FDA 510(k) clearances — page 112
clearances on record, most recent first.
Clearances — page 112
11,101–11,200 of 175,620- 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
- K220276 — Infrared Thermometer TET-351
- K221043 — Doctor Tecar Plus, Doctor Tecar Smart
- K221483 — FlowSaver Blood Return System
- K221513 — Equashield Closed System Transfer Device
- K221645 — PROstep(TM) MIS 5mm Chamfer Screw System
- K222226 — EON
- K222588 — Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1
- K222695 — troCarWash System
- K222971 — ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Fixation Device; ULTRABUTTON TIB MEDIUM Adjustable Fixation Device; ULTRABUTTON TIB LARGE Adjustable Fixation Device
- K222977 — DSPS-Prominent Masks; DSPS-Prominent Baseplate, MR; CouchStrip
- K223466 — Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS101
- K223497 — Spectrum Saliva Collection Device
- K223545 — APRO 70 Catheter and Alembic Aspiration Tubing
- K223798 — Glidewell TuffSplint Appliance Resin
- K223820 — EzDent-i / E2 / Prora View/ Smart M Viewer
- K223897 — Excipio LV Thrombectomy Device
- K212194 — Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System
- K213844 — Surgical Gown
- K220698 — Bambino 3, S3 and S3 Swing, U3 and U3 Light, X
- K221784 — Single-use Video Pancreaticobiliary Scope, PB Digital Controller
- K222065 — Passeo-35 Xeo Peripheral Dilatation Catheter
- K222622 — Disposable Infusion Bag for Parenteral Nutrition
- K222755 — uMR 680
- K223028 — uCT ATLAS Astound with uWS-CT-Dual Energy Analysis
- K223056 — JAWS Nitinol Staple System
- K223327 — Sterile Aesthetic Cannula and Hypodermic Needle
- K223477 — PMMA Blocks for Dental Use
- K223478 — VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin
- K223524 — IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03
- K223733 — CARTO® 3 EP Navigation System with CARTOSOUND 4D Version 7.4
- K223766 — NUVISION NAV Ultrasound Catheter
- K223770 — Sonopet 1Q 3 7cm 1Q Large
- K223832 — Vivid S60N, Vivid S70N
- K230118 — Bony Trauma Extremity System (BTES) Screw Range, NX Nail
- K213669 — LIGHTSCALPEL LS-4020
- K221523 — Tanning Lamp
- K221874 — Altis Single Incision Sling System
- K222271 — Verisafe Safety sterile needles
- K222389 — ZEUS System
- K222869 — Arm Blood Pressure Monitor
- K223022 — SC HONKYTONK PTCA Balloon Dilatation Catheter
- K223046 — Xpert® FII & FV
- K223407 — Versana Essential
- K223815 — ONE DROP Lancing Device
- K223891 — Cobra Catheter System
- K230131 — ReShape Calibration Tubes
- K230175 — Digital Radiography CXDI-CS01
- K213757 — Endocem MTA Premixed Regular
- K221468 — Citregen Tendon Interference Screw (TIS), Citrelock Tendon Fixation Device, Citrespline and Citrelock ACL Implants
- K221490 — Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT Vertebral Body Replacement System, VLIFT-s Vertebral Body Replacement System, Ascential IBD PEEKc Spacer, Aero-AL Lumbar Cage System, Aero-LL Lumbar Cage System, Aero-C Cervical Cage System, AVS Aria PEEK Spacer, AVS Anchor-C Cervical Cage System, AVS Anchor-L Spacer
- K221527 — StitchKit
- K221672 — Creo Electrosurgical System with NP1 Instrument
- K223174 — X-Pac Expandable LLIF Cage System
- K223225 — 8ch T/R Knee Coil
- K212635 — Sofjec
- K213030 — Curiteva Porous PEEK Cervical Interbody Fusion System
- K221875 — Sterilization Pouch and Roll
- K222327 — Bloomlife MFM-Pro
- K222341 — Arrow 0.2 Micron Flat Filter, GVS
Data sourced from openFDA. This site is unofficial and independent of the FDA.