FDA 510(k) clearances — page 243
clearances on record, most recent first.
Clearances — page 243
24,201–24,300 of 176,542- K183506 — HEALIX ADVANCE Anchor with DYNACORD Suture
- K183569 — DD cube ONE ML
- K183635 — PhotoFix Decellularized Bovine Pericardium
- K190074 — Presero 3D Scanning System
- K181508 — U&U Blood Collection Sets
- K181661 — QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System
- K182661 — Kava and Kava with Herbst
- K182874 — Fenom Pro Nitric Oxide Test
- K182915 — ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube
- K182974 — NuVasive Reline System
- K182991 — EPIC Extremity Fusion Plate System
- K183161 — SnapShot Freeze 2
- K181955 — WiEMSpro
- K182934 — FORA P100 Blood Pressure Monitoring System
- K183127 — MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL)
- K183167 — Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens +3 more
- K183375 — Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode
- K183637 — Cruxcan (CRX-1000)
- K190056 — KOWA VK-2s
- K190075 — Aurora Evacuator
- K180691 — TrueDorsal Devices
- K181340 — Cemented TSI Hip Stem
- K183073 — SMG Anterior Cervical Plate System
- K183166 — BacT/ALERT FA Plus; BacT/ALERT PF Plus
- K183396 — HANAROSTENT FASTTM Biliary (NNN)
- K183409 — Athena II Cervical Plate System
- K183477 — easyPPHTM Hemorrhoidal Stapler for Single Use
- K183557 — Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device
- K183585 — Elitone Device
- K190078 — IntraSight
- K190085 — Journey II Unicompartmental Knee System
- K180835 — SEKURE Acetaminophen L3K Assay
- K181143 — Keeler TonoCare Tonometer
- K181317 — Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
- K181467 — Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line
- K182040 — Coala Heart Monitor
- K182833 — ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer
- K183141 — LINK MP Monoblock Hip Prosthesis
- K183186 — Head Coil 12, Head Coil 32, Carotid Coil 8, Temporomandibular Joint Coil 4, Infant Coil 24, Cardiac Coil 24, Foot & Ankle Coil - 24
- K183245 — Carestream DRX-1 System with DRX Plus 2530 Detectors
- K183517 — Ammonia II
- K181577 — AcQMap High Resolution Imaging and Mapping System
- K182224 — SafeAir Smoke Evacuator compact
- K182259 — Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal
- K182417 — ROSA ONE Brain Application
- K183118 — dpl SpotLite
- K183134 — ArcTV Transvaginal Sling System
- K183235 — SonoSite SII Ultrasound System
- K183331 — Parcus GFS BTB
- K190035 — Biomet Headless Compression and Twist-Off Screws
- K181981 — CO2 Sampling Line
- K182102 — RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4
- K182796 — WavelinQ 4F EndoAVF System
- K182885 — Atlantis Anterior Cervical Plate, Divergence Anterior Cervical Fusion System, Premier Anterior Cervical Plate, Venture Anterior Cervical Plate, Zephir Anterior Cervical Plate System and Zevo Anterior Cervical Plate System
- K183119 — SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments
- K183435 — Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black
- K183659 — Omnia Medical Rotary PLIF System
- K190045 — DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives
- K181142 — Absoanchor Microimplant
- K182170 — PRECICE® BONE TRANSPORT System
- K183081 — Spectra Optia Apheresis System
- K183132 — Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
- K183163 — Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix
- K183388 — JADE Mobile X-Ray
- K183498 — JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD Monitor
- K181916 — d-Nav System
- K183447 — EIT Cellular Titanium Lumbar Cage - T/PLIF
- K183499 — JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor
- K183571 — Capture-CMV
- K190067 — Velofix Interbody Fusion System
- K180626 — Pedimax II - Pedicular Screw Spinal System
- K181070 — iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)
- K181657 — easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use
- K181751 — HemoCue Hb 801 System
- K182094 — Family of Venus RF Systems - Heal
- K182191 — Invia Abdominal Dressing Kit
- K182319 — Glo-Tip Spray Catheter
- K182744 — HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High
- K183139 — Endoscope Sterilization Tray
- K183272 — AI Rad Companion (Engine)
- K183275 — DR 800 with Tomosynthesis
- K183291 — Supria True64 Whole-Body X-Ray CT System
- K183452 — Vbeam Prima Laser System
- K190053 — SECULOK ACP System
- K181129 — STRONG Dental Handpieces
- K182198 — Panoura X-ERA PF/NF/MF
- K182827 — SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900
- K183020 — Endosee System
- K182327 — Patient Cables and Leadwires , Disposable ECG Leadwires
- K182986 — Boston Keratoprosthesis, Type I Lucia
- K183029 — MOTO Partial Knee System
- K183136 — Zimmer Segmental System Proximal Femoral Component
- K183696 — Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid
- K181048 — Neo Cage System TM
- K181580 — Cortex CAD/CAM Abutments
- K181893 — T-PLUS
- K182000 — AQrate Robotic Assistance System
- K182521 — FastPack IP Sex Hormone Binding Globulin Immunoassay
- K182648 — X5 Series Digital Color Doppler Ultrasound System
- K183022 — Solitaire 4 Revascularization Device
Data sourced from openFDA. This site is unofficial and independent of the FDA.