FDA 510(k) clearances — page 242
clearances on record, most recent first.
Clearances — page 242
24,101–24,200 of 176,542- K182250 — Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm), , Solero microwave Tissue Ablation Applicator (19cm), Solero microwave Tissue Ablation Applicator (29cm)
- K182629 — Digital Thermometer
- K182839 — Lifetech Cardio Model 8301 Temporary Pacemaker
- K183099 — QUANTIEN Measurement System
- K183313 — EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)
- K183686 — FUJIFILM Endoscope Model EG-530N
- K180682 — AeroPro Cordless Prophy System
- K182003 — Lympha Press Optimal Plus
- K182267 — PAT (Pain Alleviation Technologies)
- K182494 — FlowMet-R
- K183014 — uPMR 790
- K183683 — FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5
- K190087 — EzDent-i / E2 / Prora View
- K190155 — FibermarX Radiopaque Tissue Marker
- K181870 — Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use
- K182052 — Omni Instrument Tray
- K182440 — Body System
- K182941 — HEALIX ADVANCE SP PEEK Anchor
- K183211 — 3M Comply Hydrogen Peroxide Chemical Indicator
- K183360 — VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 >=64/8 µg/mL)
- K183374 — GrayDuck Stent
- K183454 — Tyece OTC EMS System
- K190356 — ClariFix
- K182976 — SpringTMS
- K183179 — CAPERE Thrombectomy System
- K183290 — Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200
- K183698 — Zap-X Radiosurgery System
- K190071 — Perla® Posterior Cervico-Thoracic Fixation System
- K190151 — COBRA Fusion Ablation System
- K181310 — HeartCheck Cardi Beat ECG Monitor with GEMS Mobile
- K181551 — DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette
- K182406 — Altus Spine Interbody Fusion System
- K182488 — Reprocessed Response Diagnostic Electrophysiology Catheter
- K182542 — The EPAD 2 System
- K182643 — IRIS 1.0 System
- K182825 — FUJIFILM Ultrasonic Endoscope
- K182859 — Babyleo TN500
- K183240 — Empower RF Catheter
- K183365 — Libertas Acetabular Hooded Liner
- K183588 — Choice Spine Hawkeye Vertebral Body Replacement (VBR) System
- K183621 — EMMA 1.5T MRI System
- K183640 — Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes
- K183693 — Doctor Tecar
- K173418 — NobelParallel Conical Connection
- K182578 — Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device
- K182641 — Sensus IORT System
- K182665 — Sensus TPS Workstation
- K183255 — Coag-Sense Prothrombin Time (PT) / INR Monitoring Device
- K183279 — HEALIX Ti ANCHOR with DYNACORD
- K190105 — ZOOM Aspiration Pump
- K190255 — Sensus Healthcare TVM Balloon Applicator
- K180953 — AnyCheck IMT-100
- K181989 — MRIdian Linac System
- K183415 — VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL)
- K180346 — Byte Aligner System
- K181409 — Pressure Therapy System PT1003
- K181872 — MIS Bunion System
- K183055 — Vector Hammertoe Correction System
- K183241 — BrainScope TBI (Model: Ahead 400)
- K183594 — Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm +6 more
- K182768 — TMS-Cobot TS MV
- K180509 — Quo-Test A1c System
- K181163 — Wu's Powered Wheelchair
- K181362 — TEMA Elbow System
- K183546 — GEM Premier ChemSTAT
- K183549 — GEM Premier ChemSTAT
- K183555 — GEM Premier ChemSTAT
- K183704 — RX-1 Rhythm Express Remote Cardiac Monitoring System
- K173937 — SpiroSphere
- K181194 — SmartMouth DryMouth Oral Rinse
- K181353 — Lunderquist® Fixed Core Wire Guide
- K181393 — Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP
- K181507 — PREVENA RESTOR(TM) Incision Management System
- K181534 — CIRRUS HD-OCT
- K182293 — OsseOne Dental Implant System
- K182332 — PhantomMSK
- K182932 — RS85 Diagnostic Ultrasound System
- K183039 — ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
- K183049 — Reliance Lumbar IBF System
- K183072 — EndoFLIP System
- K183209 — 3M Comply Hydrogen Peroxide Indicator Tape
- K183217 — IPL Hair Removal Device
- K183222 — MAGNETOM Terra
- K183225 — Stabil Orthopaedic Solutions Total Knee System
- K183324 — Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mL
- K183556 — oCare Wrist Pulse Oximeter
- K190138 — MAGNETOM Aera
- DEN180058 — t:slim X2 insulin pump with interoperable technology
- K181315 — Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing
- K181930 — GMC Wrist Automatic Blood Pressure Monitor
- K182188 — Ion Endoluminal System; Flexision Biopsy Needle
- K182677 — DynaNail Mini
- K182705 — Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups
- K182756 — MyoStrain 5.1
- K183063 — Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems
- K183083 — Shoreline Cervical Interbody RT System
- K183196 — Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker
- K183206 — Dexcom G6 Continuous Glucose Monitoring System
- K183221 — MAGNETOM Amira, MAGNETOM Sempra
- K183317 — AdvantageRib System
Data sourced from openFDA. This site is unofficial and independent of the FDA.