FDA 510(k) clearances — page 217
clearances on record, most recent first.
Clearances — page 217
21,601–21,700 of 176,479- K192755 — Soli-Lite LG4 Galileo
- K192833 — Indigo Aspiration System
- K192873 — SX-One MicroKnife
- K192990 — Litho Evo
- K193018 — Surgical Direct Hand-held Laparoscopic Instruments
- K193116 — MRopen EVO
- K193230 — Ziehm Vision FD
- K193235 — Telepack +
- K193238 — Nexus DR Digital X-Ray Imaging System (with vSharp)
- K193269 — UroLift System (UL400)
- K193292 — Voyant 5mm Fusion Device, Voyant Maryland Fusion Device
- K182388 — Krystal Klear Aligners
- K183144 — uMC 560i
- K183676 — DentiqAir
- K190775 — The RHEA Vital Sign Vigilance System
- K190829 — Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)
- K190881 — Spinal Elements Navigated Instruments
- K190935 — EZER, Portable X-ray System
- K190939 — ZOLL Arrhythmia Management Sysyem
- K191305 — Hereaeus Poseidon Microcatheter
- K191314 — Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q
- K191643 — TK Sterile Hypodermic Needle
- K192044 — 4CIS Marlin PEEK ACIF Cage
- K192100 — Aveta Disposable Hysteroscope
- K192229 — Neodent Implant System- GM Titanium Base for Bridge
- K192313 — Halo One Thin-Walled Guiding Sheath
- K192410 — ZS3 and z.one pro Ultrasound Systems
- K192589 — Everyway OTC TENS/EMS Combination
- K192607 — LiteWalk
- K193001 — Albumin BCP
- K193004 — Monopolar Cord
- K182476 — Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads
- K190012 — OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid
- K190824 — Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 2m/7ft, Airway Gas Sampling Set, disposable, Infant, TPE, 2m/7ft, Airway Adapter with Luer Connector, Adult/Pediatric
- K191087 — IntraMarX Radiopaque Markers
- K191614 — BioSticker System
- K191667 — Electronic Stethoscope
- K191898 — Sterile Latex Powder-Free Surgical Gloves
- K192189 — Avenir Complete Hip System, Size 0 Coxa Vara
- K192580 — STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device
- K192584 — BEACON Caresystem Model 00002144
- K192670 — Neodent Instrument Kit Cases
- K192680 — Percusys® Plus Pedicle Screw System
- K190725 — Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White
- K191758 — Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit
- K192249 — InMode System with Tone Applicator
- K192267 — ILUMIEN System with AptiVue Software version D.3
- K192450 — Precision Casting Solutions Total Hip System
- K192572 — CNS Envision
- K192595 — ExSpiron 2Xi
- K192615 — Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)
- K192763 — syngo.CT CaScoring
- K193039 — Single Use Balloon Dilator V (with knife)
- K193071 — Bashir Plus Endovascular Catheter
- K193179 — EV1000 Clinical Platform
- K193219 — G Surgical Marksman System
- K181548 — Pantheon Spinal Pontus Interbody Fusion Device
- K190394 — SunClear Aligner system
- K190903 — Lawson Retrograde Nephrostomy Wire Puncture Set
- K191306 — Llis, Vittra APS
- K191751 — EM Provisional
- K191834 — Stand-Alone ALIF Titanium System
- K192539 — Deka Luxea
- K192744 — CORRIDOR Fixation System
- K192762 — Physio Flex Annuloplasty Ring
- K192943 — CEDIA Heroin Metabolite (6-AM) assay
- K193174 — Keos Lumbar IBFD
- K190833 — AXS Vecta Aspiration Catheter
- K192356 — Airlock Centrolock Osteosynthesis Implant System
- DEN190034 — Control-IQ Technology
- K182731 — Corelink Navigation Instruments
- K183424 — Ambar, Ambar APS, Ambar Universal APS
- K190715 — EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand
- K190717 — Infrared Thermometer, model: PC808
- K190738 — MyShoulder Placement Guides
- K190742 — EPIFLO-28
- K190752 — Satisfaite
- K191106 — C50 and C80 Multi-parameter Patient Monitor
- K191118 — Avanti Distal Radius and Forearm System
- K191796 — Neo Cage System
- K192130 — Icobrain
- K192152 — DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System
- K192220 — ReliOn Premier Classic Blood Glucose Monitoring System
- K192362 — Aero Blue Performance Surgical Gowns
- K192370 — MEDRAD Stellant FLEX CT Injection System with Certegra Workstation
- K192531 — QyScore Software
- K192554 — decimal3D
- K192569 — Diode Laser Therapy System
- K192627 — Laser Hair Growth Cap
- K192647 — neria guard Infusion Set
- K192829 — Demetra BDEM-01 Dermatoscope
- K193148 — VaPro Plus Pocket, VaPro Plus
- K193162 — EPi-Sense Guided Coagulation System with VisiTrax
- K193170 — Deep Learning Image Reconstruction
- K193173 — CareView 1800Le
- K193194 — CrossTorq 14 Guidewire
- K193202 — EXALT Model D Single-Use Duodenoscope, EXALT Controller
- K193317 — CoreLite X-Ray Specimen Cabinet
- K193344 — Tri-Ex Extraction Balloon with Multiple Sizing
- DEN180056 — GSP Neonatal Creatine Kinase - MM kit
Data sourced from openFDA. This site is unofficial and independent of the FDA.