FDA 510(k) clearances — page 311
clearances on record, most recent first.
Clearances — page 311
31,001–31,100 of 176,542- K162127 — Bencox M Stem Lateralized & Bencox Mirabo Cup System
- K163098 — Tri-Staple 2.0 Intelligent Cartridge
- K163222 — Discovery Pico Family
- K152266 — Altrix Precision Temperature Management System
- K152664 — TAV System
- K152813 — FS-500DDR Medical Radiographic X-Ray System
- K160377 — V-varnish Premium
- K160566 — Cerasorb Ortho Foam
- K161329 — Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel
- K161682 — GE Lunar DXA Bone Densitometers with enCORE version 17
- K162066 — Reliance Spinal Screw System
- K162418 — Pioneer Plus Catheter
- K162552 — EVS 3643, EVS 3643G
- K162859 — Allura Xper FD series and Allura Xper OR Table series
- K162972 — ExactVu High Resolution Micro-Ultrasound System
- K163158 — MEDSYNAPSE Zero Footprint Viewer
- K150960 — WoundPro Negative Pressure Wound Therapy System
- K152327 — EasyLyte Na/K/Cl/Ca Analyzer
- K152420 — AK Body Toning Device
- K160157 — LOSPA Modular Knee System
- K161128 — Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply
- K161470 — Internal Distraction - Sterile
- K161548 — Osseointegrated Fixtures
- K161704 — Phasor Drill
- K161906 — SCIg60 Infuser
- K162140 — RemLogic
- K162176 — Fiagon Navigation System
- K162351 — SeaSpine® Vu aPOD Prime NanoMetalene® Intervertebral Body Fusion Device
- K162468 — ClearCheck
- K162676 — Voyant Open Fusion Device
- K163009 — Litho
- K163019 — CareView 750Cw/750C X-ray Flat Panel Detectors
- K163053 — Lumipulse G E2-III Calibrators
- K163067 — CyMedica e-vive System; CY-1000
- K163106 — CODMAN Integrated Bipolar Cord and Tubing Set
- K153317 — HEMASORBPLUS Resorbable Hemostatic Bone Putty
- K161323 — Solution Set for Epidural Use
- K161391 — DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives
- K161431 — SimplECG
- K161834 — One Drop Blood Glucose Monitoring System
- K162214 — Protek Solo 24 Fr Venous Cannula Set
- K162450 — ESPADA Acne-Clearing Blue Light Pen
- K162966 — TxRx Knee 15 Flare MR Coil 1.5T
- K163043 — Zeramex P6 Dental Implant System
- K163092 — TubeClear Control Box and Clearing Stem
- K163102 — ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mm
- K163138 — Clarius Ultrasound System
- K163139 — PleuraFlow System with FlowGlide
- K160642 — Medline ENFit Syringe
- K160801 — Well Lead Extraction Bag
- K161013 — InnoSEAL Hemostatic Pad
- K161776 — Lenstec LC Injection system
- K162414 — UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System
- K162466 — LuminScan (TM) Imaging System
- K163066 — TxRx Knee 15 Flare MR Coil 3.0T
- K160530 — Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff
- K160720 — Carriere Motion Clear Class II
- K161932 — Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink
- K161962 — VAMP Venous/Arterial Blood Management Protection System
- K162211 — AccuFit Lateral Plate System
- K162451 — Solana HSV 1+2/VZV Assay
- K163207 — Filtek One Bulk Fill Restorative
- K161819 — NNR06 Multi-Purpose Solution
- K162183 — Vantage Galan 3T, MRT-3020, V4.0
- K160545 — GAP ENDO-EXO MEDULLARY SYSTEM
- K160705 — Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,
- K160872 — PolyPlex Wound Dressing
- K160940 — Masimo Disposable Transflectance Forehead Sensor
- K161264 — TRIGEN Low Profile Bone Screws
- K161696 — aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5
- K161863 — ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)
- K161957 — W&H Implantmed SI-1015 incl. Accessories
- K162103 — Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye)
- K162148 — Allura Xper R9
- K162396 — SILK Surgical Suture
- K162444 — Xpert MRSA NxG
- K162462 — AMICUS Separator System, AMICUS Separator System; Refurbished
- K163007 — Biomet Microfixation SternaLock 360 Sternal Closure System
- K152906 — Disposable High Pressure Injector Syringe
- K153021 — Fingertip Pulse Oximeter A310
- K153773 — Disposal Lens Cleaning Sheath
- K160594 — MRWire Guide Wire
- K160761 — DW-1C
- K160855 — U&U Enteral Syringe
- K160884 — CXI Support Catheter
- K161277 — ConvertX Nephroureteral Stent System
- K161408 — Compass Cast and MAP
- K161435 — Temporary Snap Abutment
- K161708 — Arm automatic blood pressure monitor
- K161747 — LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5 +2 more
- K161763 — Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device
- K161778 — ToeTac 10° Hammertoe Fixation System
- K161873 — Pacel Flow Directed Pacing Catheter
- K161993 — Leva® Anterior Interbody System
- K162043 — NobelProcera HT ML FCZ Bridge
- K162092 — Evolv Model BP7000 Upper Arm Blood Pressure Monitor
- K162102 — MAGNETOM Avantofit, MAGNETOM Skyrafit
- K162191 — NAVILAS Laser System
- K162218 — Pain Freeze, Medium Stream Spray, Model #2101; Pain Freeze, Mist Spray, Model #2102
- K162225 — WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System
Data sourced from openFDA. This site is unofficial and independent of the FDA.