FDA 510(k) clearances — page 214
clearances on record, most recent first.
Clearances — page 214
21,301–21,400 of 175,699- K192504 — Treace Medical Concepts (TMC) Plating System
- K192775 — Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri
- K192783 — Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile
- K192790 — Atellica IM Total hCG (ThCG)
- K191385 — BRILLIANT COMPONEER
- K191855 — EmFace Device
- K191862 — Compression Therapy Device Model LGT-2200SP
- K191925 — MATRx Plus
- K192041 — G21 SpaceFlex Hip
- K192053 — W Zirconia Implants
- K192114 — Game Ready GRPro 2.1 System
- K192121 — Black Diamond Pedicle Screw System
- K192133 — Zimmer Biomet Universal Navigation System
- K192173 — ROSA ONE Spine application
- K192369 — PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
- K192494 — NexGen Anterior Cervical Plate System
- K180347 — 3d Cage
- K182605 — HS AMICA devices family
- K191881 — KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun
- K192029 — Straumann PUREloc abutments
- K192046 — LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set
- K192673 — 3M Comply Hydrogen Peroxide Indicator Tape 1228
- K192802 — primeMidline Catheters
- K190624 — EarlyVue VS30
- K190181 — Instruments for LINK MEGASYSTEM-C Family
- K190221 — IOB Warming Blankets
- K190847 — REDAPT Blade Augments
- K191007 — Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems
- K191085 — Maverick RNP Assay and Maverick Diagnostic System
- K191470 — C-CAT Anaesthesia Catheter kit
- K191563 — FILTRAY 2G Disposable Water Filters
- K191807 — ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device
- K191874 — F5 Corpus VS
- K192360 — IntellaMap Orion High Resolution Mapping Catheter
- K192518 — Reusable Monopolar Active Cord
- K192667 — gel-e Flex+ gel OTC
- K192705 — MiniCap Extended Life PD Transfer Sets
- K192725 — Cytal Wound Matrix 3-Layer
- K192787 — Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System
- K181660 — Acapella Choice Blue Vibratory PEP Device
- K190037 — Cronus HP PTA Balloon Catheter
- K190210 — Tear Pool Dissolvable Punctum Plugs
- K190349 — MediExpand TL Expandable VBR System
- K190426 — ALTA Anterior Cervical Corpectomy System
- K190556 — Zimmer Biomet Universal Navigation System
- K190632 — Latex Surgeons Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein
- K191358 — Trident II Acetabular System
- K191812 — ADI Cervical Interbody Fusion Device
- K191944 — MU2net
- K192678 — Genesys Spine Binary® Lumbar Plate System
- K192686 — Revolution Maxima, Revolution Ace
- K192690 — Upgrade Kit MR GUI PRO, MrJ 3300 Plus
- K192722 — Padlock Clip defect closure system, Padlock Pro-Select defect closure device
- K192728 — Agnes
- K182743 — Patient-Specific Airway Stent
- K183562 — Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs
- K190157 — Diana ChemoClave Transfer Set
- K191258 — Intraosseous infusion device
- K191814 — Alliance Glenoid
- K192314 — RESONATE Anterior Cervical Plate System
- K183309 — stentfix OTSC System Set
- K183661 — ClearEdge Balance System
- K190539 — TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile
- K190890 — Exactech Alteon Modular Dual Mobility (MDM) System
- K191073 — Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter
- K191373 — VICRYL Mesh
- K191584 — FORTICO Anterior Cervical Fixation System
- K191973 — Lumpipulse G CA19-9-N
- K191979 — DORO QR3 XTom Headholder System
- K192001 — Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device
- K192084 — Madison Total Knee System
- K192268 — Europa Pedicle Screw System
- K192623 — LipiFlow Thermal Pulsation System
- K192737 — RCT800
- K192835 — ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound System
- K182862 — Servo Guard
- K190054 — BD Insulin Syringe
- K190136 — Fusion Silastic System
- K190270 — FORE-SIGHT ELITE Tissue Oximeter Module
- K191957 — BD MAX Vaginal Panel
- K191999 — Sterilucent VH2O2 Chemical Indicators
- K192280 — PENTAX Medical ED-3490TK Video Duodenoscope
- K192616 — CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ)
- K192659 — Omnipod Insulin Management System, Omnipod DASH Insulin Management System
- K190124 — EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One
- K190636 — NuVasive® Reline® 4.5-5.0 System
- K191513 — Altapore Shape
- K192532 — Arthrex SwiveLock Anchor
- K181896 — LIPOcel
- K183226 — Care Orchestrator Essence
- K183274 — RTHawk, HeartVista Cardiac Package
- K183625 — SomnaPatch
- K190342 — BIAFINE Topical Cream
- K190465 — Evolve Breast Pump
- K190646 — QT Scanner 2000 Model A
- K190795 — Tetragraph Neuromuscular Transmission Monitor
- K191283 — Infrared Thermometer, Breeze model
- K191430 — Pulse Oximeter
- K191436 — Saalio
- K191544 — Synapse 3D Blood Flow Analysis
Data sourced from openFDA. This site is unofficial and independent of the FDA.