FDA 510(k) clearances — page 123
clearances on record, most recent first.
Clearances — page 123
12,201–12,300 of 176,479- K221619 — ECHELON Oval V6.2 MRI System
- K221949 — Ortho Device, ADAPTIX 3D Orthopedic Imaging System
- K222056 — Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee
- K222403 — Surgical Gown
- K222437 — Aristotle Colossus Guidewire
- K222589 — Flexible Suturing System with Anchors (FSSA)
- K222779 — Revogene
- K223415 — Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K223588 — PALLAS Premium
- K220114 — PowerPAK Syringe
- K221150 — Advanced Bone Plate
- K222665 — Medline UNITE® Ankle Fusion Plating System
- K222801 — Safety Lancet
- K223306 — SPRINT Peripheral Nerve Stimulation (PNS) System
- K223314 — Disposable Blood Lancets
- K223563 — OsteoCNX
- K223847 — CREED Cannulated Screws
- K223866 — Carevix Suction Cervical Stabilizer
- K222818 — Xpedition Powered Stair Chair (625700000000)
- K222879 — Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)
- K203689 — Tidepool Loop
- K221494 — Quality Mix Blender, Oxymixer
- K222406 — Clarius AI
- K223158 — LigaSure XP Maryland Jaw Sealer/Divider
- K223313 — Disposable Safety Lancets
- K223494 — CD Horizon Spinal System
- K222531 — Synthetic Polymer Glove - Polyethylene (Black)
- K222832 — Sentimag System
- K223118 — OIC Variable Angle Small Fragment Locking Plate System
- K223516 — VX1+
- K203792 — Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle
- K214077 — Digital Thermometer, Model: DT007, DT008
- K221419 — TD-5010 Lancing Device and TD-5084 Sterile Lancets
- K221683 — CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR)
- K221725 — Advanced MyHip Planner
- K221899 — The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml
- K222158 — Capiflo 5001
- K222462 — Semi-automatic Biopsy-Needle (9 models)
- K222510 — Blueprint Mixed Reality system
- K222848 — pRESET Thrombectomy Device
- K222889 — FlowArt® Needle-Free Split Septum Valve
- K223177 — Highlander 014 PTA Balloon Dilatation Catheter
- K223404 — Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V
- K223521 — ZESPIN SI Joint Fusion System
- K223528 — Triathlon® Hinge Knee System
- K223548 — GMK Sphere & GMK SpheriKA Cementless
- K223842 — DRX - Compass
- K211197 — Disposable Endoscopic Cutter Stapler and Cartridge
- K213175 — No Stress Impress
- K213772 — LM-9300 Plus Lithotripter
- K220059 — Biosci Inactivated Transport Medium, Biosci ITM
- K220448 — Disposable Non-invasive EEG Sensor
- K221163 — Tunnel Crossing Catheter
- K221522 — HF-cables (resusable)
- K221627 — PerfusionGo Plus
- K222252 — Self-adhesive Electrode
- K222554 — EL CAPITAN Anterior Lumbar Interbody Fusion
- K223108 — TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)
- K223166 — Medaica M1 Telehealth Stethoscope
- K223250 — Disposable Nitrile Examination Glove
- K223503 — Access 25(OH) Vitamin D Total
- K223540 — AvalancheLase Family
- K223872 — Low Profile Companion Sheath
- K211759 — Selux AST System; Model AST Gen 1.0
- K213597 — MultiCut Solo
- K221088 — Anatomic Bone Plate
- K221726 — Uni-FuZe-C Bone Strip
- K222000 — Transit-Pellets
- K222593 — TruPlan Computed Tomography (CT) Imaging Software
- K223107 — MOLLI 2
- K223446 — eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)
- K223804 — PercuNav Image Fusion and Interventional Navigation System
- K223819 — SI-Cure Sacroiliac Joint Fusion System
- K213655 — HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)
- K220649 — Elucis
- K220884 — Disposable Endoscope Valve Sets
- K221754 — Ag Foam Dressing Non-Adhesive (OTC) +3 more
- K222941 — Halcyon, Ethos Radiotherapy System
- K223010 — Portable X-ray System
- K223222 — Plasma IQ
- K223794 — hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
- K223795 — FairFix QT Adjustable Button
- K223800 — MIM Additional Tracers
- K213514 — Spectricept Skin and Wound Cleanser
- K214078 — Silkn Toothwave
- K220495 — SignaSure Dual Mobility System
- K221020 — Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F
- K221252 — Scivita 4KINSIGHT ICG Imaging System
- K221317 — S-Mono
- K221542 — Galileo Vertebral Body Replacement Device
- K221682 — Ideal Med Pro 3-Ply Disposable Face Mask
- K221755 — Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing
- K221933 — MONTAGE Settable, Resorbable Bone Putty
- K222170 — Power Acute Triple Lumen Hemodialysis Catheter
- K222171 — Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+
- K222782 — Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199; YD-1193S,YD-1195S,YD-1196S,YD-1198S,YD-1199S)
- K222913 — s-Clean Link Abutment
- K223031 — Vibrant System
- K223183 — Light-Guide Cables
- K223221 — Non-Sterile Powder Free Nitrile Examination Gloves
Data sourced from openFDA. This site is unofficial and independent of the FDA.