FDA 510(k) clearances — page 209
clearances on record, most recent first.
Clearances — page 209
20,801–20,900 of 176,479- 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
- K191763 — MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC
- K191788 — CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System
- K191909 — HepaShield Bacterial Viral Breathing System Filter
- K193453 — TruDi Probe
- K193479 — Sternal Cable System
- K200043 — Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws +1 more
- K200436 — Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit
- K200485 — RadiForce RX1270, RadiForce RX1270-AR
- K200543 — NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System
- K200493 — Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover
- K191612 — Encision AEM Monopolar Laparoscopic Instruments and Accessories
- K191657 — Bioland Blood Glucose Monitoring System
- K191680 — AZUR Vascular Plug
- K191735 — CPT Hip System
- K191838 — Clearform Aligners
- K192300 — EnlightenVue Microendoscopy System
- K192510 — DIAFIL & DIAFIL Capsule
- K192897 — icotec Cervical Cage
- K193089 — MULTIX Impact
- K193121 — GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims
Data sourced from openFDA. This site is unofficial and independent of the FDA.