FDA 510(k) clearances — page 345
clearances on record, most recent first.
Clearances — page 345
34,401–34,500 of 176,542- K152308 — Sensor Medical Single Use Tonometer Prism
- K152516 — BD BBL Sensi-Disc Ceftazidime Avibactam (30/20ug), Antimicrobial Susceptibility Test Disks
- K143577 — XW-100 Automated Hematology Analyzer, XW QC CHECK
- K150306 — D2RS_AT Digital Dynamic Remote System
- K151919 — Vitrea CT Lung Density Analysis Software
- DEN150011 — Sonablate 450
- K143499 — eCligner
- K150502 — DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls
- K151044 — CLICKLINE Scissor Insert for Single Use
- K151242 — SterilContainer S
- K151525 — Amia Automated PD System with Sharesource
- K151528 — Powder Free Nitrile (Black) Examination Gloves
- K151541 — G-Fix
- K151596 — Endoskeleton TCS Interbody Fusion Device
- K151693 — Dr-Ho's Foot Pad Electrode
- K151719 — REVE134
- K151746 — Dyevert Contrast Modulation System
- K151833 — Aquilion Lightning (TSX-035A/2, V7.0)
- K152036 — SOMATOM Definition Edge, SOMATOM Definition AS/AS+
- K152565 — Auto Suture Locking Trocar
- DEN150013 — FilmArray Meningitis/Encephalitis(ME) Panel
- K134036 — WAVETRONIC 5000 DIGITAL HF SURGICAL UNIT
- K150142 — Single Use Balloon Dilator V (with Knife)
- K150222 — X-Guide Surgical Navigation System
- K150557 — Podimetrics Remote Temperature Monitoring System
- K150669 — Neoss TiBase, Neoss CoCr Abutments (Mono and Multi)
- K150711 — Salem Sump Dual Lumen Stomach Tube with Multi-functional Port
- K151169 — OsteoReady ZircoSeal Abutments
- K151352 — CONCORDE Bullet Spinal System
- K151490 — PRETTAU ANTERIOR T0
- K151584 — AttraX Putty
- K151744 — Passeo-18 Peripheral Dilation Catheter
- K151921 — STERISPINE PS
- K152240 — Passeo-14 Peripheral Dilatation Catheter
- K152550 — MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM
- K152577 — ULTRASOUND SYSTEM SONIMAGE HS 1
- K152591 — Medilas H RFID Laser Fibers
- K151261 — Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit Large
- K151375 — Inclusive Titanium Abutments compatible with: Hiossen HG Implant System
- K151873 — Etest Ceftaroline (0.002 - 32ug/ml)
- K151941 — DEXIS Webview
- K150209 — Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor with Orthocord, PanaLok RC QuickAnchor Plus +2 more
- K150554 — NuBrilliance Light Pain Therapy
- K151266 — Physica CR Knee System
- K151360 — Inion Spinal Graft Containment System
- K151603 — Arcos One-piece Femoral Revision System
- K151610 — Comet Pressure Guidewire
- K151613 — iLab Polaris Multi-Modality Guidance System
- K151906 — ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD)
- K151917 — ARIES System
- K152369 — ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System
- K152572 — AXIOS Stent and Delivery System
- K143494 — ADX6000 Portable X-Ray System; iRayA6
- K143560 — CygneX I System
- K151500 — Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)
- K151747 — STERISPINE PS
- K151841 — Ultraviolet Sunlamps
- K151910 — Ultrasound Scanner System BK2300
- K152025 — AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)
- K141656 — GMATE MINI BLOOD GLUCOSE MONITORING SYSTEM, GMATE STEP BLOOD GLUCOSE MONITORING SYSTEM
- K143518 — Valeo Spacer System and Valeo II Interbody Fusion Device System
- K143655 — SICAT OPTIMOTION
- K150063 — One Step hCG Pregnancy Test
- K150754 — ARGOS
- K150892 — CorPath 200 System
- K151027 — zensor system
- K151408 — LOSPA IS Spinal System
- K151501 — OrthoVis Web Portal
- K151599 — iSy Implant System
- K151615 — TiTHON Staple with OsseoTi Technology
- K151949 — Disposable Insulin Syringe
- K152207 — Extended Range Shifter for PROBEAT-V
- K152526 — Elecsys Progesterone III CalSet
- K152545 — DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound Systems
- K142887 — SIS Inguinal Hernia Repair Graft
- K143515 — Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants
- K150031 — hemoFISH Masterpanel
- K150221 — EPX-4440HD and EPX-4400HD with FICE
- K150694 — 3M Comply Hydrogen Peroxide Indicator Tape 1228
- K151011 — VISERA 4K UHD SYSTEM
- K151952 — Synergy ODM
- K152177 — SonoStik IV Guide Wire Introducer
- K152523 — JBAIDS Influenza A & B Detection Kit
- K140827 — SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set
- K142928 — FreeStyle Precision Neo Blood Glucose Monitoring System
- K143245 — GPC Intramedullary Nailing Systems
- K150078 — PowerDot(R) PD-01 Muscle Stimulator (with PowerDot(R) Mobile Application)
- K150565 — Supria Whole-body X-ray CT System
- K151079 — Q2 Intravenous Adminstration Sets and Extension Sets
- K151149 — Ready-Fit
- K151280 — MultiScan G-Arm System
- K151849 — Seneka I Polyscrew Pedicle Fixation System
- K152524 — Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set
- DEN150002 — EarLens Contact Hearing Device
- K150622 — 3M Comply Hydrogen Peroxide Chemical Indicator 1248
- K150654 — Cholesterol
- K150998 — HEARTWAY Power Mobility Scooter
- K151100 — U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System
- K151576 — Neon EEG
- K151579 — MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit
Data sourced from openFDA. This site is unofficial and independent of the FDA.