510(k) Clearances in 2019 — Page 50

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 50 of 59)
510(k) clearancesDetails
K190184 — iSLEEVE Introducer SetBoston Scientific Mar 7, 2019
K182870 — Introcan Safety 3 Closed IV CatheterB.Braun Medical, Inc. Mar 7, 2019
K190055 — Duo Lumbar Interbody Fusion DeviceSpineology, Inc. Mar 7, 2019
K182413 — Electric Breast PumpGuangdong Horigen Mother & Baby Products Co., Ltd. Mar 7, 2019
K180880 — DARI HealthScientific Analytics, Inc. Mar 7, 2019
K183078 — VitalConnect Platform, VitalPatch BiosensorVitalconnect, Inc. Mar 7, 2019
K181682 — VISULAS greenCarl Zeiss Meditec, AG Mar 6, 2019
K181859 — Visualase Thermal Therapy SystemMedtronic Navigation, Inc. Mar 6, 2019
K181807 — Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device)Micro Therapeutics, Inc. D/B/A Ev3 Neurovascular Mar 6, 2019
K182966 — PLANET Onco DoseDosisoft Mar 6, 2019
K183201 — Hearing Healthcare ProDb Diagnostic Systems, Inc. Mar 6, 2019
K183289 — ClearGrasp SnareFinemedix Co., Ltd. Mar 6, 2019
K183397 — ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP Mar 6, 2019
K183366 — GenePOC Strep AGenepoc, Inc. Mar 6, 2019
K182173 — Joule SystemSciton, Inc Mar 6, 2019
K183053 — Olympus Small Intestinal Capsule Endoscope SystemOlympus Medical Systems Corp. Mar 5, 2019
K181656 — ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color)Eyemed Technologies S.R.L. Mar 5, 2019
K182628 — Imagio Ultrasound Imaging SystemSeno Medical Instruments, Inc. Mar 5, 2019
K183172 — Stryker SternalPlate SystemStryker Mar 5, 2019
K190030 — Embrella Endoscopic Distal AttachmentMicro-Tech (Nanjing) Co., Ltd. Mar 5, 2019
K180842 — MAC Medical D-Series Blanket and Solution Warming CabinetsMac Medical, Inc. Mar 5, 2019
K183384 — JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal LubricantUnited Consortium Mar 4, 2019
K183453 — VS3-IRMedtronic Mar 4, 2019
K181843 — MLP Special Locking Bone Plate SystemMaxxion Medical, LLC / Baumer SA Mar 4, 2019
K182225 — Dimension Vista High-Sensitivity Troponin I (TNIH) AssaySiemens Healthcare Diagnostics, Inc. Mar 4, 2019
K190322 — SCARLET® AC-T Secured Anterior Cervical CageSpineart Mar 4, 2019
K190193 — SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc. Mar 4, 2019
K181782 — Medline Reinforced Epidural CatheterMedline Industries, Inc. Mar 4, 2019
K182495 — Electronic Blood Pressure MonitorShenzhen Jumper Medical Equipment Co., Ltd. Mar 3, 2019
K183067 — Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. Mar 1, 2019
K181932 — DTX Studio designNobel Biocare AB Mar 1, 2019
K181730 — BD Vacutainer Eclipse UltraFill Blood Collection NeedleBecton, Dickinson And Company Mar 1, 2019
K180050 — CurvaFix Intramedullary Rodscrew SystemCurvafix, Inc. Mar 1, 2019
K190234 — ODI HD Dental SensorCnd Global Technologies, Inc. Mar 1, 2019
K181788 — Lead-free Chemical Indicators for Steam SterilizationKem Medical Products Corp. Mar 1, 2019
K182710 — Fetal Doppler, Model FD88Shenzzhen Luckcome Technology Inc., Ltd. Mar 1, 2019
K181475 — DxH 520 Hematology InstrumentBeckman Coulter Mar 1, 2019
K183705 — IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. Mar 1, 2019
K182822 — Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. Mar 1, 2019
K183147 — BrackFixVoco GmbH Mar 1, 2019
K180852 — Manual WheelchairJiangyin Newrise Medical Equipment Co., Ltd. Mar 1, 2019
DEN180021 — Early Bird Bleed Monitoring SystemSaranas, Inc. Mar 1, 2019
K173793 — XactTrace Single Use Respiratory Effort Belt SystemEmbla Systems Mar 1, 2019
K190007 — Vydence Laser FamilyVydence Medical Industria E Comercio Ltda Mar 1, 2019
K183478 — ClearON MobileRayence Co., Ltd. Mar 1, 2019
K183401 — Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation Mar 1, 2019
K183702 — Polar Care WaveBreg, Inc. Mar 1, 2019
K181871 — EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG ImmunoassayPhadia AB Mar 1, 2019
K183266 — EP-TRACER SystemSchwarzer Cardiotek GmbH Mar 1, 2019
K183402 — PRO-LITE Sterilization TraySTERIS Corporation Mar 1, 2019
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