FDA 510(k) clearances — page 291
clearances on record, most recent first.
Clearances — page 291
29,001–29,100 of 176,542- K170388 — ANCHORMAN Tibial Ligament Fixation Device
- K170600 — CARTO 3 EP Navigation System, Version 6.0 and Accessories
- K170770 — CT Midline
- K170867 — FTRD System Set
- K170997 — CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath
- K171255 — Monteris Medical NeuroBlate System
- K171630 — LumFuse-TP
- K171645 — CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle
- K171734 — HP PRO Positioning Device
- K171837 — TomoTherapy Treatment Delivery System with iDMS
- K171885 — Radiance V4
- K171913 — Rubicon 14, 18 and 35 Support Catheters
- K171967 — MagVita TMS Therapy System
- K162633 — Custom Bars
- K162858 — NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST
- K162991 — YELLOW 560 Fluorescence Module
- K163295 — Infant Transport Mattress Warmer with Disc
- K163486 — DRACO Locking Bone Screws +4 more
- K170923 — JAWS(TM) Nitinol Staple System
- K171285 — ARIX Diaphysis System
- K171364 — MP LeFort I Plates
- K171559 — True Spinal Fixation System
- K171724 — Rampart L Lumbar Interbody Fusion Device
- K171962 — Klassic HD® Hip System
- K162950 — VITEK MS
- K152257 — Fujifilm Duodenoscope Model ED-530XT
- K161527 — Teco Creatinine Enzymatic Reagent Kit
- K162778 — Portable Slit Lamp Microscope
- K163232 — Vitrea View
- K170223 — Progreat
- K170532 — True Form Reshapable Guide Wire
- K170832 — Ultimax-i, DREX-UI80 V1.60
- K171003 — 3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader
- K171441 — ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit
- K171597 — Vantage Elan 1.5T, V4.0
- K171753 — BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16
- K171855 — External Moisturizing Gel
- K162219 — CADD® Infusion Disposables Portfolio with NRFit connectors
- K163025 — DORA Disposable A.V. Fistula Needle Sets
- K163589 — SIGN IM Nail
- K170219 — Microlife Digital Infrared Ear Thermometer
- K170326 — dynaMX Intramedullary Implant
- K171425 — CONCORDE LIFT
- K171439 — EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, UNIPLATE 2 Anterior Cervical Plate System
- K171616 — Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color
- K171701 — GelPOINT Path Transanal Access Platform
- DEN170022 — QuantX
- K163159 — Dario Blood Glucose Monitoring System
- K163388 — XPress BCD Breast Compression Device
- K163687 — OLINDA EXM
- K170182 — CARDIOVIT FT-1
- K170379 — Disposable Standard Clamp
- K170675 — Graftgun Universal Graft Delivery System
- K170775 — Mini Stick ENVI Non-Vascular Introducer Kit
- K170852 — POD Packing Coil
- K170978 — Embrace Neonatal MRI System
- K171093 — STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE
- K171290 — Vela RX PTA Balloon Dilatation Catheter
- K171812 — Nio Color 2MP (MDNC-2123)
- K171838 — TiLock2 Spinal System
- K171957 — MaxZero Extension Sets with Needless Connector
- K162510 — Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue
- K162856 — Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)
- K163064 — Demi Ultra
- K163714 — OSSIX BONE
- K170100 — CreoDent Solidex Customized Abutment and Screw
- K170729 — Examion X-AQS
- K170786 — Faxitron Bioptics Speciemen Radiography System
- K171021 — JO Agapé Personal Lubricant
- K171149 — Altrix Temperature Management Wraps
- K171333 — 20G x 5/8 Pro-Lock CT Safety Infusion Set
- K171544 — Arterys Viewer
- K171807 — ES2 Neuromonitoring Accessory Instruments
- K171824 — Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System
- K171844 — Inspire ICE aka Inspire ICE Clear Brackets
- K162957 — U2 Femoral Head
- K170407 — BD ChloraShield IV Dressing with CHG Antimicrobial
- K170607 — !M1
- K170613 — Genius Total Knee System
- K171115 — 3D Endo Software
- K171404 — BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)
- K160712 — VITROS Chemistry Products hsCRP Reagent
- K162153 — Integra® CAPTURE Screw System & Integra® Ti6® Internal Fixation System
- K162698 — MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer
- K162707 — Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload
- K162803 — Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts
- K162853 — Bonafix TWO - Dental Implant System
- K163150 — ViMove2
- K163194 — Neodent Implant System - GM Line
- K163318 — Soules Intrauterine Insemination Catheter
- K170090 — RTHawk, HeartVista Cardiac Package
- K170518 — In2Bones Fracture and Correction System
- K170637 — sensiFirm
- K170686 — Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs
- K170710 — True Spinal Fixation System
- K170757 — Aegis Transit System
- K170798 — Dictum Health
- K171029 — eCareCoordinator
- K171128 — SIGNA Premier
- K171242 — Alma LipoFlow System
Data sourced from openFDA. This site is unofficial and independent of the FDA.