FDA 510(k) clearances — page 247
clearances on record, most recent first.
Clearances — page 247
24,601–24,700 of 176,542- K182150 — Devon 52 Sequential Compression Device
- K182361 — Arthrex Compression FT Screws
- K182422 — Lucitone Denture Base Materials
- K182424 — NuFACE FIX Skin Toning Device
- K182593 — KET-1 Blood Ketone Monitoring System
- K182595 — HERA W10 Diagnostic Ultrasound System
- K182624 — MIM - MRT Dosimetry
- K182688 — SKR 3000
- K182747 — EliA RF IgM Immunoassay
- K182878 — Integra Salto Total Ankle System
- K182938 — Emission Computed Tomography System
- K182989 — AURORA Screw System
- K183185 — Riptide Aspiration System (Riptide Large Bore Aspiration System)
- K183253 — ValPro 2 Plus, VaPro 2 Plus Pocket
- K172965 — Handheld VitalSigns Monitoring System
- K180772 — Met One Czar Anterior Cervical Plate System
- K180878 — BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx
- K181612 — Tyto Stethoscope (OTC)
- K181877 — Phoenix 2.4mm Atherectomy Plus System
- K182001 — Acucy Influenza A&B Test with the Acucy System
- K182387 — NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)
- K182433 — Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff
- K183198 — FlowTriever Retrieval/Aspiration System
- K183348 — Reusable Silicone Cover CPRmeter 2
- K173783 — SCIg60 Infusion System
- K180762 — CAPI 3 HEMOGLOBIN(E)
- K180768 — Arthrex SwiveLock Anchors
- K180797 — Xcess Guiding Catheter
- K180820 — Tono Vue Non-Contact Tonometer
- K180879 — BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use
- K181269 — iCertainty
- K181294 — Honda Walking Assist Device
- K181344 — C.T.M Mobility Scooter
- K181374 — NRFit Syringe
- K181827 — Affixus Natural Nail System Humeral Nail
- K181865 — Acu-sInQ Complete Endoscope Cleaning Aid System
- K182008 — Phasix ST Mesh with Echo 2 Positioning System
- K182194 — UV Active Implant System
- K182207 — TR90BH
- K182296 — HyperFil-LV
- K182354 — SafeAir Telescopic Smoke Pencil
- K182419 — Centricity Universal Viewer
- K182556 — SureClip Repositionable Hemostasis Clip
- K182601 — Vitrea Software Package, VSTP-001A
- K182668 — Rapid Reboot Compression Therapy System
- K182681 — AC5 Topical Gel
- K182790 — Cardio-TriTest v6.5
- K182805 — RCT800
- K182900 — 3880 MRI Patient Monitoring System
- K182905 — UniPulse
- K182922 — MTS Omadacycline 0.002-32 µg/mL
- K183162 — Affixus Hip Fracture Nail
- K180359 — BTL-FR2000
- K180859 — PYRAMIDION Dental Implants and Prostheses
- K181131 — Accu-Chek Guide Me Blood Glucose Monitoring System
- K181372 — Argos
- K181463 — DuraSheath Introducer Sheath System
- K181824 — CBT Screw Fixation System
- K181899 — ROCCIA® PLIF
- K182065 — EVOLUX CAD/CAM PMMA BLOCKS
- K182068 — Erran Dental Zirconia
- K182178 — neoBLUE blanket LED Phototherapy System
- K182359 — HipCheck
- K182397 — Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
- K182434 — LaparoGuard
- K182549 — StatStrip Xpress 2 Glucose Hospital Meter System
- K182552 — StatStrip Xpress Glucose Hospital Meter System
- K183145 — IlluminOss Photodynamic Bone Stabilization System
- K183265 — Selectra Catheters, Selectra Accessory Kit
- DEN170055 — Retrograde Intubation Set
- K180578 — Harvest Dental Polymer Blocks
- K181869 — On1 Universal Abutment
- K182339 — LEUCADIA AUTOLOK Pedicle Screw System
- K182473 — PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems
- K182812 — Medline Cautery Electrode (SILICONE)
- K182954 — Salvo Spine System
- K182997 — enlighten III Laser System
- K183128 — EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2
- K183383 — ANAX OCT Spinal System
- K180999 — Mygen V-1000 RF System
- K181174 — Cardinal Health Sterilization Wrap
- K181625 — Life Spine Resolute Threaded Cage System
- K181744 — BI-MENTUM dual mobility system
- K181920 — Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker
- K182902 — Precision1
- K182946 — Invacare TDX SP2-HD with Captain's Seat
- K183107 — Intuitive Surgical Vessel Sealer Extend
- K183168 — OpenLoc-L Spinal Fixation System
- K183307 — Magma Spark Pro (Magma Spark Plus, Alpha)
- K173681 — reSET-O
- K180533 — Procellera Composite Antibacterial Wound Dressing
- K180831 — CATSmart
- K180945 — LUTRONIC GENIUS Radiofrequency System
- K181405 — Hailie Sensor
- K181498 — X-ray Imaging System for the McLaren Proton Treatment System
- K181675 — FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System
- K181766 — VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance
- K181826 — Glenoid Polyaxial Non-locking Screws
- K181967 — Disposable Temperature Probe
- K182038 — URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer
Data sourced from openFDA. This site is unofficial and independent of the FDA.