FDA 510(k) clearances — page 243
clearances on record, most recent first.
Clearances — page 243
24,201–24,300 of 175,699- 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
- K182501 — Hair Laser Headband
- K182753 — A6 OTC Pain Relief TENS
- K182767 — V2 OTC Pain Relief TENS
- K170723 — Swaive Thermometer SWT1A
- K173944 — Endocular Viewing Lenses and Silicone Ring
- K180258 — SpeediCath Standard
- K180688 — SLENDERTONE CoreFit Abs 8, Type 734
- K181116 — CONVIVO
- K181186 — Solitare Platinum Revascularization Device
- K181354 — 074 Zenith Flex System
- K181468 — Hybrid3D
- K181685 — Vivid E80, Vivid E90, Vivid E95
- K181902 — Codman Certas Plus Electronic Tool Kit
- K181936 — DyeVert PLUS EZ Contrast Reduction System
- K181947 — Persona Revision Knee System
- K182171 — SMV Scientific K-Wire and Pins
- K182464 — PeekMed
- K182706 — External upper limb tremor stimulator
- DEN180004 — picoAMH ELISA
- K173603 — Monarch Airway Clearance System
- K173756 — Certus 140 2.45GHz Ablation System
- K180275 — VAMP Optima closed blood sampling system
- K180302 — Guardia Access Malleable Obturator, Guardia Obturator, Soft-Pass Obturator, Soft-Trans Malleable Obturator, Guardia ETS Embryo-Tested Syringe, Flushing Catheter
- K180605 — GastroFlush
- K180758 — Osteocera Resorbable Bone Substitute
- K180788 — Gas Module 3
- K180940 — KODEX EPD System
- K181530 — World Total Knee System
- K181560 — Cios Alpha
- K181596 — Spine Wave Navigated Instruments
- K182140 — da Vinci Xi Surgical System, da Vinci X Surgical System
- K182281 — Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech
- K182318 — Retina Workplace
- K182322 — Duo Lumbar Interbody Fusion Device
- K182365 — TempSure System
- K182647 — GC70
- K172670 — BD Single Use, Hypodermic Syringe
- K173824 — Humeral Short Stem System
- K180046 — Masimo Rad-97 and Accessories
- K180622 — Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port
- K181964 — JiveX
- K182002 — Cumulus Remover
- K182042 — Randox Calcium (Ca)
Data sourced from openFDA. This site is unofficial and independent of the FDA.