FDA 510(k) clearances — page 201
clearances on record, most recent first.
Clearances — page 201
20,001–20,100 of 175,699- K193591 — ARC 400
- K200010 — FilmArray BCID2 Control Panel M416
- K200251 — Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System
- K200319 — HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable
- K200552 — EVOS Lumbar Interbody System
- K200696 — FIREBIRD SI Fusion System
- K191065 — Venus VivaTM
- K191762 — Magnetic Surgical System
- K192228 — CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant
- K192658 — Manual Wheelchair
- K192676 — Introcan Safety 2 IV Catheter 18-24 gauge
- K192988 — Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use
- K193580 — VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left
- K200119 — LOGIQ E10s
- K200188 — DSI Dental Implant System
- K200524 — SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GO
- K200622 — Focus 43C detector, TRIMAX 43C detector
- K183086 — da Vinci X and Xi Surgical System
- K191860 — Sterile Powder-Free Synthetic Rubber Surgeons Glove with Low Dermatitis Potential
- K191868 — iCEWav Neuromonitoring Platform
- K192413 — SiteSeal Femoral Compression Device
- K192818 — Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System
- K193054 — Sectra Digital Pathology Module
- K193087 — Rapid ICH
- K193524 — SI-BONE iFuse Implant System®
- K200278 — CytoCore
- K200281 — The Gecko Spinal System
- K200455 — Trigger Switch and Cord
- K200556 — AquaFlate Pre-Filled Sterile Water Syringe 10mL
- K200741 — Tablo Hemodialysis System
- K173590 — System 83 Plus Washer/Disinfector
- K192490 — Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch
- K192640 — Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump
- K193144 — T-Line Hernia Mesh
- K193487 — Agilon Strip
- K193541 — NuVasive Cohere Thoracolumbar Interbody System
- K200040 — Universal Base Conical Connection (CC)
- K192039 — Torc Body
- K200494 — CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES
- K200499 — QuickDraw Venous Cannula
- K192852 — MRI ECG Patient Cable
- K190091 — Diapaste
- K191401 — PregSense
- K191900 — Single Use Grasping Forceps
- K191912 — BiWaze Cough
- K192056 — JJ Series Container System
- K192240 — RAPIDPoint 500e Blood Gas System
- K192389 — TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)
- K193052 — HBP6 Settable, Resorbable Hemostatic Bone Paste
- K193200 — uMR Omega
- K193656 — SkyPulse
- K200140 — Silhouette Instalift
- K200294 — GrandioSO Light Flow
- K200482 — StimRouter Neuromodulation System
- K200548 — CUBEScan BioCon-1100
- K191558 — Konan Specular Microscope XVII
- K191749 — TIGR Matrix Surgical Mesh, TIGR Surgical Mesh
- K191830 — gammaCore Sapphire
- K192724 — Propeller Sensor for Symbicort
- K192732 — BodyGuardian Remote Monitoring System
- K192886 — OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip
- K192951 — Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun
- K192987 — Aina HbA1c Monitoring System 2
- K193053 — Tina-quant Hemoglobin A1cDx Gen.3
- K193108 — Bonecam Suture Anchor
- K193136 — Stryker Customized Mandible Recon Plate Kit
- K193143 — Stryker Facial iD Plating System
- K193518 — KOSMOS
- K193633 — APTUS® Ankle Trauma System 2.8/3.5
- K193639 — APTUS® Foot 2.8-3.5 System
- K193652 — AbClose - Port Site Closure Device
- K200108 — GEO 1st MTP Joint Arthrodesis Plating System
- K200456 — Becker External Drainage and Monitoring System
- K192008 — LaserShot M, NaviLase
- K192144 — STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device
- K192284 — DiaFil Flow
- K192437 — Arterys MICA
- K192534 — CrossBay Endometrial Tissue Sampler (ETS)
- K192854 — MammoScreen
- K192967 — Medacta Shoulder System
- K193078 — MIS CONNECT Conical Connection System
- K193311 — Aluna
- K193328 — IPL + Diode Laser Machine
- K193593 — NuVasive 3DP Interfixated ALIF System
- K193614 — FINE Osteotomy around the knee
- K193615 — NorthStar OCT Spinal System
- K193619 — Cry-Ac®, Cry-Ac-3®, Cry-Baby
- K193629 — Disposable NIBP Cuff
- K193661 — LightWalker Laser System Family
- K193667 — Shapiro MD model laser 272
- K200241 — TempSure System
- K200515 — syngo.CT Cardiac Planning
- K193100 — RESPONSE Spine System, RESPONSE 4.5/5.0 Spine System, RESPONSE 5.5/6.0 Spine System
- K193145 — Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch
- K193335 — Sherlock
- K193579 — PlasmaBlade X 3.0S LIGHT
- K200209 — Persona Personalized Knee System
- K200224 — SEA-LINK Anterior Cervical Plate System
- K200337 — FloPatch (FP120)
- K191716 — Somryst
Data sourced from openFDA. This site is unofficial and independent of the FDA.