FDA 510(k) clearances — page 231
clearances on record, most recent first.
Clearances — page 231
23,001–23,100 of 175,699- 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 ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile
- K190104 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System
- K190252 — MTS Gentamicin 0.016 - 256 µg/mL
- K190430 — OsteoCentric Bone Plate and Screw System
- K173191 — A&D Medical Blood Pressure Monitors
- K181822 — RENASYS Touch; RENASYS Y-Connector
- K182064 — ExpanSure Transseptal Dilation System
- K182074 — Mineral Collagen Composite Bioactive Moldable
- K182918 — Ballast 088 Long Sheath
- K183582 — MPACT Extension
- K183592 — ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer
- K190377 — UroLift System UL400
- K190380 — nvc
- K190412 — CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
- K190418 — NuVasive® VersaTie® System
- K190425 — CastleLoc-P Anterior Cervical Plate System
- K190431 — Route 92 Medical Delivery Catheter
- K182511 — SimplCath
- K183399 — BD Nexiva Closed IV Catheter System
- K183408 — Jensen Shade Effect Liquids
- K183414 — ABSOLU
- K183543 — ACTIV.A.C. Therapy Unit
- K183575 — ACUSON S3000, S2000 Diagnostic Ultrasound System
- K180098 — SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1
- K182383 — Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue
- K182468 — Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System
- K182793 — AP3600 Automated Instrument
- K183019 — SIS Software version 3.3.0
- K183527 — MTS Ciprofloxacin 0.002 - 32 µg/mL
- K183529 — AE-120A EEG Head Set
- K190379 — MIM on Linux
- K190423 — Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System
- K181599 — Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application
- K183260 — Sensilight Pro / Pistol IPL
- K183296 — REAL Immersive System
- K183344 — The Progressive Orthopaedic Company Total Knee System II
- K183511 — Affinity Pixie Oxygenator with Balance Biosurface (Model BBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (Model BBP241), Affinity Pixie Oxygenator with Cortiva BioActive Surface (Model CBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Cortiva BioActive Surface (Model CBP241)
- K183518 — Preat Abutments
- K190204 — ID NOW Influenza A & B 2
- K190333 — Paradigm All-Suture Anchor 1.8mm, White/Black #2
- K190354 — BRAUN Silk.expert Pro 5
- K190361 — Zavation Spinal System
- K190366 — BRAUN Silk Expert Pro 3
- K190359 — Sonendo GentleWave System
Data sourced from openFDA. This site is unofficial and independent of the FDA.