FDA 510(k) clearances — page 301
clearances on record, most recent first.
Clearances — page 301
30,001–30,100 of 175,699- K162128 — Scope Buddy Plus Endoscope Flushing Aid
- K162251 — Reprocessed Viking Diagnostic Electrophysiology Catheters
- K162259 — DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
- K162421 — IntelliCartTM System
- K162436 — EndoVac Pure
- K162555 — EVS 4343, EVS 4343G
- K162677 — L- OVC
- K162717 — Evolution Esophageal Stent System Partially Covered
- K163086 — VLP MINI-MOD 2.0mm Column Plates
- K163264 — Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled
- K163266 — Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument
- K163311 — GMK Revision Femoral Distal Augmentation
- DEN150022 — Ultravision Visual Clearing System
- K160574 — K3PRO SURGICAL TRAY
- K160879 — CONFIDENCE High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems
- K160928 — Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green)
- K162344 — INNOLUX RIC
- K162461 — Endoform Plastics and Reconstructive Matrix
- K162630 — CP Relief Wand-OTC
- K163301 — CD HORIZON® Spinal System
- DEN150057 — Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5
- DEN160005 — Hem-Avert Perianal Stabilizer
- K160007 — Paclitaxel Sets
- K160515 — PS2 Knee System
- K160571 — cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay
- K160771 — Destiknee Total Knee System
- K160854 — MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture
- K161259 — KLS Martin Cannulated Headless Screws
- K161390 — Vinyl Exam Gloves, Powder Free, Clear
- K161739 — Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
- K161871 — EVA (Enhanced Visual Assessment) System
- K162081 — BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe
- K162854 — Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml
- K162955 — Multi-Modality Tumor Tracking (MMTT) application
- K160707 — CustomizedBone Service
- DEN150038 — CleanCisionTM Wound Retraction and Protection System
- K160614 — Xcite Clinical Station
- K160742 — NoCoding1 Plus Blood Glucose Monitoring System
- K161237 — HyperView Hyperspectral Tissue Oxygenation Measurement System
- K161713 — Dentium CAD/CAM Abutments
- K161837 — ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer
- K161947 — Chagas Detect Plus Rapid Test
- K162020 — VITROS Chemistry Products Cl- Slides
- K162161 — Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit
- K162302 — Somatom Confidence ® RT Pro
- K162373 — LC Bead LUMI
- K162578 — Zerona Z6 OTC
- K162638 — CETRA Anterior Cervical Plate System
- K163213 — Revolution CT
- K163236 — COOLIEF Cooled Radiofrequency Kit
- K143369 — MRidium 3860+ MRI infusion Pump/ Monitoring System
- K160798 — IPS e.max® Press Abutment Solutions for Viteo Base Ti
- K160836 — Menai System
- K160849 — WS(TM) Far-Infrared Therapy Unit, Model KP-B210
- K160852 — Zia
- K161060 — Arthrex iBalance UKA System Vitamin E Tibial Bearing
- K162192 — BluePro
- K162247 — PERMATAPE
- K162371 — Pulsaderm ACE-All Blue
- K162568 — INTRABEAM 600
- K162845 — DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System
- K162902 — ARIETTA Prologue Diagnostic Ultrasound system and Transducers
- K163206 — SMD-Sr90-DA Radionuclide Brachytherapy Source
- K163335 — 6MP Color LCD Monitor, RadiForce RX660, RX660-AR
- K163336 — xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR
- K163347 — xTAG Cystic Fibrosis 39 Kit v2
- K160225 — GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator
- K160402 — GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)
- K160412 — GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)
- K160415 — GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)
- K160475 — Ritter Dental Implant System
- K160915 — Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker
- K161233 — OXINIUM DH Fermoral Heads
- K161755 — Integrity-SI TM Fusion System
- K162051 — Cryotec
- K162134 — ENNOVATE Spinal System
- K162343 — Westmed Gas Sampling Cannula with O2 delivery
- K162680 — SOVEREIGN® Spinal System
- K162900 — PowerMidline Catheter
- K163163 — XLTEK EMU40EX EEG Headbox
- K163174 — Emerge PTCA Dilatation Catheter
- K163200 — Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete
- K160210 — EnSite Precision Cardiac Mapping System v2.0
- K160218 — AutoMark Module
- K160306 — Cloud Smart Thermometer
- K160335 — Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D
- K160941 — Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter
- K161844 — Matrix Pre-Treatment Controller
- K162010 — HPM-6000U
- K162643 — MediGuide Technology System
- K163203 — Carestream DRX-Evolution
- K160745 — neoBLUE compact LED Phototherapy System
- K160969 — ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler
- K162114 — Photon, Photon Plus
- K162327 — COUGAR® LS Lateral Cage System and COUGAR® System
- K162420 — Sysmex Automated Blood Coagulation Analyzer CS-5100
- K162442 — ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500
- K162476 — Varian High Energy Linear Accelerator
- K162648 — U-Blade Veress Needle
- K163063 — UC-5000 Mobile X-Ray
Data sourced from openFDA. This site is unofficial and independent of the FDA.