FDA 510(k) clearances — page 120
clearances on record, most recent first.
Clearances — page 120
11,901–12,000 of 176,479- 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
- K221559 — Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3
- K221564 — Brainomix 360 e-ASPECTS
- K221591 — Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source
- K222579 — Belun Sleep System BLS-100
- K223161 — OXY-1 System
- K223209 — Elekta Unity
- K223216 — Symphony Thrombectomy System
- K223229 — MOSAIQ® OIS (Oncology Information System)
- K223233 — Monaco RTP System
- K223262 — Renuvion® APR Handpiece
- K223544 — LED light therapy mask (FM-01, FM-02, FM-03)
- K223797 — Neuro20 Pro System
- K230212 — OrthoButton AL
- K230216 — 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)
- K230227 — T-Line Hernia Mesh
- K230228 — Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)
- K230241 — Jumong General
- K212587 — 3D-RD-S
- K221329 — Eyer Retinal Camera NM-STD
- K221469 — PATI (Protector Against Tongue Injury)
- K221629 — Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters)
- K221741 — TRAUS Air Dental Handpiece
- K221903 — Delta III Pro
- K223298 — Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
- K223492 — eFOLDi Scooter, Lite
- K230180 — Rosa Knee System
- K230197 — BoneMRI v1.6
- K230201 — Disposable Pre-calibrated Brain Biopsy Needle 2.0
- K230208 — Swoop® Portable MR Imaging System
- K230371 — The Alma Soprano Titanium
- K213348 — BOND MMR Antibody Panel
- K214068 — Quantia IgE
- K222184 — Introducer Sheath Kits
- K222259 — NEONA 1.5T MRI System
- K223537 — FreeStyle Libre 2 System, FreeStyle Libre 3 System
- K223612 — Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)
- K223643 — Verifine® Ease Lancing Device, Verifine® Lancing Device
- K220214 — Painless IPL System - KDT750
- K221861 — FloNavi Endoscopic Fluorescence Imaging System
- DEN210022 — PMD-200
- K213755 — Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system
Data sourced from openFDA. This site is unofficial and independent of the FDA.