FDA 510(k) clearances — page 266
clearances on record, most recent first.
Clearances — page 266
26,501–26,600 of 176,542- K172777 — Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7
- K172980 — Micropuncture Pedal Access Set
- K173540 — Brainsway Deep (DTMS) System
- K180019 — CAAS Workstation
- K180071 — STYLO Interbody Fusion Device
- K180162 — VivaScope System
- K180214 — Repris Bladder Injection System
- K180939 — Indigo Aspiration System - Modified 110 Aspiration Tubing
- K181001 — Medtronic Confida Brecker Guidewire
- K172409 — Lite
- K172864 — Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
- K173653 — Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit
- K173807 — Accu O2 Oxygen Analyzer
- K173825 — MC 300R* Nebulizer
- K173861 — Drug Relief
- K173946 — ADAPT for Gamma3
- K180028 — Cook 810 Set, Desilets-Hoffman Introducer Set
- K180264 — Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
- K180352 — 7D Surgical System
- K180599 — Venue
- K180796 — Spineology Navigation Instruments
- K172412 — BacterioScan 216Dx System
- K172554 — LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing
- K172555 — SAPPHIRE, ELEVARE SAPPHIRE
- K172656 — BiliLux
- K172959 — PeraServer and PeraTrend
- K173035 — Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets
- K173300 — ViaTherm BOOST
- K173718 — Liberty Cycler Set
- K180848 — AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches
- K171678 — Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable
- K172636 — VitaMESH Macroporous PP Surgical Mesh
- K172726 — EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D
- K173304 — Finessis Intense Polyisoprene Surgical Glove
- K180307 — Mazor X
- K180636 — ExactVu High Resolution Micro-Ultrasound System
- K180696 — Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal (Tested for use with Chemotherapy Drugs)
- K171151 — ACRON TLIF System
- K172166 — OLYMPIC Navigated Instruments
- K172258 — Novasight Hybrid System
- K172460 — ADHEAR System
- K172720 — TRACOE silcosoft Tracheostomy Tube
- K172747 — HYALURONIC ACID TOPICAL WOUND CREAM
- 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 +1 more
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.