FDA 510(k) clearances — page 235
clearances on record, most recent first.
Clearances — page 235
23,401–23,500 of 175,699- 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
- K183070 — ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010
- K173743 — Greenmedi Safety Filter Syringe
- K180822 — VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System
- K181307 — Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow
- K181775 — Quantum Blood and IV Fluid Infusion Warmer
- K182093 — ZOLL ECG Analysis Software
- K182228 — MIS LOCKiT Abutments System, OT-Equators and Ball Attachments
- K182477 — Cervical Spacer
- K183001 — WEGO-PGLA RAPID
- K183004 — WEGO-PGA RAPID
- K183025 — MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component
- K183362 — Venue GO
- K183456 — Aloka Arietta 850
- K180230 — NEST Interbody System
- K180780 — microINR System
- K182078 — MiniCollect K2E K2EDTA Tubes
- K182389 — Sysmex XN-L Automated Hematology Analyzer
- K182480 — Earlens Contact Hearing Aid
- K182548 — Accucuff Cuff Pressure Indicator
- K182642 — GenesisZr 4Y Zirconia
- K182895 — Wilson-Cook Achalasia Balloon
- K182919 — SI-Restore® Sacroiliac Joint Fixation System
- K182968 — Hoffmann LRF System
- K183042 — SMR Lateralized Connectors with screws
- K183228 — HammerToe Compression System
- K183321 — Treace Medical Concepts (TMC) Plating System
- K183468 — Revive Reusable Bladder Support
- K183615 — Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle
- K183631 — medi pneumatic compression system (pcs) brio (Model 651)
- K180183 — Ritter Dental Implant System
- K181056 — Reprocessed CS Diagnostic Electrophysiology Catheter
- K181135 — Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay
- K182297 — Surveyor S2
- K182312 — Zyppah Anti-Snoring Device
- K182363 — BTL-703
- K182514 — Surgical Face Mask
- K182594 — E-CUBE i7
- K182964 — ROSA Knee System
- K183244 — MAGNETOM Lumina
- K183346 — FLOW 90 Wand
- K183541 — ProRad 2FC and ProRad 3NC Stationary Radiographic Systems
- DEN180047 — Aptima Mycoplasma genitalium Assay
- K181387 — Pre-Formed Penile Silicone Block
Data sourced from openFDA. This site is unofficial and independent of the FDA.