FDA 510(k) clearances — page 317
clearances on record, most recent first.
Clearances — page 317
31,601–31,700 of 175,699- K152251 — Endobronchial Tube
- K152744 — DIEGO ELITE DRILL
- K152747 — DSG Threaded Drill System
- K153434 — Pall-Aquasafe Water Filter
- K153659 — MaxO2ME
- K160095 — Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23oz
- K160364 — VersaWrap Tendon Protector
- K160496 — Reprocessed Inquiry Steerable Diagnostic EP Catheter
- K160555 — BLUEPRINT Patient Specific Instrumentation
- K160700 — ATTUNE Revision Knee System
- K160703 — NeuroStar TMS Therapy System
- K160975 — Aequalis PerFORM+ Shoulder System
- K160995 — NEOVIEW Plating System
- K161363 — Arsenal Spinal Fixation System
- K152011 — Lucent Intervertebral Body Fusion Device
- K152342 — Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover
- K152667 — ATOVEN-Reusable Laser Fiber
- K160204 — BSD4343 Digital Flat Panel X-ray Detector
- K160370 — BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer
- K160510 — MAKO 7
- K160526 — Masimo O3 Regional Oximeter System
- K160546 — 3M Attest Rapid Readout Biological Indicator
- K160587 — Aquilion ONE (TSX-305A/3) V7.3
- K160618 — Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T
- K160989 — NuVasive® Reline® System
- K161001 — MILAGRO ADVANCE PEEK Interference Screw
- K161180 — Oak Ridge Products Sharps Containers
- K161188 — HEPATIQ 1.1
- DEN130051 — PEDIATRIC VISION SCANNER
- K152597 — ProteXsure Safety Capsule System
- K153181 — MAIA
- K160400 — Miromatrix Biological Mesh
- K161122 — Sony IP Converter NU-IP40S
- K151137 — X-VIEW, IMAGEN
- K151250 — Smart Set
- K152786 — A Plus Internal Fixture System
- K152877 — SureFine Pen Needle
- K153388 — IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached Holder, IMPROSAFE Blood Collection Set, IMPROVACUTER Blood Collection Set, IMPROSAFE Multi Sample Needle, IMPROSAFE Multi Sample Needle (Flashback), IMPROVACUTER Multi Sample Needle
- K153713 — Getinge Series Warming Cabinet
- K160005 — Contact Lens Case (multiple brand name)
- K160232 — Disposable Barrier Sleeves and Covers
- K160474 — DSM Biomedical Porcine Pericardium Dental Membrane
- K161147 — EndoCure Model EUR078A
- K161297 — Beta-2-Microglobulin
- K142130 — ORAL BOND
- K151239 — NMI DUAL PORT II
- K152729 — MICROPERIMETER MP-3
- K153436 — LATERAL Spine Truss System
- K153534 — NobelProcera HT ML Full Contour Zirconia Crown
- DEN150040 — WallFlex Biliary RX Fully Covered Stent System RMV
- K152276 — Wing Smart FEVI and Peak Flow Meter
- K152301 — Background Pattern Classification [BPc(TM)]
- K152521 — Seal Rite Non-Rebreathing Valve
- K152561 — Communicator Surgical Facemask with Clear Window
- K152893 — Corin Optimized Positioning System (OPS)
- K152961 — VALIDATE D-Dimer Calibration Verification/Linearity Test Kit
- K152984 — Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes
- K153131 — Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner
- K153164 — LunulaLaser
- K153518 — Medipure Oxygen-LC System
- K153611 — Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device
- K153704 — Strive
- K153719 — LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream
- K160115 — Heat Pain Pro
- K160427 — dynaMX(TM) Nitinol Compression Screw
- K160617 — Large Screws Range
- K160652 — iFUSE Implant System
- K160655 — OrthoButton CL
- K160668 — HumaPen Savvio
- K160775 — Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems
- K160905 — Sonendo GentleWave System
- K161183 — Halo One Thin-Walled Guiding Sheath
- K151229 — ABC D-FLEX PROBE
- K152519 — MTR550 (Tentative) Antimicrobial Silver Wound Gel
- K152576 — Anker II Dental Implant System
- K152856 — Helios III
- K152918 — Gun Oil, Pink, Gun Oil H2O, Pink Water
- K153036 — NobelDesign Software
- K153280 — PowerGlide Pro Midline Catheter
- K153606 — LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler, Tablet Application
- K160012 — O-pel Laser and families of probe delivery devices
- K160099 — CEREC SpeedGlaze
- K160119 — NobelSpeedy Groovy
- K160244 — VARIOunite
- K161193 — 16ch Tx/Rx Knee SPEEDER
- K151987 — DCI Edge Dental Chair with Operative Unit
- K152458 — Gemini Bonded Sterilization Wrap
- K152635 — QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls
- K153056 — Hermes Medical Imaging Suite v5.6
- K153165 — NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit
- K153288 — Voyant Open Fusion Device
- K153552 — AGE Automatic Upper Arm Blood Pressure Monitor
- K160264 — Additive Orthopaedics Hammertoe Correction System
- K160485 — VERIFY VH2O2 Indicator Tape
- K160552 — EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform
- K160573 — FirstSense Breast Exam
- K160870 — Hospira Administration Sets
- K150979 — CT/MR Compatible M.A.C. Interstitial GYN Template
- K152340 — NAR Sharps Shuttle; NAR Sharps Shuttle Pack of six
- K152583 — KARL STORZ Endoscopic ICG Imaging System
Data sourced from openFDA. This site is unofficial and independent of the FDA.