FDA 510(k) clearances — page 195
clearances on record, most recent first.
Clearances — page 195
19,401–19,500 of 175,699- K193620 — OptoMonitor 3
- K200283 — Medussa-PL Cage
- K200297 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor
- K200424 — Giotto Class (Models - 3000X-YY and 4000X-YY)
- K200481 — Andorate Biopsy Valve, Andorate Biopsy Irrigator
- K200727 — TENS and Muscle Stimulator
- K200892 — Harvey(R) Surgical Assistant
- K201311 — PF4 IgG assay
- K201327 — NavLock Trackers
- K201337 — InPen System
- K201347 — DePuy ATTUNE Total Knee System
- K192478 — LT Antibacterial Alginate with Silver Dressing
- K192747 — Yxoss CBR®
- K193253 — Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503
- K193290 — AI-Rad Companion Brain MR
- K193399 — Miru 1day UpSide (midafilcon A)
- K200389 — INOmax DSIR Plus
- K200875 — ArtiSential Laparoscopic Instruments - Electrodes
- K200921 — qER
- K201029 — Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.