FDA 510(k) clearances — page 239
clearances on record, most recent first.
Clearances — page 239
23,801–23,900 of 175,699- K182601 — Vitrea Software Package, VSTP-001A
- K182668 — Rapid Reboot Compression Therapy System
- K182681 — AC5 Topical Gel
- K182790 — Cardio-TriTest v6.5
- K182805 — RCT800
- K182900 — 3880 MRI Patient Monitoring System
- K182905 — UniPulse
- K182922 — MTS Omadacycline 0.002-32 µg/mL
- K183162 — Affixus Hip Fracture Nail
- K180359 — BTL-FR2000
- K180859 — PYRAMIDION Dental Implants and Prostheses
- K181131 — Accu-Chek Guide Me Blood Glucose Monitoring System
- K181372 — Argos
- K181463 — DuraSheath Introducer Sheath System
- K181824 — CBT Screw Fixation System
- K181899 — ROCCIA® PLIF
- K182065 — EVOLUX CAD/CAM PMMA BLOCKS
- K182068 — Erran Dental Zirconia
- K182178 — neoBLUE blanket LED Phototherapy System
- K182359 — HipCheck
- K182397 — Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
- K182434 — LaparoGuard
- K182549 — StatStrip Xpress 2 Glucose Hospital Meter System
- K182552 — StatStrip Xpress Glucose Hospital Meter System
- K183145 — IlluminOss Photodynamic Bone Stabilization System
- K183265 — Selectra Catheters, Selectra Accessory Kit
- DEN170055 — Retrograde Intubation Set
- K180578 — Harvest Dental Polymer Blocks
- K181869 — On1 Universal Abutment
- K182339 — LEUCADIA AUTOLOK Pedicle Screw System
- K182473 — PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems
- K182812 — Medline Cautery Electrode (SILICONE)
- K182954 — Salvo Spine System
- K182997 — enlighten III Laser System
- K183128 — EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2
- K183383 — ANAX OCT Spinal System
- K180999 — Mygen V-1000 RF System
- K181174 — Cardinal Health Sterilization Wrap
- K181625 — Life Spine Resolute Threaded Cage System
- K181744 — BI-MENTUM dual mobility system
- K181920 — Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker
- K182902 — Precision1
- K182946 — Invacare TDX SP2-HD with Captain's Seat
- K183107 — Intuitive Surgical Vessel Sealer Extend
- K183168 — OpenLoc-L Spinal Fixation System
- K183307 — Magma Spark Pro (Magma Spark Plus, Alpha)
- K173681 — reSET-O
- K180533 — Procellera Composite Antibacterial Wound Dressing
- K180831 — CATSmart
- K180945 — LUTRONIC GENIUS Radiofrequency System
- K181405 — Hailie Sensor
- K181498 — X-ray Imaging System for the McLaren Proton Treatment System
- K181675 — FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System
- K181766 — VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance
- K181826 — Glenoid Polyaxial Non-locking Screws
- K181967 — Disposable Temperature Probe
- K182038 — URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer
- K182075 — BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)
- K182280 — ARK Tramadol Assay
- K182491 — Applanation tonometer AT-2
- K182506 — LipiScan Dynamic Meibomian Imager
- K182512 — Route 92 Medical Delivery Catheter
- K182584 — Lucent® XP
- K182724 — CelerityTM 10 STEAM Chemical Indicator
- K182810 — Distal Radius Plating System
- K182831 — SabreLine and SabreGuard Laser Fibers
- K183080 — Mega Plus Spine System
- K172897 — Neck Care Therapy, Model: SYK 509B
- K180175 — SignalMark Lung Biopsy Site Marker
- K180657 — Resin for Temporary Crown & Bridge
- K180670 — ICONN Campbell Interference Screw
- K180679 — CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon Liquid and Powder (Acid Concentrate acidified with Acetic Acid or Na Di Acetate), BicarboCon Liquid and Powder (Bicarb Concentrate), RenaCon Liquid and Powder (Acetate Concentrate with Na Acetate)
- K180754 — C-Zero Pedicle Screw System, Freedom Pedicle Screw System
- K180889 — Tractus Crossing Support Catheter
- K181583 — Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20
- K181695 — Nihon Kohden NKV-550 Series Ventilator System
- K182007 — Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System
- K182048 — Avenir Complete Hip System
- K182183 — GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A
- K182664 — FiXcision
- K182809 — CUSA Clarity Ultrasonic Surgical Aspirator System
- K183100 — Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra
- K183102 — BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody
- K183111 — Contour 24
- K183212 — Nexus DR Digital X-ray Imaging System with stitching
- K183286 — 17HK701G-W
- K163601 — RII Smart IR Thermometer
- K173048 — No-contact Forehead Thermometer
- K173749 — AMRA Profiler
- K181107 — Elevo® Kit Snoring Intervention Device
- K181231 — DePuy Synthes T-PAL Spacer System
- K181357 — PATRIOT® Lumbar Spacers, SUSTAIN® Spacers
- K181529 — Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection
- K181727 — Vivid iq
- K181958 — MagnetOs Putty
- K182006 — Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths
- K182016 — Simplicit90Y
- K182035 — FFRct
- K182125 — EVOLUTION Stemmed CS Femur
- K182373 — PowerLook Tomo Detection V2 Software
Data sourced from openFDA. This site is unofficial and independent of the FDA.