510(k) Clearances in 2019 — Page 34

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 34 of 59)
510(k) clearancesDetails
K190414 — Moss Gastrostomy Tube, Moss Nasal Tube – Mark IVMoss Tubes, Inc. Jun 14, 2019
K191387 — ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding TubeEnvizion Medical , Ltd. Jun 14, 2019
K190700 — ELECTRODES PADShenzhen Bestpad Technology Development Co., Ltd. Jun 14, 2019
K183219 — Trio-CT Triple Lumen CatheterMedical Components, Inc. (Dba MedComp) Jun 14, 2019
K190172 — Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsStryker Jun 14, 2019
K183431 — Medline Digital Rectal Thermometer SheathMedline Industries, Inc. Jun 14, 2019
K191318 — AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc. Jun 14, 2019
K183263 — UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier EnvelopeUnipack Medical Corporation Jun 14, 2019
K190424 — HealthICHZebra Medical Vision, Ltd. Jun 13, 2019
K191005 — ProLift® Expandable SystemLife Spine, Inc. Jun 13, 2019
K190117 — Fiberoptix IABArrow International, Inc. Jun 13, 2019
K183564 — Electrosurgical GeneratorFulwell, LLC Jun 13, 2019
K190667 — Sonopet iQ Sterilization TrayParagon Medical Jun 13, 2019
K191036 — SyMRISyntheticmr AB Jun 13, 2019
K190133 — Full Automatic (NIBP) Blood Pressure Monitor-HL158UBHealth & Life Co., Ltd. Jun 13, 2019
K183363 — Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc. Jun 13, 2019
K181965 — Restore ToothpasteDr. Collins, Inc. Jun 13, 2019
K183460 — ClariCT.AIClaripi, Inc. Jun 13, 2019
K190228 — Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd. Jun 13, 2019
K182159 — Strome-Blitzer Cytology BalloonAdn International, LLC Jun 13, 2019
K191089 — Edwards Pressure CableEdwards Lifesciences, LLC Jun 13, 2019
K182608 — Oyster ACIF CageSilony Medical GmbH Jun 13, 2019
K191341 — Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management BagsCorinth Medtech, Inc. Jun 13, 2019
K181514 — SeraQuest HSV Type 2 Specific IgGQuest International, Inc. Jun 13, 2019
K183513 — XenoSure Dura Biologic PatchLeMaitre Vascular, Inc. Jun 13, 2019
K190422 — Viveve System 2.0Viveve Medical Jun 12, 2019
K183692 — Avid IF2Vision Quest Industries Inc./Dba VQ Orthocare Jun 12, 2019
K180511 — Eon FRDominion Aesthetic Technologies, Inc. Jun 12, 2019
K183046 — Aquilion ONE (TSX-305A/6) V8.9 with AiCECanon Medical Systems Corporation Jun 12, 2019
K183691 — PENTAX Medical ENT Video Imaging SystemPentax Of America, Inc. Jun 12, 2019
K191115 — RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. Jun 12, 2019
K191038 — On Call Express Voice Blood Glucose Monitoring SystemACON Laboratories, Inc. Jun 12, 2019
K191291 — Wallace Dual Lumen Oocyte Recovery SystemCooperSurgical, Inc. Jun 12, 2019
K183335 — Medline Poly-Cath Red Polymer Urethral CatheterMedline Industries, Inc. Jun 12, 2019
K190177 — J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,Ranfac Corporation Jun 12, 2019
K191055 — HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. Jun 12, 2019
K191064 — Argon HandsetNew Deantronics Taiwan , Ltd. Jun 12, 2019
K190185 — Phasix ST Mesh with Open Positioning SystemC.R. Bard, Inc. Jun 12, 2019
K190016 — Lateral Plate SystemCorelink, LLC Jun 12, 2019
K190521 — Aequalis Ascend Flex Shoulder SystemTornier S.A.S. Jun 12, 2019
K172232 — LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600Ams Diagnostics Jun 12, 2019
K191331 — Life Sensor Cardiac MonitorBraveheart Wireless, Inc. Jun 12, 2019
K182749 — Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast PumpLansinoh Laboratories Saglik Gerecleri Tasarim San. Tic., Ltd. Jun 12, 2019
K191271 — T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments SystemStryker Trauma GmbH Jun 11, 2019
K191226 — Arthrex SwiveLock Suture AnchorArthrex, Inc. Jun 11, 2019
K191268 — Force Fiber SutureTeleflex Medical Incorporated Jun 11, 2019
K182656 — JAMBRO Single Core A Sterilization wrapJiangsu Zhande Medical Supplies Co., Ltd. Jun 11, 2019
K191285 — Spine & Trauma NavigationBrainlab AG Jun 11, 2019
K182416 — NOVA Minimally Invasive SystemBaui Biotech Co., Ltd. Jun 11, 2019
K182713 — Scoreflex PTA Scoring Balloon CatheterOrbusneich Medical Trading, Inc. Jun 11, 2019
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