FDA 510(k) clearances — page 262
clearances on record, most recent first.
Clearances — page 262
26,101–26,200 of 175,699- K173873 — BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial
- K180129 — Imbio Segmentation Editing Tool software
- K180172 — FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG
- K180195 — Frigitronics adapter
- K180404 — 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System
- K180411 — MEMO 4D
- K180426 — Empower H35
- K171430 — Incontinence Treatment Device, Model LT2061
- K171808 — TDM Plate and Screw System
- K173180 — Mega Plus Spine System
- K173811 — TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System
- K173839 — Tissue of Origin Test Kit-FFPE
- K180153 — X-spine Cortical Bone Screw System
- K180198 — NuVasive® VuePoint® II OCT System
- K180224 — ELEMENT-TL
- K180227 — Polaris Spinal Growth System
- K180330 — Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL
- K180393 — AIRO Computed Tomography (CT) X-ray System
- K180396 — miraDry System
- K180405 — FUJIFILM Endoscope Models EC-600HL and EC-600LS
- K180406 — Ellipse Ydun
- K180423 — Empower H65
- K180448 — INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter
- K171778 — MR Wireless Gating System, Model WGS-100
- K172012 — star RF Electrode, VIVA RF Electrode
- K172266 — Dynarex Three-Way Stopcock
- K172431 — Cardiovascular Analzyer
- K172795 — Infrared Thermometer
- K173203 — Athena GTX Device Management Suite (ADMS) Software
- K173794 — AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared
- K173798 — Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
- K173980 — Specular Microscope CEM-530
- K180104 — Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant
- K180421 — Natus NeuroWorks
- K180429 — Advincula Delineator Uterine Manipulator
- K171817 — Biodesign Diaphragmatic Hernia Graft
- K173459 — Olympus Small Intestinal Capsule Endoscope System
- K173694 — STERIZONE VP4 Sterilizer
- K173785 — Custom Clear Aligner System
- K173792 — EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay
- K180106 — ThinkQA
- K180374 — Voluson S8/ Voluson S10/ Voluson S10 Expert
- K173229 — Preview Digital Pregnancy Test
- K173583 — Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners
- K173734 — RocaJJ Soft Stents
- K173779 — REXMONO, PDREX
- K180262 — SICAT Endo
- K180450 — Corvocet Biopsy System
- K173628 — Acclarent ENT Navigation System
- K162616 — Wrist Type Blood Pressure Monitor
- K171764 — Fixed Core Wire Guides
- K171820 — Transjugular Liver Access Sets
- K172057 — Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set
- K172799 — Positional Sleep Assessment System (PoSAS) software
- K173078 — Powder-free Clear Vinyl Patient Examination Gloves
- K173388 — Exactech Equinoxe Stemless Shoulder
- K173426 — PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System
- K173481 — Amsco Evolution Medium Steam Sterilizer
- K173682 — L300 Go System
- K173690 — Grass TWin
- K173796 — Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references)
- K173812 — Catalyst CSR 3 Peg Glenoids
- K173904 — CATS Tonometer Prism
- K173939 — Quantib Brain
- K180057 — VORTEK URETERAL DOUBLE LOOP STENT
- K180061 — UltraCor Twirl Breast Tissue Marker
- K180159 — Klassic® Knee System
- K180394 — BrightMatter Plan 1.6.0
- K171150 — AW-100
- K171320 — ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION Screws
- K172115 — Navigated Instrument System
- K172892 — Neuro Assessment System NAS-1000
- K173075 — ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)
- K173249 — CD HORIZON Spinal System
- K173323 — AnastoClip GC Closure System
- K173440 — Carriere SLX 3D Clear
- K173500 — NMF004A
- K173605 — iQMR
- K173625 — syngo.CT Clinical Extensions
- K173713 — HS70A Diagnostic Ultrasound System
- K173769 — DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid
- K173772 — BreathID Hp System
- K173777 — BreathID Hp Lab System
- K180044 — SIROLaser Blue
- K180086 — Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter
- K180092 — Intellitorq
- K180105 — Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister
- K180135 — THD Anopress with THD SensyProbe
- K180171 — PillCam Patency System
- K180326 — icobrain
- K180335 — Accutension Smartphone Auscultatory Blood
- K171802 — ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
- K171810 — Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter
- K171939 — ALVUE Balloon Dilation System
- K172758 — Rotatable Snares, Non-Rotatable Snares
- K172810 — PORT-X IV
- K172818 — LMT-3000
- K173114 — primeMidline Catheters
- K180156 — SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System
- K180196 — On Call Express Mobile Blood Glucose Monitoring System
Data sourced from openFDA. This site is unofficial and independent of the FDA.