FDA 510(k) clearances — page 311
clearances on record, most recent first.
Clearances — page 311
31,001–31,100 of 175,699- K161376 — DragonFly Surgical Drill System
- K161513 — Anti-Borrelia burgdorferi US Westernblot (IgG)
- K161516 — G Surgical Marksman MIS System
- K160646 — XYcor® Expandable Spinal Spacer System
- K160802 — Infrared Forehead Thermometer, FT-100A
- K160983 — Kyphon HV-R Bone Cement
- K161130 — ResolutionMD
- K161196 — SOMATOM Drive
- K161313 — ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology
- K161772 — FFRct
- K153476 — KATANA AVENCIA Block
- K153571 — Cavilon Advanced High Endurance Skin Protectant
- K160632 — Vantage Titan 1.5T, MRT-1510, V3.6 Software
- K160702 — ZION Anterior Cervical Fixation System
- K161092 — GalaSHAPE 3D
- K161331 — HyperSound Tinnitus Module
- K161615 — Accurett
- K161663 — sTMS mini
- DEN150037 — ImPACT Computerized Neurocognitive Concussion Management Aid
- K151458 — Double Medical Universal Spine System
- K153514 — Premium Plus C01/C02 LED Curing Light
- K160011 — H-Max S stem
- K161098 — ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color)
- K161498 — Streamline OCT Occipito-Cervico-Thoracic System
- K161766 — PathLoc-L MIS Spinal System
- K162074 — Werewolf RF20000 Controller, FLOW 50 Wand
- K153278 — Wireless Smart Gluco-Monitoring System
- K153286 — iHealth Align Gluco-Monitoring system
- K153347 — Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit
- K153364 — Kerecis SecureMesh
- K153470 — MADgic Laryngo-Tracheal Mucosal Atomization Device
- K160329 — InMode System MiniFX Handpiece
- K160366 — Electrosurgical disposable grounding pads
- K161034 — Microcyn Plus Wound Care Solution
- K161249 — Streamline 6495 Bipolar Temporary Myocardial Pacing Lead
- K161287 — DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak
- K161405 — Valeo II Interbody Fusion Device System
- K162030 — 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle
- K152091 — Fingertip Pulse Oximeter
- K152390 — Medke Oximetry Finger Sensor
- K153397 — S-Wire Guidewire System
- K153440 — PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set
- K153651 — Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems
- K161105 — Reprocessed Compression Garments
- K161315 — Vein Clamps, Artery Clamps
- K161375 — Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit
- K161402 — Bullfrog Micro-Infusion Device
- K162045 — SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System
- K162052 — Sentinella 102, Sentinella 102 Horus
- K152089 — Wrist Pulse Oximeter
- K152126 — UST-5550-R; UST-5536-R; L43K
- K152289 — Alians Elbow Locking Plating System
- K152949 — WebPAX
- K160022 — LUOFUCON Silicone Ag foam dressing
- K160075 — Accent XL
- K160612 — Sumitomo Proton Therapy System
- K160766 — Ambu USR, Ambu M
- K160793 — First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)
- K161019 — Uroview FD
- K161385 — Just Like Me Personal Lubricant
- K161396 — SPEC Model M23
- K161518 — PACS CORE/ENCORE
- K161748 — SUPRIA w/guideShot Option
- K161403 — A.R.C. Laser Surgical Fibers and Probes
- K161445 — PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C
- K161502 — MC1 Plus
- K161933 — The Braun ThermoScan® 3 High Speed Compact Ear Thermometer
- K152125 — Oral Surgery System and Accessories
- K153478 — Sydney IVF Gamete Buffer
- K161037 — Tarsa-Link Stand-Alone Wedge Fixation System
- K161171 — PressureWire X Guidewire
- K161182 — Solana Trichomonas Assay
- K161292 — Distal Radius Plating System
- K162196 — Dell UP3216Q with QUBYX PerfectLum bundle
- K153089 — 'cottony' II TAPE, PLEDGETS
- K153285 — EMS-200
- K153297 — Perifix and Contiplex Catheter
- K153308 — EUROIMMUN Anti-West Nile Virus ELISA (IgM)
- K153375 — ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls
- K160331 — LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable Clamp
- K160592 — SUPERCATH 6
- K160840 — ECG100+, ECG200+
- K161210 — RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems
- K161269 — CELTRA Press
- K161324 — Raycell Mk2
- K161661 — Thermi RF Accessories
- K152890 — SACCADOMETER PLUS, SACCADOMETER ADVANCED
- K153283 — VivoSight Dx Topical OCT System
- K153452 — Salto XT, Salto Talaris
- K153573 — Converge
- K160138 — Adhesive Electrodes
- K160382 — OT EQUATOR
- K161266 — Athena Breast Pump
- K161267 — Response BandLoc Spinal Fixation
- K161336 — VSI StraitSet micro-introducer kit
- K161574 — Discovery MI
- K161622 — LensGiene Sterile Saline Solution
- K161791 — Aer-O-Scope Colonoscope System
- K162075 — NICO TRIOwand
- K162077 — Laparoscopic Spray Applicator with Spinning Luers
Data sourced from openFDA. This site is unofficial and independent of the FDA.