FDA 510(k) clearances — page 319
clearances on record, most recent first.
Clearances — page 319
31,801–31,900 of 176,542- K161251 — CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests
- K162189 — ANAX 5.5 Spinal System
- K152931 — Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator
- K153706 — Insulin Pen Needle
- K160597 — INDEPENDENCE MIS Spacers
- K160626 — ATLANTIS Abutment for HIOSSEN ET implant
- K161108 — Arthrex VaultLock Glenoid
- K161211 — Digital Thermometer
- K161311 — USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL cup, USP Sterile Water, 100 mL,250 mL and 500 mL bottles, USP Sterile Normal Saline (0.9% sodium chloride), 100 mL, 250 mL and 500 mL bottles
- K161532 — Philips Avent Comfort Single/Twin Electric Breast Pump
- K161570 — Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large
- K161619 — Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems
- K161777 — BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems
- K162119 — UreTron PF Series Probe
- K150830 — CompleClear Plastic Orthodontic Bracket and Wire Appliance
- K152197 — Skypro, SP01 Mask
- K152642 — LCCS Disposable RF Electrode, LCCS Reusable RF Electrode
- K153509 — GPS Angled Abutment
- K153559 — OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System
- K160106 — LUNA DENTAL IMPLANT SYSTEM
- K160253 — Vitalograph Model 6300 micro
- K160600 — Freedom Spinal Cord Stimulator System
- K160615 — ORTHODONTIC CERAMIC BRACKETS 1.1
- K160797 — FMX314 Surgical Platform
- K160943 — Bite Away
- K161030 — ATLANTIS Abutment for CONELOG implant
- K161124 — EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear
- K161503 — ORION
- K161545 — Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant
- K162094 — RS80A Diagnostic Ultrasound System
- K152659 — V10
- K153494 — HQS Introducer (Model 2064-HQS)
- K153560 — Optilite Low Level Albumin Kit
- K153731 — LifeFlow Rapid Infusion Device (LifeFlow Device)
- K160379 — Exufiber Ag+
- K160455 — AneurysmFlow
- K160650 — LIAISON HAV IgM, LIAISON Control HAV IgM
- K160764 — AirLife Autofill Humidification Chamber
- K161126 — ASAHI Corsair Pro
- K161189 — Integra TITAN Reverse Shoulder System
- K161195 — Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)
- K161230 — NuVasive Lumbar Interbody Implants
- K161355 — invendoscopy E200 System
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.