FDA 510(k) clearances — page 210
clearances on record, most recent first.
Clearances — page 210
20,901–21,000 of 175,699- K192130 — Icobrain
- K192152 — DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System
- K192220 — ReliOn Premier Classic Blood Glucose Monitoring System
- K192362 — Aero Blue Performance Surgical Gowns
- K192370 — MEDRAD Stellant FLEX CT Injection System with Certegra Workstation
- K192531 — QyScore Software
- K192554 — decimal3D
- K192569 — Diode Laser Therapy System
- K192627 — Laser Hair Growth Cap
- K192647 — neria guard Infusion Set
- K192829 — Demetra BDEM-01 Dermatoscope
- K193148 — VaPro Plus Pocket, VaPro Plus
- K193162 — EPi-Sense Guided Coagulation System with VisiTrax
- K193170 — Deep Learning Image Reconstruction
- K193173 — CareView 1800Le
- K193194 — CrossTorq 14 Guidewire
- K193202 — EXALT Model D Single-Use Duodenoscope, EXALT Controller
- K193317 — CoreLite X-Ray Specimen Cabinet
- K193344 — Tri-Ex Extraction Balloon with Multiple Sizing
- DEN180056 — GSP Neonatal Creatine Kinase - MM kit
- K182987 — Genesys Spine 3DP Lumbar Interbody System
- K190537 — BIO-C Sealer Ion+
- K190673 — Health Expert Electronic Stimulator
- K190793 — Tablo Hemodialysis System, Tablo Cartridge
- K191163 — Lumax Guiding Catheter
- K192340 — OptoMonitor
- K192505 — HS50/HS60 Diagnostics Ultrasound System
- K192938 — Invictus Spinal Fixation System
- K193133 — Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set
- K193157 — Arthrex 3.9mm Corkscrew Suture Anchor
- K182739 — Endotracheal Tube with Evacuation Lumen
- K190508 — EVO 450 series High Speed Handpieces
- K191086 — Exciplex
- K191618 — SleepTight Mouthpiece STZ
- K191880 — Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter
- K192149 — MIS Dental Implant System
- K192507 — LOSPA II Knee System
- K192571 — NemoScan
- K193123 — FUJIFILM Distal Cap Models 33-40
- K193126 — HI-TORQUE InfilTrac Guide Wire Family
- K193132 — CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream
- K193135 — TSolution One Total Knee Application
- K193167 — NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
- K190239 — Single Use Aspiration Needle
- K192287 — Transpara
- K192319 — HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System
- K192516 — Diode Laser 808nm
- K192533 — Health Line CT CVC
- K192929 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
- K181900 — Dental high speed handpiece, Dental low speed handpiece
- K190968 — CEDIA Benzodiazepine Assay
- K191054 — Southern Implants MAX Implant System
- K191700 — EyeStat
- K191793 — Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System
- K191895 — Straumann Mini Implants
- K192225 — Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses
- K192439 — JETi Peripheral Thrombectomy System
- K192442 — FFRangio
- K192522 — TSV BellaTek Express and BellaTek Flex Abutments
- K192885 — C.T.M. Mobility Scooter HS-268
- K190273 — T3 Platform software
- K192279 — PhantomMSK Trauma
- K183052 — ID-Cap System
- K190382 — Intraocular Pressure Tonometer EASYTON
- K190552 — JJ Implant System
- K190612 — EQUINOX Balloon Dilatation Catheter
- K190656 — Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings
- K191239 — Smart Peak Flow Meter
- K191279 — Disposable SpO2 Sensor
- K191861 — Aurora Surgiscope System
- K192324 — Sheridan Spiral-Flex Endotracheal Tubes
- K192443 — Dextile Anatomical Mesh
- K192521 — Intense Pulsed Light Treatment System
- K192773 — ALLIVE
- K193030 — Avenir Muller Stem, Avenir Cemented Hip Stem
- DEN190016 — cobas vivoDx MRSA
- K182758 — MCI - CMF System
- K190660 — G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System Vivacit-E Vitamin E Highly Crosslinked Polyethylene
- K191191 — Neodent Implant System - Temporary Abutments
- K191250 — Southern Implants PEEK Abutments
- K191760 — PICO 14 Single Use Negative Pressure Wound Therapy System
- K191804 — TOMi Scope
- K191864 — 21HK512D
- K191962 — Vitra 2
- K191996 — BC Reflex Uni Knee System
- K192224 — BTL-899
- K192482 — Elekta Unity
- K192766 — Digital Intraoral Imaging Plate System
- K193028 — MEDRAD Mark 7 Arterion Injection System
- K191371 — MolecuLight i:X
- K191379 — RELiZORB
- K191759 — Medline Quick Switch Valve with ENFit Connector
- K192335 — TRACKER Kyphoplasty System
- K192348 — SICAT Implant V2.0
- K192430 — Epic 980
- K193020 — VenaPro Vascular Therapy System
- K193068 — AIROS 8 Sequential Compression Device
- K193069 — AIROS 6 Sequential Compression Device
- K183371 — Deka Tiac 1
- K191522 — Straumann Modular Cassette
Data sourced from openFDA. This site is unofficial and independent of the FDA.