FDA 510(k) clearances — page 223
clearances on record, most recent first.
Clearances — page 223
22,201–22,300 of 176,542- 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
- K191668 — Infrared Forehead Thermometer (Model IR-FT)
- K191723 — ATEC IOM Accessory Instruments
- K191943 — SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set
- K192325 — Quantum Blood and Fluid Warming System
- K192593 — Confirm Rx Insertable Cardiac Monitor
- K192598 — Bashir S-B Endovascular Catheter, Ref. No. 7101
- K192760 — NuVasive Modulus XLIF Interbody System
- K182073 — BcSs-PICNI-2000 Sensor
- K183503 — EasyMark Tissue Marker
- K190102 — DyeVert Plus Contrast Reduction System, DyeTect Contrast Monitoring System, DyeVert Plus EZ Contrast Reduction System
- K190162 — SmartCeph
- K191216 — Voxel Dosimetry v1.0
- K191653 — Freestyle Flex
- K191942 — MT One Diamond
- K192175 — On Call Express II Blood Glucose Monitoring System
- K192239 — WavelinQ Plus EndoAVF System
- K192316 — Matrix HA PEEK Cervical Implant System
- K192441 — Arthrex SwiveLock Anchors
- K192455 — Merge PACS
- K192556 — Carnation Ambulatory Monitor
- K192566 — Reach and CQ'ENCE Circular Staplers
- K190486 — Pitkar External Fixation System
- K190953 — Arthrex Minimally Invasive Ankle Fusion Plate
- K191493 — Ventripoint Medical System Plus (VMS+) 3.0
- K191771 — SECURE Screw
- K192250 — Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL
- K192512 — Focus 35C Detector, Trimax 35C Detector
- K192541 — DigiX FDX
- K190149 — Vial Adapter Ø20 mm
- K190840 — Medtronic Transportation / Sterilization Cassettes
- K191251 — Infared Thermometer
- K191326 — Arthrex Mini Comprehensive Fixation System 1.4mm & 1.6mm Module
- K191672 — NuFACE Mini Device
- K192194 — TotalShield II Surgical Helmet System
- K192434 — DualX Lumbar Intervertebral Body Fusion Device
- K190937 — Echelon Endopath Staple Line Reinforcement
- K183589 — PMT Facet Screw
- K183674 — Electronic Pulse Stimulator
- K183681 — Protego Antimicrobial Wound Dressing
- K190084 — McLean-Ring Enteral Feeding Tube Set
- K190713 — F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large)
- K191181 — NXPRO Neuromuscular Electrical Stimulation Device
- K191208 — Spectra Cashmere
- K191420 — Reusable SpO2 Sensor
- K191480 — Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid)
- K191542 — Apyx Plasma/RF Handpiece
- K191548 — Nexus Universal Self-Cure
- K191684 — MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System
- K191822 — Nano FortiCore, FortiCore
- K191902 — Razor, Everest, U&C Liquid
- K192057 — K-Pack II Needle - 27G x 1/2 Extra Thin Wall, K-Pack II Needle - 27G x 1/2 Ultra Thin Wall, K-Pack II Needle - 30G x 1/2 Extra Thin Wall, K-Pack II Needle - 30G x 1/2 Ultra Thin Wall
- K192214 — CarboClear VBR System
- K192235 — AEON Laparoscopic Instruments
- K192312 — Zimmer Natural Nail System Cephalomedullary Nails
- K192515 — BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20
- DEN190025 — OraQuick Ebola Rapid Antigen Test
- K182136 — Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)
Data sourced from openFDA. This site is unofficial and independent of the FDA.