FDA 510(k) clearances — page 288
clearances on record, most recent first.
Clearances — page 288
28,701–28,800 of 175,699- K162433 — GCE Zen-O Portable Oxygen Concentrator
- K162463 — Matrix Data Management System
- K163071 — vascuCAP
- K163172 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
- K163196 — ACTION II Laser System
- K163197 — Cook Holmium Laser Fiber
- K163244 — truFreeze System
- K163257 — VitreOx Anti-fog Solution
- K163618 — INDIGO Aspiration System
- K170172 — UNiD Spine Analyzer
- K170287 — Dental Implants OKTAGON Bone Level Tapered Design
- K170290 — Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr
- K170306 — FIBERGRAFT BG Putty Bone Graft Substitute
- K170349 — RA-308 Excimer Laser System, Excimer Laser Catheter
- K170514 — Central Monitoring System
- K170603 — Tao Brush I.U.M.C. Endometrial Sampler
- K170779 — Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein
- K170891 — Mako Partial Knee Application
- K171194 — AS-10, CXDI-401RF
- K161833 — LATEX EXAMINATION GLOVE POWDER FREE
- K162598 — HAPI Seal
- K163090 — Plasma Edge System
- K163430 — Prontosan Wound Gel
- K163658 — ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay
- K163673 — Fortilink-C with TETRAfuse 3D Technology
- K170489 — Skylit Phototherapy System
- K161689 — OSSTEM Implant System - Abutment
- K163394 — Hybrid3D
- K163553 — Powder Free Nitrile Patient Examination Gloves, Blue
- K170021 — SMV Scientific Cannulated Screws
- K170121 — Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories
- K170282 — Smith & Nephew VISIONAIRE Adaptive Guides
- K170586 — Strep B Carrot Broth One-Step
- K170989 — Dymaxeon Spine System
- K171348 — Pinpoint GT Needle Guide Kits
- K170446 — LT-300 SD Digital Video Colposcope
- K160109 — Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber
- K160677 — MICRORUPTOR 6
- K161807 — BEAMSCAN
- K161813 — Frova Intubating Introducer
- K162212 — DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
- K162542 — OsteoMed PINNACLE Driver
- K163073 — Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder
- K163261 — AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip
- K163564 — SLIT LAMP SL-2000
- K163610 — PIEZOTOME M+, PIEZOTOME M+ Handpiece
- K163644 — Nihon Kohden QP-160AK EEG Trend Program
- K170018 — StealthStationTM S8 ENT Software
- K170303 — E5 Series Digital Color Doppler Ultrasound System
- K170322 — Catalys Precision Laser System
- K170509 — BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set
- K170752 — OEC Elite
- K170874 — Eko Model E5 System (EME5), Eko DUO
- K170908 — PK AIM
- K171152 — Stryker Universal Neuro III System AXS Screw
- DEN170019 — Vitamin D 200M Assay for the Topaz System
- K160509 — Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube
- K160567 — Barone Jejunostomy Catheter Set
- K161272 — Supreme and Response Electrophysiology Catheters
- K162716 — bibag
- K170639 — HEALIX ADVANCE Anchor with PERMATAPE Suture
- K170804 — The Solstice OCT System
- K171135 — Lipogems System
- K171139 — LaparoLight Veress Needle
- K171165 — SmartByte Device
- K153748 — AirLife Misty Finity Nebulizer
- K160398 — MRI Compatibility for Existing Zimmer Dental Implant Systems
- K161601 — Dynamika
- K162378 — FREND PSA PLUS (reagent cartridge)
- K163094 — TinniLogic Mobile Tinnitus Management Device
- K163669 — Humeris Shoulder
- K170078 — Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley
- K170082 — Test of Variables of Attention (T.O.V.A.) Version 9.0
- K170195 — QuantX
- K170196 — A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor
- K170828 — Cardiac Trigger Monitor
- K171138 — Nexus DR Digital X-ray Imaging System
- K171355 — Surefire Precision Infusion System
- K162133 — VerteFIT Corpectomy Cage System
- K163002 — Kangaroo Feeding Tube with IRIS Technology
- K163181 — TRANSLACE Spinal Tethering System
- K163226 — EPIC Extremely Small Staple
- K163502 — iSR'obot Biopsy Kit
- K163701 — Direxion and Direxion HI-FLO Torqueable Microcatheters
- K170245 — DSM Biomedical Dental Bone Graft
- K170338 — A-View
- K170462 — KARL STORZ ShuntScope
- K170481 — Strep B Carrot Broth Kit
- K170496 — Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory
- K170500 — SIROLaser Advance+
- K170575 — Disposable Powder Free Vinyl Exam Glove, Clear/Yellow
- K170680 — TEVADAPTOR Closed Drug Reconstitution and Transfer System
- K171020 — Arthrex Knotless SutureTak Anchor
- K171168 — VITROS Immunodiagnostic Products Insulin Calibrators
- K171327 — Tyber Medical Wedge System
- K153410 — 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing
- K163557 — SS SA Fixture
- K163638 — Dental 5 Multi Diode laser
- K170023 — SPiN Thoracic Navigation System
- K170312 — IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools
Data sourced from openFDA. This site is unofficial and independent of the FDA.