FDA 510(k) clearances — page 128
clearances on record, most recent first.
Clearances — page 128
12,701–12,800 of 176,479- K223292 — TempSure System
- K211507 — Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)
- K212736 — Canady Flex RoboWrist
- K213427 — PRIMED Pediatric Facemask
- K220663 — AccuCTP
- K221123 — WISE Cortical Strip (WCS)
- K221250 — EasyOne Filter
- K221412 — ARIX Rib System
- K221471 — E3 and Profile
- K221499 — Minimally Invasive Prostate Surgery Navigation System
- K221530 — ANNE Pediatric
- K221608 — NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether
- K221624 — Avenda Health AI Prostate Cancer Planning Software
- K221704 — HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI)
- K221716 — CINA
- K221946 — LED Light Therapy Mask (model: MK66R-B)
- K222009 — aprevo® anterior lumbar interbody fusion device with interfixation
- K222052 — VitroPRO
- K222054 — Denti.AI Auto-Chart
- K222160 — GUS610 Blood pressure monitor
- K222237 — Cala kIQ
- K222895 — DynamicIQ
- K222964 — BioPoly Lesser Toe Hemiarthroplasty Implant
- K222992 — iRoot BP Root Repair Material BioAggregate Paste +2 more
- K223041 — Renasys Edge (66803126)
- K223080 — da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)
- K223152 — Vision 2, EVARVision, TrackVision 2, HeartVision 2
- K211358 — Implanter incl. Accessories
- K212936 — Vision Monitor- MonCvONE
- K220846 — CORE-SNARE
- K221069 — Infusion Sets for Single Use with Needles
- K221075 — Infusion Sets for Single Use
- K221078 — Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use
- K221268 — SR-1 Skin Treatment System
- K221811 — Vista BC Sealer
- K222246 — Disposable Sterile Lancet
- K222372 — Kowa SL-19
- K222390 — Flex-Thread Ulna Intramedullary Nail System
- K222420 — Disposable Blood Pressure Cuff
- K222645 — Treace Medical Concepts (TMC) Implant Fixation System
- K222951 — SM-V
- K222980 — Pentax Medical Valve Set
- K223032 — SIS System (Version 5.6.0)
- K223257 — Miro3D Wound Matrix
- K221165 — Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl
- K221282 — Empatica Health Monitoring Platform
- K210623 — FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2
- K212911 — Konig Mogen Clamp
- K213018 — Auxilock GFS Mini, GFS II Large, and GFS Ultimate
- K220351 — Polso Watch
- K220658 — COSY Cervicothoracic Occipital Rod-Screw System
- K221330 — BriefCase
- K221369 — FBCC Night Guard
- K221580 — Single-Use Flexible Cystoscope
- K221581 — Single-Use Flexible Rhinolaryngoscope
- K222189 — SiOxD Wound Matrix
- K222455 — Calibrate LTX Interbody System
- K222477 — Hair Growth Device
- K222493 — CODA Anterior Cervical Plate System
- K222496 — Electromed SmartVest Airway Clearance System
- K222535 — OCS Lung Donor Flush Set
- K222539 — Facet Blood Lancets
- K222701 — MANTA Laser
- K222816 — Opulent TiNbN Coated Knee
- K222903 — Tailored-H Cervical Stand Alone System
- K223003 — Banded Face Mask
- K223124 — EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG
- K223246 — Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense
- K223293 — CONTOUR® NEXT GEN Blood Glucose Monitoring System
- K211265 — TFX-LT2000 Therapy Light
- K212910 — Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece
- K213042 — Supra Non-Stick Bipolar Forceps
- K213295 — C.C. LIFE 21
- K220042 — Dentca Base Premium, Dentca Base Hi-Impact
- K220558 — Blood Administration Sets
- K220739 — Disposable Urine Collection Tube
- K220820 — Parky App
- K220905 — xvision Spine System
- K221178 — Disposable Insulin Pen Needle
- K221281 — Multitom Rax
- K221479 — Persona Personalized Knee System
- K221593 — Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus
- K222109 — Accure Laser
- K222208 — Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D
- K222476 — OmegaAI Image Viewer
- K222518 — FX Contra
- K222598 — IPL Hair Removal Device
- K222673 — Alexandrite and Nd:YAG Laser models CANLASE and TORLASE
- K222973 — IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody Sytem
- K223227 — MAVEN Patient-Specific Instrumentation
- K223267 — SKR 3000
- K223278 — easy Claire
- K203528 — KNH Surgical Face Mask
- K212812 — Surgical Gown
- K220302 — Disposable surgical face mask
- K220465 — PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10
- K220533 — Endoscopy Oxygen Mask
- K220635 — Heater-Cooler System 3T
- K220841 — PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)
- K221094 — OmniTaper EV Dental Implants, DS Implants abutments with EV connection
Data sourced from openFDA. This site is unofficial and independent of the FDA.