FDA 510(k) clearances — page 111
clearances on record, most recent first.
Clearances — page 111
11,001–11,100 of 175,620- 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
- K223902 — FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)
- K230093 — Disposable 4 Layers Surgical Face Mask
- K230253 — OPTRELL Mapping Catheter with TRUEref Technology
- K230303 — AccuFFRangio Plus
- K213898 — ProTrack Pigtail Wire
- K220014 — RSHOCK
- K221053 — Magnes-C Anterior Cervical Plate System
- K221680 — Xeleris V Processing and Review System
- K222187 — Multistage Balloon Dilatation Catheter
- K222280 — Bigfoot Unity® Diabetes Management System
- K222975 — Advantis Platform
- K223040 — Endo SmartCap
- K223144 — Galaxy System
- K223423 — 32HQ713D
- K230283 — Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 405422, 405424, 405428)
- K230308 — Alma Harmony
- K221257 — SpectraWAVE Imaging System
- K221641 — Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB)
- K221705 — U2 Total Knee System-PF+
- K221711 — AccuICAS
- K221790 — HARMONIC 700 Shears
- K222240 — EXPLORER AIR® II
- K222481 — PuraStat
- K222507 — Mobility Scooter (Models: W3431Q, W3431R)
- K223116 — 8X-10-6XXX Camera Head
- K223272 — SurBlate Ablation System
- K223392 — REVCON (TM) Screw System
- K223618 — IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD
- K230038 — MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)
- K230245 — LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation System
- K230248 — VIOLA
- K211181 — Idylla MSI Test
- K220035 — Milli Vaginal Dilator
- K222173 — Saneso Lens Wash Bottle Assembly (SAN-LWB-A)
- K223075 — Ogmend® Implant Enhancement System
- K223223 — BENCOX Mirabo Z Cup Cortinium
- K223253 — Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)
- K213431 — Handheld Pulse Oximeter
- K221702 — CompuFlo Epidural Computer Controlled Anesthesia System
- DEN220063 — Caption Interpretation Automated Ejection Fraction Software
- DEN220065 — Pill Sense System
- K211554 — InnoGenic Non-resorbable Membrane
- K213805 — MAGNETOM Vida
- K213891 — RealNow
- K221592 — AVIEW Lung Nodule CAD
- K221614 — TytoCare Lung Sounds Analyzer
- K221845 — Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G
- K222386 — Visionbody
- K222757 — Clarus Viewer
- K223231 — Ti-Largo Cervical Interbody System
- K223582 — MectaLock TI Triple Loaded Suture Anchor
- K223759 — Arthrex SynergyID Endoscopic Imaging System
- K223810 — Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)
- K223852 — VySpan PCT System
- K223884 — ELITONE Urge Urinary Incontinence Device
- K223900 — babyLance Safety Heelstick (BLM, BLN, BLP)
- K230205 — Veloxion System
- K230339 — EsoCheck Cell Collection Device
- K213863 — Everion+ System
Data sourced from openFDA. This site is unofficial and independent of the FDA.