FDA 510(k) clearances — page 194
clearances on record, most recent first.
Clearances — page 194
19,301–19,400 of 175,699- K200248 — Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators
- K200561 — StimPlus Patch, StimPlus Patch, StimPlus Patch
- K200880 — T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2 Greater Trochanter Nail (GTN),T2 Ankle Arthrodesis Nail,T2 Arthrodesis Nail System
- K201449 — SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring
- K201477 — syngo.via View&GO
- K191276 — Dental Electrical Motor iRoot Pro
- K192778 — Kinos Axiom Total Ankle System
- K193632 — LassoStar Circular Mapping Catheter
- K200265 — Surgical Drills
- K200272 — Terragene Chemdye
- K200874 — TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End
- K201455 — Litho 150, Cyber Ho 150
- K201464 — Altapore MIS
- K192900 — H500 Multi-Sensing Oximetry System
- K193119 — Twin-Pass Dual Access Catheter
- K200068 — Arthrex DynaNite K-Wire
- K200354 — Electronic stimulator
- K200420 — Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green
- K200698 — Somnera System
- K201156 — ARTIS pheno (VE2)
- K201423 — MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)
- K201503 — Edge Air(1417) Digital Flat Panel X-ray Detector
- K201507 — Cadence Total Ankle System
- K200888 — OMNIBotics Knee System
- K182081 — JDentalCare Implant System JDIcon
- K191443 — MSDI Dental Implants System
- K193042 — Optimized Positioning System (OPS) ReView
- K193473 — LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US
- K193525 — Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M
- K193600 — EndoGI Biliary Stent System
- K200095 — Streamline Navigated Instruments
- K200226 — RetroFix
- K200250 — Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor
- K200720 — D-Stat Radial Topical Hemostat
- K200723 — StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)
- K200736 — Stardust Med
- K200760 — Rapid ASPECTS
- K200825 — NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense
- K200840 — DuoHex CH Cannulated Hammertoe System
- K201119 — ChartCheck
- K201146 — Ion Endoluminal System
- K201148 — EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License
- K201164 — Venus Viva MD Device
- K201181 — EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System
- K201373 — DRX-Compass
- K192028 — Yumizen C1200 CRP
- K192221 — Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts
- K193348 — Blood Pressure Monitor
- K200175 — DIA-ROOT BIO Sealer
- K200295 — IlluminOss Bone Stabilization System
- K200437 — Blood Pressure Monitor
- K200582 — Bendit2.7 Steerable Microcatheter
- K200614 — FiteBac Antimicrobial Cavity Cleanser
- K200815 — VitriGuard
- K200834 — Lever Action Plate System
- K201414 — Rotium Bioresorbable Wick
- K192710 — The Simple Locking Intramedullary (Slim) System
- K193477 — Nd: YAG Laser Therapy Systems
- K200445 — The C100 Contactless Breathing Monitor
- K200495 — Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve
- K200663 — ControlRad Trace Model 9
- K200855 — CINA
- K200975 — Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum
- K201462 — ACUSON Sequoia Diagnostic Ultrasound System
- K200232 — LVivo Software Application
- K200617 — Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525
- K200772 — ULab Systems uDesign Software
- K200774 — CUSA Clarity Ultrasonic Surgical Aspirator System
- K201096 — CO2mbiLED
- K201668 — VarseoSmile Crown plus
- K192337 — Zeroveno
- K192404 — Patient Monitoring Cable (SpO2 Extension Cable)
- K192466 — Air Compression Therapy System
- K192549 — Byteflies Kit
- K200195 — NES Reprocessed Visions PV .014P RX Digital IVUS Catheter
- K200627 — GlidePath 10F Long-Term Dialysis Catheter
- K201107 — Opera Lebody (Gold), Opera Lebody (Zafiro)
- K201140 — Axeos
- K201151 — O-Mec 690 Series Laparoscopes
- K191923 — EverLift Submucosal Lifting Agent
- K201430 — InFrame Cannulated Fixation System
- K190637 — Fit & Brilliant Dental Implant System
- K191913 — TruAbutment DS
- K192024 — Cemented TSI Hip Stem
- K192910 — STATClave G4 Chamber Autoclave
- K192954 — Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl
- K192963 — Kogent Torus Ultrasonic Aspirator
- K193106 — SpineFrontier Lumbar Interbody Fusion Device System
- K193298 — BriefCase
- K200438 — MPS 3 Myocardial Protection System
- K200471 — Infrared Thermometer Model Number RN-60A,RN-60B
- K200574 — EksoNR
- K200671 — Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for
- K201339 — The NOxBOXi Nitric Oxide Delivery System
- K201340 — AQUILA 320 D / AQUILA 320 S
- K201370 — Multiflex Tinnitus Technology
- K192274 — BV Dental Implant System
- K192604 — Servo-air 4.0 Ventilator System
- K193234 — NUVO IF Implant System
- K193513 — SIGNAFUSE Bioactive Bone Graft
Data sourced from openFDA. This site is unofficial and independent of the FDA.