FDA 510(k) clearances — page 315
clearances on record, most recent first.
Clearances — page 315
31,401–31,500 of 175,699- K161333 — TightRail Sub-C Rotating Dilator Sheath
- K152564 — Gemini Sterilization Wrap
- K153234 — AirLife Adult Heated Wire Circuit
- K153240 — Styrker OrthoMap Express Knee System
- K160088 — Cydar EV
- K160722 — CorticaLINK Spinal Fusion Platform
- K161305 — Habib EUS RFA
- K153017 — Voyant Fine Fusion
- K153074 — Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal
- K153231 — G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer
- K160433 — V-PRO® 1 Plus and V-PRO® maX Low Temperature
- K160439 — SunTech CT40 Spot-check Vital Signs Device
- K160557 — Full Automatic (NIBP) Blood Pressure Monitor
- K160569 — NeuGuide
- K160830 — Integra External Fixation System
- K160956 — LD-Oxi system
- K160996 — Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm
- K160997 — GC85A
- K161012 — Easy-Load Lens Delivery System
- K161044 — AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)
- K161296 — Cool Renewal
- K161314 — FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE
- K161345 — RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR
- K161395 — SPEC Model M13
- K161553 — BD SafeAssist
- K153145 — Lumipulse G TP-N Immunoreaction Cartridge Set
- K153399 — LightStim Professional LED Bed
- K153533 — Tearaway Introducer Sheath, MicroSlide Tearaway Introducer
- K160607 — PicoWay Laser System
- K160947 — LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System
- K153674 — Sorbact Foam Gentle Border, Sorbact Superabsorbent
- K160604 — Cure Anterior Cervical Plate (ACP) System
- K160904 — Expedium Spine System, VIPER and VIPER 2 Systems
- K161302 — PC ECG
- K161523 — INDIGO Aspiration System
- K161531 — IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800
- K153136 — Initial LiSi Press
- K153177 — Admira Fusion Flow
- K153372 — Repagyn vaginal suppositories
- K153645 — VITA ENAMIC Implant Solutions (IS)
- K153689 — STERIZONE Sterilizer
- K153740 — RTHawk, HeartVista Cardiac Package
- K153749 — 3 Series Phototherapy Unit
- K160235 — ViaValve Safety I.V. Catheter
- K160441 — Identic and KromaFaze Alginate Dental Impression Materials
- K160644 — Lelo Hex Natural Rubber Latex Condom
- K161247 — Relizorb
- K161495 — ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)
- K161522 — LIAISON EBV IgM Serum Control Set
- K161526 — LIAISON CMV IgM Serum Control Set
- K161539 — Arthrosurface Bone Screws
- K161556 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit
- K151986 — ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material
- K152501 — Spinal Jaxx Interbody Fusion Device
- K152737 — Lite Touch
- K153273 — MySpine Pedicle Screw Placement Guides - LP
- K153360 — ADMIRE
- K160130 — BloodSTOP iX Battle Matrix
- K160578 — Nustat XR
- K160752 — HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length
- K160763 — ally Liquid Personal Lubricant
- K160770 — Vent-Os Sinus Dilation family
- K160878 — OPTIS Metallic Stent Optimization E.4 SW
- K160901 — Xpert Carba-R
- K161186 — Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)
- K161285 — Ablation Confirmation
- K152350 — Regular and Special Umbilical Cord Clamp and Cutter
- K152606 — Jeesung Safety Syringe and Single Use Needles
- K153078 — LED Curing Light GT-2000
- K153312 — SCATTER CORRECTION FOR CXDI SERIES
- K153393 — PowerMidline Catheter
- K153739 — MRI Patient Monitor TeslaDUO
- K160584 — Surgical Navigation Advanced Platform (SNAP)
- K160697 — Gibralt® Spine System and Gibralt® Occipital Spine System
- K160820 — PressON Pro Spinal Fixation System
- K160874 — Nanovis Intervertebral Body Fusion System and FortiCore®
- K160911 — VIDAS B.R.A.H.M.S. PCT (PCT)
- K160916 — CoRoent® Ti-C System
- K160926 — F1 MPS Modular Pedicle Screw System
- K161024 — Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape
- K161479 — hipEOS
- K151976 — Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode
- K160853 — Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System
- K161214 — Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard)
- K161482 — EndoChoice Water Bottle Cap Irrigation System
- K152122 — Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)
- K152339 — Unifine Pentips/ Unifine Pentips Plus
- K152585 — Resmon PRO FULL
- K152843 — Liger Medical HTU-110
- K153033 — Digital Blood Pressure Monitor
- K153201 — SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System
- K153517 — AnyPlus® Cervical PEEK Cage System
- K153692 — Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer
- K160430 — Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System
- K160511 — Naya Breast Pump System
- K160523 — BrightMatter Guide with BrightMatter Pointer
- K160669 — ClariFix Device
- K160891 — Ultrathane Endoureterotomy Stent Set
- K161136 — Precision Treatment Planning System
- K161144 — iDMS Data Management System
Data sourced from openFDA. This site is unofficial and independent of the FDA.