FDA 510(k) clearances — page 286
clearances on record, most recent first.
Clearances — page 286
28,501–28,600 of 176,542- K170013 — Eztetic BellaTek Encode Healing Abutments
- K170118 — Scanostics UTI Check Application Test System
- K170641 — da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes
- K170705 — ARIX Wrist System
- K170879 — IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories
- K171184 — Persyst Mobile App
- K171232 — PeriView FLEX
- K171804 — Zap-X Radiosurgery System
- K171829 — EndoNaut
- K171852 — DARCO Locking Bone Plate System
- K171891 — ZS3 Ultrasound System, z.one pro Ultrasound System
- K172082 — S60 Series Digital Color Doppler Ultrasound System
- K172219 — Mako Total Knee Application
- K172486 — Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 100mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 250mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 500mL bottle
- K172501 — iNSitu Total Hip System
- K163283 — HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010
- K163614 — PENTAX Medical ED34-i10T, Video Duodenoscope
- K170292 — Tri-Ex Extraction Balloon With Multiple Sizing
- K171541 — Powder Free Nitrile Examination Gloves (Orange)
- K171822 — NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352)
- K171876 — Ceramill Zolid HT+ white
- K172247 — Magic3 Go Intermittent Urinary Catheter
- K172279 — PMT Posterior Fixation System
- K172314 — Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)
- K172521 — PICO Single Use Negative Pressure Wound Therapy System
- K172566 — Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
- K163135 — Finger Pulse Oximeter
- K163518 — Digital Thermometer
- K163611 — Pain Therapy Device
- K170002 — Medline Blood Collection Set
- K171632 — da Vinci Xi Surgical System
- K171964 — LigaMetrics Suture Anchors
- K172196 — ECOM Cardiac Output Monitoring System
- K172199 — ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium
- K172299 — Accordion Piccolo Stone Management Device
- K162828 — Winback Back 3SE
- K163422 — Shanghai Sanyou PEEK Cage System
- K163433 — VITROS Chemistry Products GLU Slides
- K163664 — Health-e-Connect System with IDA
- K170179 — LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity
- K170286 — Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan (hioxifilcon A) Daily Wear Soft (Hydrophilic) Contact Lens for PRESBYOPIA
- K172587 — Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers
- K170640 — Endoscope Sterilization Tray
- K172506 — BD Cathena Safety IV Catheter
- K162482 — A.B. DENTAL DEVICES Dental Implants System
- K163590 — Psychemedics Microplate EIA for Benzodiazepines in Hair
- K163666 — neuro inspire
- K170231 — iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5)
- K170417 — Glidewire GT
- K170527 — Phoenix Clinical ICON
- K170838 — Medentika CAD/CAM TiBases
- K171123 — Leksell Vantage Stereotactic System
- K171176 — M-CATH Microcatheter
- K171446 — Cefaly Acute
- K171519 — FLXfit
- K171652 — Fresenius Liberty Select Cycler
- K171686 — Choice Spine Hawkeye Vertebral Body Replacement (VBR) System
- K171785 — WowGoHealth Blood Glucose Monitoring System
- K171840 — Stryker Consolidated Operating Room Equipment (CORE) 2 Console
- K172064 — Ti-Diagon Oblique TLIF
- K172150 — Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL)
- K172356 — BladderScan Prime PLUS System
- K172519 — PICO Single Use Negative Pressure Wound Therapy System
- K172522 — Mazor X
- DEN160018 — reSet
- K163148 — BePOD® Foot Screws
- K163209 — Fiagon Navigation System
- K163556 — MediClear PreOp
- K163627 — Shotel Ankle Arthrodesis Nail System
- K170168 — Masimo Rad-97 and Accessories
- K170323 — Entuit Start Initial Placement Gastrostomy Set
- K170378 — AirLife Adult Heated Wire BiPAP/NIV Circuit
- K170937 — VIPER PRIME navigated inserter
- K171378 — Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs
- K171832 — Range/Denali/Mesa Spinal System
- K171953 — Bard Mission Disposable Core Biopsy Instrument
- K172120 — Veress Needle
- K172385 — Clarius Ultrasound System
- K172479 — Amsel Occluder Device
- K172481 — IntelliCart System
- K172513 — 3D Echo
- K163215 — AnemoCheck
- K171051 — HORIZON Therapy System
- K171201 — NeuViz Prime Multi-slice CT Scanner System
- K171359 — Pollogen Legend+ System
- K171664 — Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software
- K172142 — FibroScan 430 Mini+
- K170185 — tremoFlo C-100 Airwave Oscillometry System
- K170409 — PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System
- K170875 — da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments and Accessories
- K171144 — Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel
- K171233 — Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
- K171537 — CAPI 3 Hb A1c
- K171582 — NEO Pedicle Screw System
- K171770 — cobas Cdiff Nucleic acid test for use on the cobas Liat System
- K170275 — Tri Auto ZX2
- K170368 — Sterile NS System
- K170487 — Navina Classic System
- K170596 — TN-Brush
- K170644 — da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm)
Data sourced from openFDA. This site is unofficial and independent of the FDA.