FDA 510(k) clearances — page 346
clearances on record, most recent first.
Clearances — page 346
34,501–34,600 of 175,770- K142814 — Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial
- K142830 — Ophthalmed Bending Laser Probes
- K143437 — Droplet Pen Needles
- K143505 — Zimmer Patient-Specific Abutment, Internal Hex, Titanium
- K143604 — Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic Catheters
- K150538 — Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/Divider
- K150951 — aeris Balloon Dialation Catheter
- K150975 — Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2 multi-msrmt-modules for use with IntelliVue patient monitors
- K151214 — ALIF Interfixated System
- K151398 — K-Pack II Needle - 29G x 5/16 Thin Wall
- K151509 — GSI TympStar Pro Middle Ear Analyzer
- K120577 — MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DX
- K133075 — Plus Surgical Gowns (EO Sterilized), PMGB-XXX
- K133080 — Plus Surgical Drapes (EO Sterilized), PMDB-XXX
- K143093 — 0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm)
- K143110 — GALAXY MIS Screw System
- K150029 — Habib EUS RFA
- K150053 — STALIF C; STALIF C-Ti
- K150766 — Carestream DRX-1 System
- K151031 — Virage OCT Spinal Fixation System
- K151161 — VICTUS Femtosecond Laser Platform
- K151178 — VariAx 2 Wrist Fusion System
- K151387 — Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade
- DEN140018 — ESOPHAGEAL COOLING DEVICE
- K142548 — MIDSLEEVE
- K142786 — Ontex Unscented Tampons with Colored Plastic Applicators
- K142834 — DiscoverEEG System, Model DE-401
- K142912 — Merits Yoga Power Scooter, S542
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.