FDA 510(k) clearances — page 129
clearances on record, most recent first.
Clearances — page 129
12,801–12,900 of 176,479- K221762 — BoneMRI v1.4
- K222364 — Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA)
- K222628 — Life Spine ALIF Buttress Plate System
- K211830 — LifeSPARC System
- K212612 — Omnia Medical TiBrid-SC
- K212700 — Dyflex-II
- K220535 — Cardio10
- K221558 — ALPHALOK Plating System
- K221722 — Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)
- K221744 — STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
- K222055 — Disposable Sterile Lancet
- K222175 — Bloomi Delight Oil-Based Personal Lubricant
- K222309 — Gamma4 System
- K222488 — Everyway Analog OTC TENS
- K222564 — Treace Medical Concepts (TMC) Hammertoe Fixation System
- K222915 — Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS
- K223199 — 2.1 x 255mm Drill, 22mm Stop
- K210980 — Smith & Nephew Intramedullary Nail Systems
- K213217 — Disposable hemoclip
- K220326 — PosiSep X BAM Hemostat Dressing/Intranasal Splint
- K221578 — Hexanium ACIF
- K221655 — Multiflex Steerable Sheath
- K222428 — Syngo Dynamics (Version VA40F)
- K222480 — Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)
- K222490 — HBL Blade Assembly
- K222520 — Zirconia Block
- K222529 — Surgical Face Mask
- K222540 — uPMR 790
- K222749 — High Fluid-Resistant Surgical and Procedure Mask
- K213981 — Nitrile Examination Gloves
- K212164 — Mapping Suction Probe
- K220983 — ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System
- K222225 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)
- K211934 — APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg
- K211954 — Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid
- K213294 — Dermal Cooling System
- K220230 — AMSure Enteral Feeding Pump
- K220360 — Tandry CMF Plate System
- K220408 — AVIEW RT ACS
- K220562 — TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment
- K220794 — 10PL
- K220957 — FUJIFILM Endoscope Model EB-710P
- K221139 — Bodygard SFS Surgical Gown Level 4
- K221183 — AEYE-DS
- K221225 — Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer
- K221391 — WOLF Thrombectomy SmartClaw Catheter
- K221677 — Synapse 3D Base Tools v6.6
- K221678 — SprintRay High Impact Denture Base
- K222061 — Dental LT Clear V2 Resin
- K222067 — SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set
- K222317 — Catalyst EA Convertible Stemmed Shoulder
- K222475 — SNOR LOCK
- K222504 — H1
- K222551 — Humask Pro Vision, Humask Pro Vision 3000
- K222667 — Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx
- K223171 — AquaPulse® Irrigation Tubing
- K223185 — BreathID® Smart System
- K223198 — BD Intraosseous Vascular Access System EMS Powered Driver (D001003)
- DEN200044 — Eonis SCID-SMA Kit
- K203035 — Eonis SCID-SMA kit
- K220334 — MONET Anterior Cervical Plate System
- K221539 — GammaTile
- K221855 — Universal CMF System
- K222162 — Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)
- K222166 — SOLIX
- K222198 — Exo Iris (El2001)
- K222497 — Zaga Zygomatic System
- K222754 — ViewMate Multi Ultrasound System
- K223132 — Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)
- K203812 — Oxyfit Pulse Oximeter
- K210346 — Sysmex XW-100 Automated Hematology Analyzer
- K221552 — EFAI ChestSuite XR Pneumothorax Assessment System
- K222132 — Hisense LCD monitor HMD2G21S, HMD3G21S
- K222304 — Sonata Transcervical Fibroid Ablation System 2.2
- K222734 — Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing
- K223178 — SelectSite C304 Deflectable Catheter System, C315 Delivery System
- K212317 — Eclipse MINI Model 98900
- K220346 — Lotus Prophy Angle
- K220489 — Durex Patronus CloseFit, Durex Patronus Regular
- K220874 — Smooth Drive contra angle and straight handpieces
- K221833 — HemoSphere Advanced Monitor, HemoSphere ClearSight Module
- K222679 — Vericor Support Catheter
- K222732 — WaveForm A Interbody System
- K222741 — DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)
- K222800 — Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A)
- K222873 — Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system
- K222898 — SafeSource Direct Blue Powder-Free Nitrile Exam Gloves
- K222936 — Humeris® 135 Shoulder System
- K223127 — HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable
- K202755 — Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack
- K201256 — Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge
- K212764 — Medwell Technology Ltd Syringes, various sizes
- K213108 — Humerus & Ulna System
- K220421 — BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System
- K220833 — Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL
- K221007 — cobas HCV
- K221086 — CryoRobot Select System
- K221162 — UniVy OsteoVy Cervical IBF System
- K221610 — Nextra CH Cannulated Hammertoe System
- K221659 — Luminopia One
Data sourced from openFDA. This site is unofficial and independent of the FDA.