FDA 510(k) clearances — page 119
clearances on record, most recent first.
Clearances — page 119
11,801–11,900 of 175,620- K222710 — IPL Cooling Hair Removal Device
- K223226 — Trigon HA Stand-Alone Wedge Fixation System
- K212717 — Paneffort AAMI Level 3 Isolation Gown
- K220254 — Neuron-Spectrum-AM with Neuron-Spectrum.NET Software
- K221082 — Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl
- K221771 — EEA Circular Stapler with Tri-Staple Technology
- K222044 — Elos Accurate Customized Abutment
- K222299 — Steripath Micro Blood Collection System
- K222305 — MissLan Digital Pregnancy Rapid Test
- K222472 — Lancing System, Sterile Lancet for Single Use, Lancing Device
- K223328 — Purgo
- K213917 — QStat Cartridge
- K213943 — SmartSurgN Visualization System
- K222408 — Disposable Safety Lancet
- K222641 — Signia Small Diameter Reloads Including Regular (Round) Tip Version
- K211050 — Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304
- K220630 — TorchTM Software
- K221279 — pNOVUS 21 Microcatheter
- K221556 — T-Line Hernia Mesh
- K222363 — Aevumed PHANTOM-LP Suture Anchors
- K222611 — Male Latex Condoms
- K222652 — Aneroid Sphygmomanometer; Single Patient Use Aneroid Sphygmomanometer
- K223039 — da Vinci E-200 Electrosurgical Generator
- K223099 — Facet Manatee Reusable Lancing Base
- K223274 — Momentum® MIS Posterior Spinal Fixation System
- K223009 — Wireless/Wired X-Ray Flat Panel Detectors
- K213215 — VSI HoloMedicine
- K222612 — Powder-Free Latex examination gloves
- K222918 — DentCare Aligners
- K201460 — Closed System Transfer Device
- K213459 — Glenoid Reconstruction System
- K221152 — CuringPen Dental Curing Light
- K221210 — PainShield MD PLUS
- K221815 — Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De); Electrosurgical Pencil (OBS-Dt, OBS-Dd, OBS-Ds, OBS-Dl, OBS-Da)
- K222452 — Disposable Automatically Retractable Safety Syringes (with detachable needle)
- K222463 — EchoGo Heart Failure
- K222534 — Nitrile Patient Examination Glove
- K222569 — Ai Ray Dental X-Ray Device
- K222656 — LDE4 Lancing Device
- K222967 — Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws
- K223068 — Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E)
- 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;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.