FDA 510(k) clearances — page 354
clearances on record, most recent first.
Clearances — page 354
35,301–35,400 of 176,542- K143020 — LiverMultiScan
- K143438 — Flowtron ACS900
- K143476 — Digi-One
- K150002 — iNSIGHT Color Doppler Ultrasound System
- K150218 — Fill-Up!
- K150696 — Jade 37% Phosphoric Acid Etchant Gel
- K150783 — Progressive Orthopaedic Total Knee System
- K150796 — Dental Bone Cutting Instruments
- K150868 — Solana GAS Assay, Solana instrument
- K150981 — SMV Scientific Bone Screws
- K151103 — ASAHI Corsair Microcatheter
- K151192 — syngo.via MI Workflows
- K151221 — Kubtec DIGIVIEW 395
- K151272 — Henschke Titanium Applicator Set
- K151419 — GF50A
- K133070 — SURGICAL FACE MASK (Ear Loops and Tie-on)
- K141348 — VISCO SOFT CONTACT LENS
- K150540 — Instru-Safe Instrument Protection System
- K150666 — uNion Cervical Plate System
- K150879 — LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers
- K133995 — NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE
- K143513 — ZIO SR ECG Monitoring Service
- K143671 — Propeller Model 2014-D Sensor
- K143726 — XLR8 PLUS (XLR8+)
- K150074 — Elevate Moisturizing Spray
- K150257 — PreludeEASE Hydrophilic Sheath Introducer
- K150419 — miraDry System MD4000
- K150500 — Px PEEK IBF System
- K150559 — Life Fast Set, Life Regular Set
- K150781 — Tissue Removal Pouch
- K150895 — SPEC Model M16
- K151131 — PRECICE Intramedullary Limb Lengthening System
- K151230 — Arthrex FiberTak Anchors
- DEN130039 — BRAINPORT V100 DEVICE
- K142596 — Infusomat Space Volumetric Infusion Pump
- K142752 — Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360º Spinal Fixatoin System, Title 2 Polyaxial Spinal System
- K142797 — I.V. Catheter
- K143003 — iPulse Smooth Skin Gold Hair Removal System
- K150089 — NanoKnife System
- K150113 — Fusion Black Powder-Free Nitrile Exam Glove
- K150340 — POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue)
- K150369 — SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent Fusion (Classic or Flex Retention) with DentiTrac Micro-recorder
- K150623 — Nanova Flowable Composite
- K150758 — Safety Disposable Insulin Syringe
- K150967 — XIDF-AWS801, Angio Workstation, V6.10
- K151028 — LOGIQ e
- K151276 — DePuy Synthes T-PAL Ti Spacer
- K151356 — Spacemaker Pro Access and Dissector System
- K140836 — ZIBONE ZIRCONIA BLOCKS
- K141084 — Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix
- K141879 — BELIMED STEAM STERILIZER MST-H
- K142369 — Urinary Incontinence System
- K142898 — ABL800 FLEX with AQURE connectivity
- K142934 — CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved
- K143622 — dynaMX Compression Staple
- K150018 — VS3-IR-MMS System
- K150119 — PALACOS R pro
- K150312 — Vdrive system, Vdrive Duo, Vdrive with V-Sono
- K150512 — STAR 90
- K150667 — True Dilatation Balloon Valvuloplasty Catheter
- K150709 — ProTrack RF Anchor Wire
- K150721 — ARDO Calypso Pro Powered Breast Pump
- K150727 — ESTECEM
- K150920 — truFreeze System
- K150994 — NuVasive CoRoent Thoracolumbar Implants
- K150996 — AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip
- K141919 — VEINOPLUS SPORT NEUROMUSCULAR STIMULATOR
- K142480 — OsteoCool V-2 RF Ablation System
- K150231 — Navigated Disc Prep Instruments and CAPSTONE Trials
- K150535 — Cavitron Touch Ultrasonic Scaling System
- K150719 — OARtrac System with Skin Sensors
- K150730 — Zimmer PSI Shoulder System
- K150882 — Edwards Suture Fastening System
- K140790 — Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)
- K142751 — Chang Gung ComMed Series Dental Implant System
- K143090 — LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUID
- K150184 — Dymaxeon Spine System
- K150199 — Neodent Implant System
- K150303 — XXL Vascular Balloon Dilatation Catheter
- K150630 — Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV Aspheric ( methafilcon A) Soft (hydrophilic) Contact lens for Daily Wear
- K141943 — BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM
- K142416 — Luma Wrap
- K142598 — Opto Wire and OptoMonitor System
- K142626 — Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set, Y-connector, Drain Adaptor, Invia Liberty Canisters
- K142679 — CARESCAPE R860
- K142783 — HEARTWAY Electrically Powered Wheelchair P27
- K142835 — Iliad Pedicle Screw System and Zenius Pedicle Screw System
- K150080 — DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S
- K150319 — MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS
- K150376 — Sonoma Cancellous Bone Screw and Washer
- K150378 — NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook
- K150414 — Midas Touch-Nitrile Examination Gloves- Powder free, Orange, XS, Model SNAEFT-240OR-XS +1 more
- K150415 — NilRead
- K150496 — Total Knee Arthroplasty System
- K150582 — Vertaplex® High Viscosity (HV) Radiopaque Bone Cement
- K150616 — Trevo XP ProVue Retriever (4x30mm)
- K150718 — Wi-3 HAL-RAR System
- K151238 — JUSHA-M23C LCD Monitor
- K141332 — Captiva Spine SmartLOX Cervical Plate System
- K142512 — Personalized Physiology Analytics Engine software
Data sourced from openFDA. This site is unofficial and independent of the FDA.