FDA 510(k) clearances — page 120
clearances on record, most recent first.
Clearances — page 120
11,901–12,000 of 175,620- K222496 — Electromed SmartVest Airway Clearance System
- K222535 — OCS Lung Donor Flush Set
- K222539 — Facet Blood Lancets
- K222701 — MANTA Laser
- K222816 — Opulent TiNbN Coated Knee
- K222903 — Tailored-H Cervical Stand Alone System
- K223003 — Banded Face Mask
- K223124 — EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG
- K223246 — Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense
- K223293 — CONTOUR® NEXT GEN Blood Glucose Monitoring System
- K211265 — TFX-LT2000 Therapy Light
- K212910 — Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece
- K213042 — Supra Non-Stick Bipolar Forceps
- K213295 — C.C. LIFE 21
- K220042 — Dentca Base Premium, Dentca Base Hi-Impact
- K220558 — Blood Administration Sets
- K220739 — Disposable Urine Collection Tube
- K220820 — Parky App
- K220905 — xvision Spine System
- K221178 — Disposable Insulin Pen Needle
- K221281 — Multitom Rax
- K221479 — Persona Personalized Knee System
- K221593 — Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus
- K222109 — Accure Laser
- K222208 — Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D
- K222476 — OmegaAI Image Viewer
- K222518 — FX Contra
- K222598 — IPL Hair Removal Device
- K222673 — Alexandrite and Nd:YAG Laser models CANLASE and TORLASE
- K222973 — IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody Sytem
- K223227 — MAVEN Patient-Specific Instrumentation
- K223267 — SKR 3000
- K223278 — easy Claire
- K203528 — KNH Surgical Face Mask
- K212812 — Surgical Gown
- K220302 — Disposable surgical face mask
- K220465 — PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10
- K220533 — Endoscopy Oxygen Mask
- K220635 — Heater-Cooler System 3T
- K220841 — PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)
- K221094 — OmniTaper EV Dental Implants, DS Implants abutments with EV connection
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.