FDA 510(k) clearances — page 206
clearances on record, most recent first.
Clearances — page 206
20,501–20,600 of 176,479- K200546 — ZeeroMED View
- K200846 — Balteum Lumbar Plate System
- K200914 — Healix Compression Screw System
- K200933 — Syntec Non-Sterile Steinmann Pins System
- K201184 — Lascod Impression Materials
- K183110 — LIVIA
- K192887 — Revitive Medic Plus, Revitive Advanced 2
- K193185 — Anscare SIMO Negative Pressure Wound Therapy (NPWT) System
- K193228 — Hamilton-G5
- K193516 — Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1
- K200035 — Ultravision Visual Field Clearing System
- K200259 — Headless Compression Screw System
- K200871 — Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator
- K200417 — RIST Radial Access Catheter
- K200910 — BOSS Balloon Guide Catheter
- DEN180065 — OGmend Implant System
- DEN190026 — iTEAR Neurostimulator
- K192286 — FUJIFILM EP-6000 Video Processor
- K192295 — PDT-FACE
- K192405 — Image Guidance System for Radiotherapy
- K192540 — Kitazato ET Catheters
- K192633 — GUS831 Compressor Nebulizer
- K192656 — Optimized Positioning System (OPS) Insight
- K200173 — Stone Retrieval Balloon
- K200279 — ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine
- K200453 — NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC
- K200571 — PERLA® Posterior Occipito-Cervico-Thoracic Fixation System
- K200606 — O-Genesis Graft Delivery System
- K200870 — Carnation Ambulatory Monitor
- K200917 — Azurion R2.1
- K201004 — Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W
- K201012 — EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System
- K192169 — PulsioFlex Monitoring System with ProAQT Sensor
- K192246 — Biowy PICC Catheter S Kit
- K192290 — 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown
- K192350 — Medical Non-Ablative Fractional Laser Systems
- K193523 — ArthrexVIP Web Portal
- K200240 — Turbett Instrument Pod
- K200519 — CarboClear® II Pedicle Screw System
- K200523 — Biolign® Roto-Loc Cervical Plate System
- K200816 — SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices
- K200902 — ClickClean
- DEN180055 — CARPEDIEM System
- K191816 — M-Vizion Femoral Revision System Extension
- K191866 — GelPOINT Mini Advanced Access Platform
- K191992 — PELNAC Bilayer Wound Matrix
- K192097 — Exactech® Equinoxe® Stemless Humeral Components
- K192803 — da Vinci Xi Surgical System, da Vinci X Surgical System
- K193394 — Humeral Cup Stability & Humeral Cup 135/145o Stability
- K200327 — Evry
- K200807 — IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
- K192197 — Magicore II System
- K192498 — Single Use Injector
- K193213 — Vicks VNT200 No Touch Forehead Thermometer
- K193592 — Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants
- K200541 — Hive Stand-alone Anterior Lumbar Interbody System
- K200590 — VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)
- K200814 — Affixus(R) Natural Nail(R) System Humeral Nail
- K200863 — Tiger® Occipital-Cervical-Thoracic Spinal Fixation System
- K200867 — Implantswiss Dental Implant System and Implantswiss Dental Abutment System
- K200896 — Solstice CCI
- K193350 — Leadtek Fingertip Pulse Oximeter
- K193388 — GlassLok Kits, GlassLok Powder, GlassLok Liquid
- K193459 — Panther Stereotactic
- K200101 — WOLF Thrombectomy V System
- K200141 — Oxi-W System
- K200208 — Agape Warming Personal Lubricant
- K200254 — Mydriatic Hyperspectral Retinal Camera (MHRC-C1)
- K200533 — binx io CT/NG Assay and binx io CT/NG System
- K200594 — Capnostream 35 Portable Respiratory Monitor
- K200624 — Percutaneous Introducer
- K192834 — MECTA Sigma
- K200238 — ControlRad Sterile Cover
- K192068 — i-ED COIL
- K192786 — Gatekeeper Balloon Catheter
- K200007 — PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar
- K200581 — Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
- K190139 — Zircos-Com
- K191492 — Maxxi Position Sensor
- K192017 — Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate
- K192063 — PGDx elio tissue complete
- K192408 — Custodiol HTK Solution
- K192856 — MT One
- K193033 — GSI Audera Pro
- K193153 — SPIRA-C Integrated Fixation System
- K193636 — SeaSpine Reef TH System
- K200074 — O-arm O2 Imaging System
- K200245 — EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System
- K200397 — Single Use Biopsy Forceps FB-456D
- K200826 — Smith&Nephew VISIONAIRE Patient Matched Cutting Blocks
- K191308 — U-Aligner
- K192183 — RocaTub Ureteral Catheter
- K192230 — MF SAFECATH
- K192358 — Pressure Therapy System PT1003
- K192475 — NemoFAB
- K192644 — GM501 SpermAir and GM501 SpermActive
- K192807 — Duo-Flow Side x Side Double Lumen Catheter
- K193305 — DynaClip Bone Staple
- K200070 — ARx Spinal System
- K200167 — QuikClot Control+
Data sourced from openFDA. This site is unofficial and independent of the FDA.