FDA 510(k) clearances — page 267
clearances on record, most recent first.
Clearances — page 267
26,601–26,700 of 176,542- 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
- K173615 — Stryker Universal Select Sterilization Tray System
- K173661 — Wingman 35 Crossing Catheter
- K173964 — OVOMotion Shoulder Arthroplasty System
- K180081 — RAILWAY Sheathless Access System
- K180836 — Genistrong
- K180851 — VERTEX Reconstruction System
- K172288 — Fusion OMNI Sphincterotome
- K172610 — THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S
- K172735 — WR19 System
- K173317 — DiLumen C2; DiLumen Tool Mount
- K173614 — Penumbra Coil 400, Ruby Coil System, POD System
- K173816 — NM/CT 850, NM/CT 860
- K180078 — Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System
- K180146 — KARL STORZ ICG Imaging System
- K180353 — Diode laser hair removal device
- K180416 — ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System
- K180458 — FOCUS Pedicle Screw System
- K180588 — FAST1 Intraosseous Infusion System; FASTResponder Sternal Intraosseous Device
- K180723 — PreludeSYNC DISTAL Radial Compression System
- K180914 — Aesculap Slim Clip Applier
- K171603 — Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set
- K172727 — Hemoclip
- K173226 — CardiMax Electrocardiograph
- K173726 — ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut
- K173935 — Mediant Anterior Cervical Plating System
- K180096 — GDT-1000 System
- K180126 — SOZO
- K162499 — Best Instruminal Applicator
- K170463 — KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System
- K170761 — LIGHTSonic BUBM
- K170901 — ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400
- K171326 — Piezosurgery White
- K171562 — Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono
- K172143 — uMI 780 PET/CT System
- K172930 — mCare Powder-free Blue Nitrile Examination Gloves
- K173103 — Pivet and Soft-Pass Embryo Transfer Catheter Sets
- K173371 — VisuMax Femtosecond Laser
- K173606 — SeaSpine Vu aPOD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu aPOD Prime Intervertebral Body Fusion Device
- K173632 — SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO
- K173692 — D-Actor 200 Vibration Massage System
- K173934 — Reza Band, Reflux Band
- K180305 — Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)
- K180408 — U60 Diagnostic Ultrasound System
- K180667 — SmartGrid
- K180699 — Voyant Open Fusion Device
- K180704 — SonoSite iViz Ultrasound System
- K172155 — StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing
- K172201 — Atellica IM Folate Assay
- K172315 — Straub Endovascular System
- K173515 — Admiral Xtreme
- K180549 — ZED Link
- K180567 — C3 Wave System
- K180651 — Uroview FD II
- K180666 — 48CH Head Coil
- K180689 — Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device
- K180795 — JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire
- DEN180001 — IDx-DR
Data sourced from openFDA. This site is unofficial and independent of the FDA.