FDA 510(k) clearances — page 238
clearances on record, most recent first.
Clearances — page 238
23,701–23,800 of 175,699- K180826 — Natrelle 133 Plus MICROCELL Tissue Expander
- K181037 — DIO CAD/CAM Abutment
- K181120 — 2.8 mm/3.3 mm PopLok Suture Anchors
- K181331 — JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White
- K181412 — VITEK MS
- K181555 — Arthrex Fracture Adapter Hemi Shoulder Prosthesis
- K181690 — Clear-Jet Injection Catheter
- K181752 — Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)
- K182012 — ADVIA Centaur Calcitonin (CALCT) assay
- K182032 — SterilContainer S System
- K182167 — The ICHOR Panacea Vascular Embolectomy Catheter System
- K182682 — OrthoGold 100
- K182690 — ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel
- K182750 — 4D View
- K182755 — Disposable Temperature Probe
- K182776 — Neocis Guidance System
- K182781 — PTS Professional Chemistry Kit
- K182795 — LENSAR Laser System - fs 3D (LLS-fs 3D)
- K183012 — vascuCAP
- K183059 — 3nethra neo
- K183068 — Nitrile Glove Powder Free White
- K183328 — Pulse Rx 2.0, Pulse Pro Rx 2.0
- DEN170021 — SEM Scanner (Model 200)
- DEN170072 — Enlight 1810
- K162553 — AirSpiral Heated Breathing Tube
- K173041 — 3DIEMME RealGUIDE
- K180828 — Natureplex Warm Touch Warming Jelly
- K180830 — Reuter Tip Deflecting Wire Guide
- K181589 — Curiteva Lumbar Interbody Fusion System
- K181663 — ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel
- K181838 — Sinusway Dilation System
- K181861 — Embrace
- K182165 — Color Doppler Ultrasound System; Model: mEye1 and mEye2
- K182320 — BD Contoured Base Pen Needle
- K182420 — ASAHI Corsair Pro XS
- K182454 — O2 Concepts Oxlife Independence Model 301-0001
- K182670 — FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute
- K182972 — Phoenix Atherectomy System
- K183036 — Dilator Sets
- K183115 — MTS Levofloxacin 0.002 - 32 µg/mL
- K183123 — microTargeting Guideline 4000 5.0 System
- K183267 — DyeVert NG Contrast Reduction System, DyeVert PLUS EZ Contrast Reduction System, DyeTect Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert PLUS EZ Contrast Reduction System
- K173140 — VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitoring System, VivaChek Ino Sound Bright Blood Glucose Monitoring System
- K180846 — Arterial Pressure Monitoring Set/Tray
- K180863 — FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator
- K181785 — Modified BrainScope One
- K182116 — BA310 Abutment, BIA310 Implant/Abutment
- K182149 — FFRangio System
- K182190 — Fetal Doppler
- K182446 — TruShot with Y-Knot All-Suture Anchor
- K182610 — Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device
- K183223 — Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
- K183239 — CoreLink F3D Lateral System
- K180909 — REVEL Spacers
- K181087 — Apex Locator, DPEX III
- K181496 — VINTAGE PRO
- K181756 — Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.