FDA 510(k) clearances — page 357
clearances on record, most recent first.
Clearances — page 357
35,601–35,700 of 176,542- 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
- K143462 — AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)
- K143531 — Rapid Therapy System
- K143606 — MultiBand SENSE
- K150138 — Aspen Laser Systems Therapy Laser System
- K150213 — Subtalar Spacer System (STS)
- K150217 — ORTHOPHOS SL
- K150333 — MedSource Sharps Dart
- K150342 — Touch Ultrasound
- K150530 — Level Sensor, Level Sensor Tape
- K150620 — 740 SELECT
- K150636 — VariSeed 9.0
- K150706 — VitalBeam
- K150772 — Snap-Off Self-Compressive Screw
- K150816 — Jumong Series
- K150946 — FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm x 12mm x 80cm, FLASH Ostial System OTW-7.0mm x 12mm x 135cm
- K151007 — 21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550)
- K142032 — MRI PATIENT MONITORING SYSTEM TESLA M3
- K142192 — Insightra Freedom Ventral Hernia Repair System
- K142482 — The Vest Airway Clearance System
- K142487 — Chesapeake Stabilization System
- K142717 — Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye Contact Lens Case
- K142744 — Mecta-C TiPEEK
- K143147 — Gemini Bonded Sterilization Wrap
- K143185 — entré Model PD08-U
- K143467 — FORA GD43 Blood Glucose Monitoring System
- K143667 — GC KommonBase
- K143750 — MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System
- K143759 — JAZZ System
Data sourced from openFDA. This site is unofficial and independent of the FDA.