FDA 510(k) clearances — page 252
clearances on record, most recent first.
Clearances — page 252
25,101–25,200 of 175,699- K180314 — Infrared Thermometer
- K180725 — Aspire Introducer Needle
- K180730 — INVISION Total Ankle Revision System
- K180816 — Ziehm RFD 3D Tracker
- K180963 — ROCCIA ALIF, ROCCIA TLIF
- K180967 — Dental Diode Laser System
- K181523 — Syneron CO2RE System
- K181697 — 16ch Foot/ Ankle SPEEDER
- K172991 — Advanced Dental Applicance
- K173039 — TruMatch CMF Titanium 3D Printed Implant
- K173274 — Ceevra Reveal 2.0
- K180289 — 3D Bolus Software
- K180697 — Pseudo-Patient
- K180900 — LED Light Therapy Device
- K180970 — Disposable guides KDNG00
- K181201 — Synermed ISE Reagents
- K181244 — Zavation Cervical Plate System
- K181246 — Zavation IBF System
- K181572 — Workflow Box
- K181574 — Uscan
- K181700 — HardyDisk AST Plazomicin 30ug (PLZ30)
- K173562 — Straumann Jason Membrane
- K180798 — Prime Acetabular Cup System
- K180923 — Personal Lubricating Jelly
- K180930 — EMPOWR VVC TIBIAL INSERT
- K181261 — Curiteva Cervical Interbody Fusion System
- K181522 — PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope
- K181547 — FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)
- K172971 — BMLS16-1
- K173766 — PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs
- K172694 — Sterile Disposable Syringes
- K173019 — GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar
- K173659 — Howell D.A.S.H Extraction Balloon with Multiple Sizing
- K173776 — BIOLOX delta Option and Extra-long Heads
- K173927 — Elecsys BRAHMS PCT
- K173970 — Materialise PKA Guide System
- K180515 — GammaTile
- K180590 — Tyber Medical PT Interbody Spacer System
- K180755 — Vail ALIF Buttress Plate System
- K180868 — Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set
- K181092 — CHROMID CARBA agar (CARB)
- K181139 — OLYMPIC Posterior Spinal Fixation System
- K181327 — InPen Dose Calculator
- K181350 — ASTRA-OCT Spine System
- K181499 — DRI Cocaine Metabolite Assay
- K181509 — Endorate Valve Sets
- K161085 — Nitrile Patient Examination Powder Free Glove, Textured, Black
- K172778 — CheckMyHeart Plus
- K173277 — ASAHI PTCA Guide Wire ASAHI SION black
- K173359 — Fractional CO2 Surgical Laser System
- K173721 — SureForm 60 and SureForm 60 Reloads
- K180018 — Disposable Hot Biopsy Forceps
- K181044 — 400um Perforator and Accessory Vein Ablation Kit
- K181175 — 12F Tri-Flow Triple Lumen Catheter
- K181493 — FilmArray Blood Culture Identification (BCID) Panel
- K180705 — Riptide Aspiration System React 68 Catheter
- K180715 — React 68 Catheter
- K172952 — Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit
- K173679 — PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes
- K180367 — Ureterorenoscope System
- K180936 — ETEST Telavancin (TLA) (0.002-32 ug/mL)
- K181193 — PeriView FLEX
- K181526 — XRpad2 4343 HWC-M Flat Panel Detector
- K173276 — Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP
- K173864 — Peekplus® Interbody Fusion Device
- K173868 — Serenity Body Position Sensor, Serenity RIP Sensors
- K180910 — ULTRAPRO Mesh and ULTRAPRO ADVANCED
- K171414 — qEEG-Pro
- K171197 — Zuga Dental Implant System
- K172556 — TubeClear System
- K173164 — Ecolab POU Water Filter
- K173815 — Allergan Botox Needle Electrode
- K180021 — Proton Positioing and Immobilization Devices
- K180038 — NuVasive Pulse System
- K180134 — Ensizor Monopolar Endoscopic Scissors
- K180389 — Venera 508 Deep Vein Thrombosis (DVT) Prevention System
- K180481 — Servator B SALF Solution
- K181068 — CREO® Stabilization System, REVERE® Stabilization System
- K181232 — Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia
- K181410 — MotoCLIP/HiMAX Implant System
- K172457 — Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM
- K173116 — KJ ZIRCONIA Implant System
- K173162 — GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide
- K180562 — TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT
- K180583 — LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD
- K180729 — FaSet Fixation System
- K180829 — PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh
- K180865 — ZMI Self-Adhesive Electrodes
- K180921 — Sapphire II PRO Balloon Dilatation Catheter
- K180993 — Beacon Advanced CO2 Laser System
- K181121 — Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro
- K181144 — Angled Tip Ureteral Catheter
- K181203 — Juliet Ti
- K181404 — Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator
- K181474 — ArtiClip LAA Exclusion System
- K180364 — HD LifeSciences Cervical IBFD System
- K180454 — Shockwave Medical Intravascular Lithotripsy (IVL) System
- K180646 — Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
- K180720 — Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel
- K180858 — CALLISTO eye
Data sourced from openFDA. This site is unofficial and independent of the FDA.