FDA 510(k) clearances — page 258
clearances on record, most recent first.
Clearances — page 258
25,701–25,800 of 175,699- K172764 — Keymill
- K172866 — NeuroCap
- K173390 — hipEOS
- K180069 — HDR MRI Lumen Marker
- K180154 — QiF Blood and Fluid Warmer
- K180669 — Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total 1 / DAILIES Total 1 Multifocal
- DEN170028 — Cala ONE
- K170339 — Summit Hip System
- K171821 — 2 Face / Face Evolution
- K171872 — P50 Series Dental Operative Unit and Accessories
- K172633 — INFINITY Total Ankle System
- K172875 — Astral 100/150
- K172923 — Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue
- K172955 — LungVision Tool
- K173201 — UNITY Sacroiliac Joint Fixation System
- K173337 — Intuitive Surgical EndoWrist Vessel Sealer Extend
- K173398 — Xpert Xpress Strep A
- K180037 — Beacon EUS Access System
- K180200 — ESG-300, APU-300, Pressure Reducer, MAPC Probes
- K180433 — ENNOVATE®
- K180548 — 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology
- K162525 — Oniko nail brace
- K173143 — Phasix ST Mesh
- K173321 — StimuQuik 21G x 9cm (3.5) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1) Peripheral Nerve Block Needle
- K173782 — UNiD Patient Specific 3D printed cage
- K180002 — Rampart One Lumbar Interbody Fusion Device
- K180257 — InCore® Lapidus System
- K180379 — RayStation 7
- K180514 — VERITON NM
- K180563 — syngo.plaza
- K180616 — OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens
- K162314 — IMACTIS CT-Navigation system
- K172464 — XD880A Ultrasonic Osteotomy Surgical System
- K172768 — ZOOM
- K173865 — trophon2
- K180030 — TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)
- K180206 — neuromate Gen III
- K180222 — Reaxon Plus
- K180225 — GSI Viewer with GSI Fat Option
- K180252 — Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank
- K180277 — Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter
- K171883 — Sysmex UF-5000 Fully Automated Urine Particle Analyzer
- K171917 — Frova Intubating Introducer
- K172329 — Patient Status Engine
- K172393 — Advisor HD Grid Mapping Catheter, Sensor Enabled
- K172396 — EnSite Velocity Cardiac Mapping System v5.2
- K172699 — Agile Nail
- K173519 — 3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-reader
- K173715 — AlertWatch:OB
- K173842 — da Vinci Xi Surgical System, da Vinci X Surgical System
- K180090 — Cure Lumbar Plate System
- K180499 — Reprocessed LigaSure Maryland Jaw Sealer/Divider
- DEN170010 — LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay
- DEN170081 — MALDI Biotyper CA System
- K171443 — Etherea MX
- K172244 — EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern
- K172252 — EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern
- K172511 — Hickman TriFusion Catheter
- K173258 — Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy
- K173855 — Sharpsite AC Rigid Endsocope
- K173900 — Arthrex Univers Revers Modular Glenoid System
- K173902 — Neodent Implant System GM Line
- K173962 — Viamo c100 TUS-VC100 Diagnostic Ultrasound System
- K180140 — ProFlex Laser Fibers
- K180161 — Viz CTP
- K180219 — JO H2O Flavored Personal Lubricants
- K180304 — Geri Embryo Incubator and Geri Dish
- K180322 — Si-Hy (olifilcon B) color silicone hydrogel soft contact lens
- K180451 — Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider
- K180618 — PICO Single Use Negative Pressure Wound Therapy System
- K180750 — World Knee System
- K180753 — SafetyFix EasyOut System
- K180765 — Televere Podiatry X-Ray System HF
- K180782 — Aria
- K171720 — encevis
- K172154 — Isolette 8000 plus
- K172167 — Zenith Flex System
- K172306 — SuperSlyde Personal Lubricant
- K172365 — Panoramic Oxygen Mask (POM)
- K172416 — Synermed Opiate Enzyme Immunoassay
- K172427 — AViTA Radar Thermo NT16 Series IR Thermometer
- K172477 — iSchemaView RAPID
- K172478 — TENS device-EmeTerm, CinvStop
- K172588 — Balloon Catheter and Balloon Ureteral Dilator Set
- K172598 — Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE
- K172887 — XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV)
- K172919 — EV-804 OTC Pain Relief TENS
- K173472 — MySpine Pedicle Screw Placement Guides MC and Drill Pilot Instruments
- K173757 — VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set
- K180007 — 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
- K180102 — Embozene Color-Advanced Microspheres
- K180336 — syngo.MR Applications
- K180576 — Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select)
- K180684 — CoaguChek XS Plus System
- K180693 — CoaguChek XS Pro System
- K180731 — Ultramatrix EUS Balloon
- K180873 — Medtronic Model 53401 External Pulse Generator (EPG)
- K172880 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor
- K172947 — HALF DOME Posterior Lumbar Interbody System
- K173432 — ENZA-A Titanium ALIF
Data sourced from openFDA. This site is unofficial and independent of the FDA.