FDA 510(k) clearances — page 119
clearances on record, most recent first.
Clearances — page 119
11,801–11,900 of 176,479- K220398 — Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire
- K221129 — CloudTMS for OCD
- K221198 — Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL
- K221292 — Uni Knee Resurfacing System
- K221623 — FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm
- K222478 — BD Vacutainer® Luer-Lok Access Device, BD Vacutainer® Blood Transfer Device
- K222718 — Vial Adapter
- K223175 — lntravascular Administration Sets with Stopcock and Manifold
- K223325 — uMI Panorama
- K230295 — ATTUNE® Revision Cones
- K230349 — Lyra RSV+hMPV Assay
- K230433 — Arthrex Knotless FiberTak Suture Anchor
- K221301 — DESS Dental Smart Solutions
- K221373 — Essenz HLM
- K221700 — AutoPulse NXT Resuscitation System
- K221706 — AccuContour
- K221816 — Wesper Lab
- K221919 — DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets
- K221930 — CEREGLIDE 71 Intermediate Catheter
- K221934 — CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set
- K222430 — VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin
- K222663 — MultiStage Balloon Dilatation Catheter
- K222875 — Powered Muscle Stimulator (Model name:MagGraver F200)
- K223432 — Vassallo GT 018 Hybrid
- K223514 — Spectral Bone Marrow
- K223642 — LED Lip Perfector, model: ZC-05
- K223693 — Electric breast pump (model: M5)
- K223790 — Huvex Interspinous Fusion System
- K230363 — CPS Locator 3D Delivery Catheter
- DEN220039 — Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set
- K213906 — extriCARE 1000 Negative Pressure Wound Therapy System
- K220101 — Pulse Oximeter
- K220613 — Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia
- K220966 — SINEFIX
- K221209 — PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops
- K222007 — Arthrex Virtual Implant Positioning (VIP) System
- K222098 — ManaSport+
- K222136 — Cryo-Thermo Compression Device (FGK002)
- K222355 — PathKeeper System
- K223681 — Respiree Cardio-Respiratory Monitor
- K223688 — CONDUIT Lateral Lumbar Intervertebral Fusion Cage, CONDUIT Instruments
- K223742 — Dental Ceramic Blocks
- K230076 — Enhanced AURORA Medical Diode System, and related accessories
- K230321 — Persona Personalized Knee System
- K213892 — Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine
- K220407 — Visby Medical Sexual Health Test
- K220549 — MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014
- K221883 — Solero Microwave Tissue Ablation (MTA) System and Accessories
- K222465 — Tyber Medical Anatomical Plating System
- K222897 — Enlight 2100
- K223024 — MedCAD AccuPlan System
- K223401 — Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)
- K223726 — Aquilion Precision (TSX-304A/4) V10.14 with AiCE
- K230301 — Athena III Cervical Plate System
- K230331 — Protrieve Sheath
- DEN210033 — Lenire Tinnitus Treatment Device
- K212161 — Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories
- K221158 — Single-Use Video Flexible Ureterorenoscope System
- K221621 — Pro-X1 Trochanteric Nailing System
- K222445 — LC ChromeFlow
- K222457 — Provata Implant System
- K222672 — Disposable Insulin Syringe
- K223232 — Procedure mask/Surgical mask/Face mask
- K223653 — BD Vaginal Panel
- K223930 — A1417MCW/A1717MCW/F1417MCW
- K230315 — Materialise Shoulder System Materialise Shoulder Guide and Models SurgiCase Shoulder Planner
- K230383 — Savvy Surgical Mask - Level 3
- K223452 — Nitronox Scavenger Plus
- K212696 — Aspira Pleural Drainage System
- K221084 — Dyna Locking Trochanteric Nail
- K221587 — DHX-70H, XTG-70H
- K221652 — NIKKICART
- K221661 — Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)
- K221697 — INJECTION PIN (KIP(02031-02061) (03031-03061))
- K221713 — Polypectomy Snare
- K222379 — Alinity m STI Assay
- K222394 — Electronic Sphygmomanometers
- K222447 — FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System
- K222573 — imani i2Plus Breast Pump
- K222819 — Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i
- K222880 — Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)
- K223589 — Grappler Suture Anchor R3FLEX IOL System
- K223776 — PEEK Spinal Infusion Cage
- K230009 — EZ Bond Universal
- K230060 — Light Based Hair Removal Device GP592
- K230236 — Lyra Influenza A+B Assay
- K230256 — Rebellion, Phantom Multi-Bite Kerrison Rongeur
- K230294 — CoverScan (CoverScan v1.1)
- K221340 — iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210)
- K221696 — ReWalk P6.0
- K222176 — BoneView
- K222603 — 6F Wallaby Long Sheath
- K222884 — Rapid NCCT Stroke
- K223203 — 1.5T 24E Posterior Array
- K223352 — Tenderfoot
- K223436 — Artix AX
- K223440 — Plasma Pen (Plasma MD); Plasma Pen (Plasma +)
- K223453 — Insulin Syringe
- K223602 — Traumatic brain injury (TBI) test
- K223628 — NEBA® Compact EEG2R Mobile Headset
Data sourced from openFDA. This site is unofficial and independent of the FDA.