FDA 510(k) clearances — page 251
clearances on record, most recent first.
Clearances — page 251
25,001–25,100 of 176,542- K181934 — Vivid T8, Vivid T9
- K181939 — icobrain
- K182216 — Merit Syringe
- K182279 — Merit Syringe
- K182425 — Universal Mesh - Sterile
- K182442 — MiniGuard Arterial Safety Valve
- K182444 — ERBEFLO Olympus Scope Port Connector
- K182451 — BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
- K180801 — Actreen Hi-Lite Cath, Actreen Hi-Lite Set
- K181258 — ConnectedOR Hub with Device and Voice Control
- K181288 — Athelas One
- K181781 — DynaClipTM Bone Staple
- K182095 — Tina-quant Transferrin ver.2 (urine application)
- K182160 — 1688 Camera Control Unit +4 more
- K182559 — PREMIER Platinum HpSA PLUS
- DEN170056 — Parathyroid Detection (Model PTeye) System
- DEN170092 — Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System
- K180180 — HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)
- K180253 — Sheridan Endobronchial Tubes
- K180415 — Invia White Foam NPWT
- K180601 — Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)
- K180786 — Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff
- K181195 — ClearPoint System
- K181208 — Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter
- K181403 — Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR
- K181501 — Afina
- K181639 — Panta 2 Arthrodesis Nail System
- K181837 — Spinal Elements Ti-Bond coated devices
- K181911 — Interlude 100% Cotton Tampon
- K182077 — Mazor X System (Mazor X Stealth Edition)
- K182096 — Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs
- K182104 — NavLock Trackers, Robotic Reference Frame
- K182110 — CDI Blood Parameter Monitoring System 550
- K182121 — CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition
- K182127 — Wrist Blood Pressure Monitor Model BP6100
- K182270 — Cellene CO2 Laser System
- K182405 — Dexcom Pro Q Continuous Glucose Monitoring System
- K182427 — Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System
- K182557 — MTS Eravacycline 0.002 - 32 µg/mL
- K182596 — Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System
- K182616 — NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
- K182823 — PRODENSE Bone Graft Substitute
- K180247 — DAEHAN Adhesive Surface Electrodes
- K180310 — DePuy Synthes Trauma Orthopedic Plates and Screws
- K180363 — Clear-Tip EUS-FNA
- K181049 — Spectra Optia Apheresis System
- K181266 — Implantswiss Dental Implant System, Implantswiss Dental Abutment System
- K181273 — GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System
- K181820 — Medline Unite Mini Plates and Screws
- K182098 — N Latex FLC kappa assay, N Latex FLC lambda assay
- K182273 — MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT
- K182276 — MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit
- K182523 — Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens
- DEN180028 — 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
- K171199 — AVIEW
- K171585 — LUXEN Zr, LUXEN Smile
- K173351 — Panpac Flexi Shelf Pessary
- K180735 — Endomat Select
- K180899 — Universal Base Abutment
- K181553 — Immunalysis Ethyl Alcohol Enzyme Assay
- K181994 — Single Use Aspiration Needle NA-U201H
- K182082 — Tumark for Eviva, Tumark for Brevera
- K182085 — Balanced Knee Revision System Trabecular Tibial Cone Augments
- K182087 — DynaMesh-POSTERIOR
- K182088 — XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro
- K182588 — Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider
- K182679 — Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1
- K182880 — Halifax Imaging Kit
- K180354 — UroGen Ureteral Catheter
- K180718 — ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES
- K181488 — LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier
- K181550 — Cios Spin
- K182062 — Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device
- K182063 — VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System
- K182066 — O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set
- K182072 — VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides
- K182381 — Wilson-Cook Mini Basket
- K182392 — Frozen C
- K182466 — AOS Calcaneal Plating System
- K182540 — DiLumen Endolumenal Interventional Platform
- K180020 — HemoScreen Hematology Analyzer
- K180559 — HSV 1 & 2 ELITe MGB Kit; ELITe InGenius
- K181239 — Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer
- K182215 — ClearLink Controlled Phototherapy Equipment
- K182914 — MC3 Vascular Access Kit 21030
- K180980 — ORTHROS Posterior Stabilization System; ORTHROS MIS Posterior Stabilization System
- K181458 — Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter
- K170732 — Biomate Dental Implant System
- K173965 — Implant Planning Software
- K180285 — PENTAX Medical Video Colonoscope EC34-i10T Series
- K180286 — Polyethylene Catheter
- K180291 — Cook Silicone Balloon HSG Catheter
- K180300 — Margolin HSG Cannula, Goldstein Sonohysterography Catheter
- K180487 — Peak.me
- K181031 — TSI Transseptal Introducer
- K181739 — Invisalign System with Mandibular Advancement Feature
- K181898 — Two-Step Implant System
- K182041 — Dexcom G6 Glucose Program Continuous Glucose Monitoring System
- K182177 — Accipiolx
- K182299 — MAGNETOM Aera
Data sourced from openFDA. This site is unofficial and independent of the FDA.