FDA 510(k) clearances — page 239
clearances on record, most recent first.
Clearances — page 239
23,801–23,900 of 176,542- K190164 — CleverLock Guidewire Locking Device and Biopsy Cap
- K190416 — Dome Electrode
- K190691 — Pixx2430 Digital Diagnostic X-Ray Receptor Panel
- K180232 — DAEHAN Disposable CUP Electrodes
- K182349 — CONCORDE LIFT
- K182597 — Infrared thermometer
- K182872 — LINK GEMINI SL Total Knee System
- K183184 — FlareHawk Interbody Fusion System
- K183376 — HORIZON TMS Therapy System with Navigation
- K190230 — iFuse Implant System®
- K190289 — Karma® Fixation System
- K190520 — VITROS XT Chemistry Products GLU-Ca Slides
- K190557 — Bio-Medicus Insertion Kit
- K190586 — Monster® Screw System
- K181171 — Zimmer Biomet Ceramic Heads
- K182836 — FUJIFILM Endoscope Model EG-740N
- K183320 — Ilumien Optis, Optis Integrated, Optis Mobile
- K190131 — AcQMap High Resolution Imaging and Mapping System
- K190248 — ARIETTA 50
- K181597 — Le'Pen
- K182221 — Bencox Mirabo Cup Multi Hole
- K183343 — Vantage Total Ankle Flat Cut Talar Components
- K190180 — CUSA Clarity Ultrasonic Surgical Aspirator System
- K190198 — Microperimeter MP-3, Microperimeter MP-3 Type S
- K190447 — 7400 Ultrasound Systems
- K190629 — DBSWIN and VISTAEASY Imaging Software
- K180903 — 3880 MRI Patient Monitoring System
- K180924 — Reflect Implant System
- K181352 — Loop System
- K181770 — Intrauterine Access Balloon Catheter, Selective Salpingography Catheter
- K181777 — AggreGuide A-100 ADP
- K182123 — ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card
- K182164 — Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand
- K182609 — Delphos Implants Rigid Fixation System
- K182720 — Freedom Spinal Cord Stimulator (SCS) System
- K182834 — CS-series-FP with Optional ROI Accessory CA-100S
- K182965 — BL-Cart IOL Delivery Cartridge
- K182981 — Confirm Rx Insertable Cardiac Monitor
- K183210 — Thoracic VCAR with GSI Pulmonary Perfusion
- K183508 — Micro Transgastric-Jejunal Feeding Device
- K183579 — Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits
- K183596 — Klassic Knee System - Klassic Knee PS-Post Femur +2 more
- K190023 — BTL-084
- K190178 — Monaco RTP System
- K190648 — Pusen Eview Medical Video Endoscope Image Processor
- DEN180012 — LOADPRO Intraoperative Rod Strain Sensor
- DEN180024 — Leica FL400
- K181505 — V.A.C. DERMATAC Drape
- K181745 — FUJIFILM Duodenoscope Model
- K182176 — Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs
- K190186 — Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System
- K190303 — AirSeal
- K181735 — Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set
- K181882 — eKuore One electronic interface for stethoscope
- K181929 — MiMo(TM) Negative Pressure Wound Therapy System
- K182738 — Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine)
- K182821 — Accutorr 7/VS-900/VS-900c Vital Signs Monitor
- K182835 — WOLF Thrombectomy Device
- K183105 — Mimics Medical
- K183410 — AMSCO 600 Steam Sterilizer
- K190073 — Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub
- K190242 — Tyto Thermometer
- K190302 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit
- K190446 — Responsive Arthroscopy Wedge Push-In Suture Anchors
- K190490 — VITROS XT Chemistry Products TRIG-CHOL Slides
- K181658 — MobileECG 2 BT
- K181817 — transGlideXT Expandable Introducer
- K181858 — Electric Handpiece Motor
- K182897 — Velano Vascular Q2 Extension Set
- K182947 — Dental Pain Eraser
- K183154 — SM Electrodes
- K183628 — Arthrex TensionLoc System
- K190232 — Synapse PACS
- K190392 — WaveLight FS200 Patient Interface
- K190404 — OTIS Optical Coherence Tomography SYstem
- K181716 — InTouch Thermal Camera
- K181778 — MUTARS Proximal Femur Replacement System
- K181905 — AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System
- K190015 — Ballancer Gold, 1212
- K190093 — Rezum Delivery Device, Rezum Generator
- K183491 — Arm Blood Pressure Monitor
- K181173 — ELMED Laparoscopic Instruments and Accessories
- K181360 — ON-Q* Pump with Bolus
- K181624 — Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line
- K181722 — Polyethylene Catheter
- K181738 — Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors
- K181959 — HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)
- K182186 — CMOS Video-Rhino-Laryngoscope System
- K182395 — OARtrac System
- K182554 — Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs
- K182700 — Nexstim Navigated Brain Therapy (NBT) System 2
- K182848 — ROSA ONE Spine application
- K182861 — Shiley Neonatal/Pediatric Tracheostomy Tube
- K182887 — Masimo Rad-67 Pulse CO-Oximeter and Accessories
- K182948 — Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs
- K183047 — Nalu Neurostimulation System
- K183164 — uWS-MR
- K183353 — Telescope Guide Extension Catheter
- K183400 — EnVisio Navigation Sytem
- K183608 — Aristotle 18 Guidewire, 200cm, Soft Profile +2 more
Data sourced from openFDA. This site is unofficial and independent of the FDA.