FDA 510(k) clearances — page 203
clearances on record, most recent first.
Clearances — page 203
20,201–20,300 of 176,479- K201220 — Aerus Medical Guardian,model F170A
- K201319 — Medline UNITE Jones Fracture Screw System
- K201322 — Entuit Nasal Jejunal Feeding Tube
- K190408 — Spinal Fixation System
- K192542 — Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde
- K193288 — Koya Ripple
- K193540 — TRUMATCH Personalized Solutions
- K200467 — Control-IQ Technology
- K201023 — iTotal® Identity Posterior Stabilized Knee Replacement System
- DEN200026 — EndeavorRx
- K193376 — Visalis V500, Visalis S500
- K200087 — F3D Cervical Stand-Alone Interbody Fusion System
- K200508 — Pump In Style
- K200899 — Quantib AI Node
- K201116 — Abiomed 23 Fr Sheath
- K201313 — CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ)
- K201481 — Centurion POCT System
- K200446 — STERIS Patient Warming System
- K192201 — Electrical Stimulator System
- K193166 — MAMMOMAT Revelation
- K193371 — FreeStyle Libre 2 Flash Glucose Monitoring System
- K193379 — Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe
- K200521 — Full Automatic(NIBP) Blood Pressure Monitor
- K200683 — INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir
- K200756 — Kubtec Mozart Supra
- K200909 — Hemo Control (optional Add Pack Hemo Control DM)
- K201022 — REAL INTELLIGENCE CORI (CORI)
- K201288 — ExpanSure Large Access Transseptal Dilator
- K192630 — uWS-MI
- K193415 — physIQ Heart Rhythm and Respiration Module
- K200356 — MEDO ARIA
- K200616 — E>EyeC
- K200685 — RIGEL 3DR Anterior Cervical Interbody Fusion System
- K200980 — Auto 3D Bladder Volume Tool
- K200998 — Versana Active
- K201007 — In-Ka Ureteral Balloon Dilatation Catheter
- K201117 — Gold Anchor
- K201271 — Benchmark BMX96 Access System
- K192003 — Auxein Nailing System
- K193094 — Naviswiss Hip Navigation System
- K200131 — BruxZir Steel
- K200487 — RayCare 3.1
- K200879 — SeaSpine Meridian System, SeaSpine Regatta Lateral System
- K200972 — Hemospray Endoscopic Hemostat
- K200976 — SR-8230, SR-8230S Portable X-ray Unit
- K201247 — Intraoral Sensor
- K201255 — TSolution® One Total Knee Application
- K181813 — ImmersiveView Surgical Plan (IVSP®)
- K192033 — Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip
- K193075 — Osteo3 ZP Putty
- K200042 — CO2 Laser System
- K200753 — IBS Implant System II
- K200786 — Venus Epileve
- K201063 — DANNIK Disposable Monopolar Laparoscopic Instrument
- K193067 — The INBONE Total Ankle System, the INFINITY Total Ankle System and the INVISION Total Ankle Revision System
- K193354 — Air Compression Therapy Device
- K200015 — ePM Series Patient monitors
- K200967 — mCare(R) Powder Free Nitrile Orange Examination Gloves
- K191461 — Exofin Fusion Skin Closure System
- K191491 — EZ-Cover
- K192550 — 3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H
- K192952 — Spire Health Remote Patient Monitoring System
- K192957 — VivaChek Blood Glucose and B-Ketone Monitoring System
- K193003 — NemoCast
- K193150 — Latex Examination Powder Free Glove, Aloe Vera
- K200107 — epoc Blood Analysis System
- K200398 — AxSOS 3 AF System and AxSOS 3 Ti System
- K200441 — UroLift Advanced Tissue Control (ATC) System
- K200615 — Signature ONE System
- K200952 — Hummingbird Tympanostomy Tube System
- K201212 — Voyant Open Fusion Device
- K193555 — Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate
- K200057 — bioli lOL Delivery System
- K200104 — Oxylight
- K200227 — Journey II XR Knee Instrument
- K200277 — Livongo Blood Glucose Monitoring System (BG1000)
- K200883 — CarboClear® Cervical Plate System
- K200949 — HEALIX ADVANCE Anchor with DYNATAPE Suture
- K201214 — t:slim X2 Insulin Pump with Interoperable Technology
- K201223 — LZI Tramadol Enzyme Immunoassay
- K192310 — Flap Fixator, Burr Hole Cover
- K193021 — Vantage Orian 1.5T, MRT-1550, V6.0
- K193226 — AltiVate Anatomic Canal-Sparing (CS) Shoulder
- K200268 — Halo Single-Loop Snare Kit
- K200459 — pREBOA-PRO Catheter
- K200506 — DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader
- K200514 — Cardioblate Gemini-s Surgical Ablation Device
- K200602 — Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant
- K200721 — Agilis HisPro Steerable Catheter With Electrodes
- K200907 — Thales 3D Mr Scanner
- K200929 — Hair Growth System
- K200974 — QLAB Advanced Quantification Software
- K201175 — StealthStation Cranial Software v1.3.0
- K192779 — Bunny Wax Personal Lubricant
- K193307 — HIP7
- K193438 — DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)
- K200089 — F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model
- K200322 — Altus Spine Pedicle Screw System
- K200528 — Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism
- K200532 — StarPore
Data sourced from openFDA. This site is unofficial and independent of the FDA.