FDA 510(k) clearances — page 270
clearances on record, most recent first.
Clearances — page 270
26,901–27,000 of 176,542- K173887 — cobas CT/NG for use on cobas 6800/8800 systems
- K180023 — WIRION
- K180148 — ATS Thermal Imaging Probe, ATS Patient Interface Unit
- K180192 — Emprint Ablation Visualization Application
- K180211 — Freezpoint
- K180274 — Ventix Link Knotless Anchor with Inserter
- K170957 — ReConnex Pre-Sutured Tendon
- K171989 — Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal Catheter
- K172762 — Single Use Hemoclip
- K173451 — Ingenia Elition S and Ingenia Elition X
- K173919 — HX Device
- K180015 — Philips Incisive CT
- K180016 — Home Use IPL Beauty Device
- K180165 — Habib EndoHPB
- K180438 — BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
- DEN170029 — PrimeStore MTM
- K171863 — Anjon Bremer Halo System
- K171912 — Double Flexible Tip Wire Guides
- K172148 — Anchorage Bone Plating System
- K172264 — OTW Takeru PTCA Balloon Dilatation Catheter
- K173237 — Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist
- K173437 — 3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H
- K173499 — Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads
- K173740 — Reprocessed DePuy Mitek Ablation Wand
- K173930 — PYTHON Plate Trial Instruments
- K180475 — CapLOX II® / TowerLOX® MIS Pedicle Screw System
- K180579 — Ezee Retrieval
- K173841 — AXS Catalyst Distal Access Catheter 058 x 115cm +2 more
- DEN160044 — Acumen Hypotension Prediction Index (HPI) Feature Software
- K171542 — TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges
- K171851 — SOFTXIL
- K171937 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor
- K172366 — Wrist Pulse Oximeter
- K172516 — SurgiQuest AIRSEAL iFS System
- K172593 — XCelliStem Wound Powder
- K172928 — Portable X-ray System
- K173120 — CCM Abutment System
- K173181 — ExSpiron 1Xi
- K173326 — MIS CONNECT Conical Connection Abutment
- K173358 — ARTAS System
- K173611 — syngo Application Software
- K173752 — SI Screw System
- K173840 — Xpert CT/NG
- 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 +3 more
- 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 +3 more
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.