthes Mar 5, 2018
K171715 — HammerTube SystemParagon 28 Mar 5, 2018
K173723 — EMPOWR Universal Tibial BaseplateEncore Medical L.P. Mar 5, 2018
K180334 — LEGION Knee SystemSmith & Nephew, Inc. Mar 5, 2018
K173731 — SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031)CooperSurgical, Inc. Mar 2, 2018
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