FDA 510(k) clearances — page 349
clearances on record, most recent first.
Clearances — page 349
34,801–34,900 of 175,770- K150779 — LipoFilter - Hospital Pack, LipoFilter - Clinic Pack
- K150801 — Stryker Maestro Air Motors
- K150941 — Somnowell Mandibular Advancement Appliance (MAA)
- K151076 — MicroTaper Needle Introducer Set
- K151102 — Bausch + Lomb Injector System
- K151222 — Cautery Tip Cleaner
- K142895 — LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators
- K143060 — Intelli-Ox
- K143436 — InvisionECG System
- K143603 — Darlinghurst Vented, Darlinghurst NV-AAV
- K143660 — Milagro / Milagro Advance Interference Screw
- K150151 — SmartGownTM surgical gown
- K150297 — PlasmaBlade UPPP and Suction Coagulator
- K150446 — Erchonia Zerona 6 headed scanner EZ6
- K150467 — Retina Workplace
- K150733 — Vital-Port Vascular Access System Power Injectable Port
- K140491 — TANAKA ZIRCOLOR COLORING LIQUID, TANAKA ZIRCOLOR DIPPING LIQUID AND TANAKA ENAMEL ZR BLOCKS
- K141748 — RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CALIBRATOR SET, RAPIDFRET ORAL FLUID AMPHETAMINE CONTROL SET
- K141900 — SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE
- K142422 — cobas Cdiff Test
- K142719 — E-App
- K142724 — BIOFOAM Bone Wedge
- K143502 — Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls
- K143511 — K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal Lubricant
- K143562 — Reprocessed Cordless Ultrasonic Dissection Device
- K150090 — Zimmer Persona Personalized Knee System
- K150453 — TULA Iontophoresis System with Earset
- K150461 — StatStrip Xpress Glucose Hospital Meter System
- K150848 — Dose Calculator
- K151055 — Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE
- K141351 — SUPERCHECK PLUS BLOOD GLUCOSE MONITORING SYSTEM, SUPER CHECK PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM
- K142291 — GMX Series Medical Air/Oxygen Blender
- K142567 — RETeval Visual Electrodiagnostic Device
- K143561 — ELM PTA Balloon Dilatation Catheter
- K143629 — U&U Bowie-Dick Test Pack
- K150061 — Lucent; Lucent Ti-Bond Systems
- K150187 — ELITECROSS Support Catheter
- K150417 — ASTRA SPINE SYSTEM
- K151236 — MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal)
- K142486 — HEINE BETA 200, HEINE BETA 200 S, HEINE K 180
- K150026 — Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler
- K150785 — syngo.CT Dental
- K141168 — ANSISTIM
- K141883 — CLINISCANSM EEG
- K142516 — Propeller System
- K142729 — Chi Lites Orthodontic Sapphire Bracket
- K143242 — Rebel 3DKNEE System
- K143294 — Adaptive Motion Correction (AMC), CSMC-001A and 4D Airways
- K143643 — Brainscope Ahead 200
- K143694 — Rhondium One-Visit-Crown(OVC)
- K143728 — Minhua Disposable Blood Pressure Cuff
- K150230 — SculpSure
- K150284 — IS4000 da Vinci EndoWrist Instruments
- K150407 — BioFlo Midline Catheter
- K150424 — JuggerStitch Meniscal Repair Device
- K150521 — Interbody Fusion (IBF)/Vertebral Body Replacement(VBR) System
- K150547 — .decimal Astroid Dosimetry App
- K150691 — Datalys Multi-Parameter Patient Monitor
- K150822 — Centurion POCT System
- K150900 — Flexicare Heated Wire Breathing Systems
- K151078 — Arthrex RetroFusion Screw
- K151097 — Active Breathing Coordinator
- K151175 — ZONARE ZS3 Diagnostic Ultrasound System
- K140150 — Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood Glucose Monitoring System, Goodlife AC 303 Blood Glucose Monitoring System, Goodlife AC-304 Blood Glucose Monitoring System Goodlife AC-305 Blood Glucose Monitoring System, Goodlife AC-300 Professional Blood Glucose Monitoring System, Goodlife AC-301 Professional Blood Glucose Monitoring System Goodlife AC-30
- K141057 — DISPOSABLE CERVICAL BRUSH
- K141863 — PURICORE WOUND HYDROGEL SPRAY DRESSING
- K142319 — SCIg60 Infuser, Infuset
- K142629 — EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes
- K143078 — Bookwalter Gordon Adjustable Compression Element
- K143326 — T.A.G. Dental Implant System
- K143435 — Planmed Verity
- K150171 — Tinnitus Sound Generator Module
- K150458 — Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere
- K141886 — MDK HANDPIECES
- K142504 — SpineFrontier Lumbar Interbody Fusion Device System
- K150226 — Hematocrit and Metabolite QUALICHECK
- K150310 — IntelliVue Patient Monitor
- K150356 — Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
- K151017 — JMS Harmony A.V. Fistula Needle Set
- K143196 — syngo.CT Lung CAD
- K150161 — Venus Viva SR Device
- K150185 — Mont Blanc Spinal System
- K150224 — BLUE VINYL GLOVES POWDER FREE
- K150341 — Miromatrix Biological Mesh RS
- K150539 — OASYS System
- K150675 — Dorsal Spanning Plate
- K150681 — GEMORE OTC TENS
- K150970 — Coda LP Balloon Catheter
- K142055 — GYMFORM ABS & CORE
- K142260 — NobelActive
- K142543 — Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control
- K143647 — Renovis Surgical Hip Replacement System
- K150125 — Elite Nitinol Fixation System
- K150126 — Life Spine Cannulated Screws
- K150152 — The Octane Straight Intervertebral Fusion Device, Ti Coated
- K150345 — Magic3 Go Intermittent Urinary Catheter
- K150533 — Terason uSmart3200T Ultrasound System
- K140905 — DERMAFINE
- K142103 — CUFF PILOT, SURE SEAL
- K143399 — Stryker Footed Attachments and Cutting Accessories
Data sourced from openFDA. This site is unofficial and independent of the FDA.