FDA 510(k) clearances — page 211
clearances on record, most recent first.
Clearances — page 211
21,001–21,100 of 176,479- K193481 — AeroNOx 2.0 Nitric Oxide Titration & Monitoring System
- K200041 — FlexPointer 1.5 Single Use, FlexTube 3 Single Use
- K200331 — Rapid Acoustic Pulse Device
- K200370 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit
- K183570 — LiquiBand Plus
- K191624 — F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version
- K192574 — Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
- K192815 — Elecsys BRAHMS PCT
- K193216 — syngo.CT Lung CAD
- K193262 — DR 600 with Tomosynthesis
- K193425 — Pre-Milled Blank
- K193426 — Elite iQ
- K200048 — MectaLIF Anterior Simple
- K200049 — Senhance Surgical System
- K200258 — Edwards eSheath Introducer Set
- K190652 — OSSIOfiber Hammertoe Fixation System/OSSIOfiber Hammertoe Fixation Implant
- K190918 — SwabTip Male Disinfectant Cap
- K191031 — NightOwl
- K191562 — Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor
- K191566 — Avinent Surgical Tray
- K191568 — sam 2.0 Long Duration Ultrasound System
- K191583 — PhotonBlade with Smoke Evacuation
- K191655 — MEGAFIX® Pedicle Screw Spinal System
- K191915 — SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe V
- K192164 — Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR
- K192813 — Plasma IQ
- K193393 — BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format).
- K200267 — LOSPA® IS Spinal Fixation System
- K200304 — EPIQ Diagnostic Ultrasound System
- K200306 — CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit
- K200310 — 1688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with Advanced Imaging Modality
- K200311 — VersaWrap Tendon Protector
- K200396 — Insight Enhanced DRF Digital Imaging System
- K190527 — GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters
- K190993 — Kinepict Medical Imaging Tool version v2.2
- K191184 — ImmuView S pneumoniae and L pneumophila Urinary Antigen Test
- K191709 — V-STRUT Vertebral Implant
- K191991 — Ezfil
- K192590 — CURA 778
- K192697 — Instinct Plus Endoscopic Clipping Device
- K193072 — Lucent : IPL
- K193101 — Omnifix Low Dead Space Luer Lock Syringe
- K193139 — ProVecta 3D Prime Ceph
- K193147 — Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System
- K193229 — Transpara
- K193402 — ALLthread PEEK Suture Anchor
- K193529 — ATLANTIS Abutment for MIS Conical Connection Implants
- K200360 — TrackX
- K190509 — Lubrina 2
- K191525 — KinematX Total Wrist Arthroplasty System
- K191550 — Broncholab
- K192906 — Mecta-C Stand Alone
- K193019 — DANNIK Disposable Monopolar Laparoscopic Instrument
- K193374 — TumEase Acupressure Bracelets
- K193389 — Vista Clear
- K193616 — ARIX Ankle System
- K200028 — Coronet Soft Tissue Fixation System
- K200262 — L100 Go System
- K200269 — Sapphire II PRO
- K200314 — Capere Thrombectomy System
- K192032 — Fixone Biocomposite Small Anchor
- K193064 — Atlantis suprastructures
- K193358 — MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL)
- K200275 — OVision Imaging System
- K183425 — CARDIOVIT AT-102 G2
- K191872 — Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution
- K192506 — Vantage Galan 3T, MRT-3020, V6.0
- K192637 — High Strength Suture
- K193256 — Anjon Bremer Halo System
- K193356 — BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
- K193378 — CarboClear Lumbar Cage System
- K193532 — LIAISON Anti-HAV Assay
- K190304 — Kingon P2 Oxygen Concentrator
- K183680 — i-STAT CHEM8+ cartridge with the i-STAT 1 System
- K191246 — Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)
- K191555 — HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length
- K191556 — Red Dot
- K191928 — AccuContour
- K192247 — Steripath Gen2 Blood Collection System
- K192346 — scaffolene CL100 Bioresorbable Collagen Matrix
- K192447 — Superelastic Staple
- K192496 — Magnetom Sola, Magnetom Altea and Magnetom Sola Fit
- K192570 — Atlas Spine Expandable Cervical Standalone Interbody System
- K192660 — Zimmer M/L Taper Hip Prosthesis
- K192820 — SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs)
- K192962 — icobrain-ctp
- K193029 — CONQUEST FN
- K193243 — Alta Multipurpose Device
- K193416 — Cellvizio I.V.E. with Confocal Miniprobes
- K193483 — Basal-IQ Technology
- K193550 — Therm-X
- K200221 — CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor
- K200225 — Arctic Sun Stat Temperature Management System
- K200284 — R-Sensor, R-Sensor
- K200381 — Daytona® Small Stature Spinal System
- K190032 — Disposable Sclerotherapy Needle
- K190682 — Explorer Mini
- K190919 — ST Internal Implant System
- K191462 — Proov Test
- K191946 — Penumbra System Penumbra JET 7X
Data sourced from openFDA. This site is unofficial and independent of the FDA.