FDA 510(k) clearances — page 297
clearances on record, most recent first.
Clearances — page 297
29,601–29,700 of 176,542- 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
- K170370 — ULTRASHAPE POWER SYSTEM
- K170784 — PNEUMOCLEAR
- K171137 — EVS 2430W, EVS 2430GW
- K162333 — Wondfo One Step Fecal Occult Blood (FOB) Test
- K161261 — Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase
- K162392 — Avazzia
- K170199 — Unity Network ID
- K170228 — Belimed Steam Sterilizer MST-H TOP 5000
- K170401 — Piccolo Composite® Plate System
- K171072 — N Latex Cystatin C; N Protein Standard UY
- K171083 — iChemVELOCITY Automated Urine Chemistry System
- K171119 — GM85
- K160667 — Anybattery C2 Rechargeable Battery
- K161950 — Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle
- K161961 — UniTex Non-Sterile, Powder-Free, Latex Examination Glove
- K162328 — Winner Transfer Wheelchair
- K162566 — AIK Sterile Acupuncture Needles for Single Use
- K162667 — Kitazato IUI Catheter
- K163131 — A-dec NLZ Electric Motor System
- K163250 — Longitudinal Brain Imaging (LoBI) application
- K163276 — Fully Automatic Electronic Blood Pressure Monitor
- K163576 — GORE SYNECOR Preperitoneal Biomaterial
- K163622 — Lung Vision
- K170135 — TREFOIL System
- K170205 — Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203
- K170382 — Arthrex Compression Screws
- K170413 — BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set
- K170419 — SurgiCase Viewer
- K170491 — Solana C. difficile Assay
- K170581 — Mako Total Knee Application
- K170584 — Mako Partial Knee Application
- K170647 — Connector System
- K170648 — ANTHEM CR Total Knee System
- K170679 — CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems
- K170990 — Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator
- K171085 — GMR40
- K162125 — MALUC Total Hip Arthroplasty System
- K162348 — ABCcolla Collagen Matrix
- K163476 — Lubricity
- K170594 — I.B.S. osteosynthesis screws
- K170650 — Orthofix TrueLok Hexapod System (TL-HEX) V2.0
- K171080 — ALP IFCC Gen.2
- K171097 — MOJAVE Expandable Interbody System
- K162131 — ExSpiron 1Xi
- K163117 — Alpha Pure
- K163382 — Oxitone 1000
- K163606 — Digital Blood Pressure Monitor-Automatic Upper Arm Style
- K170342 — Ocata Anterior Cervical System
- K170393 — Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue)
- K170469 — NxStage System One Plus
- K170831 — EpiAccess System
- K171022 — Ablation Confirmation
- K171081 — Guider Catheter Introducer
- K171096 — Fujifilm Diathermic Slitter (FlushKnife)
- K151562 — Resultz Lice & Egg Removal Kit
- K161938 — Fingertip Pulse Oximeter
- K162594 — Craniomaxillofacial Distraction System (CMFD)
Data sourced from openFDA. This site is unofficial and independent of the FDA.