FDA 510(k) clearances — page 257
clearances on record, most recent first.
Clearances — page 257
25,601–25,700 of 175,699- K180360 — OKTAGON Implant System
- K180625 — Rondek PGA Suture (Beige or Violet)
- K180642 — Pro-Link® Ti Stand-Alone Cervical Spacer System
- K180937 — Graftgun Universal Graft Delivery System
- K180961 — RadiForce MX194
- K172145 — Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion 120 days, Invia Motion 60 days, Invia Motion 30 days, Invia Motion 15 days, Invia Motion 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad
- K172191 — STERIZONE VP4 Sterilizer
- K173202 — CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set
- K173309 — Faxitron VisionCT
- K173311 — ARTHRO-Pump PA304
- K173452 — EmboTrap ll Revascularization Device
- K173572 — DSM Biomedical Calcium Phosphate Cement with Microspheres
- K180279 — Silk'n MODEL H5003 device
- K180461 — Navi e/Navi s/Navi X Diagnostic Ultrasound System
- K180913 — VSI Micro-Introducer Kit
- K180929 — Klassic HD® Hip System
- K180932 — Diamond Orthopedic Bone Fixation Screws and Pins
- K181032 — Halcyon
- K171690 — Trident Extremity Fixation System
- K172471 — VENTANA CD30 (Ber-H2) RxDx Assay
- K172484 — A-CIFT SoloFuse
- K172661 — Fetzer Medical Gynecological Forceps
- K173004 — SB Soft Hood - Straight type, SB Soft Hood - Undercut type
- K173347 — STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX
- K173510 — BioStamp nPoint
- K173831 — Glidesheath Slender
- K173901 — MyoSure MANUAL Tissue Removal Device
- K173912 — BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube
- K180386 — Meron Plus QM
- K180922 — Empower H100, Cyber Ho 100, Litho 100
- DEN170015 — Hemospray Endoscopic Hemostat
- K180031 — Endopath Electrosurgery Probe Plus II
- K180034 — Weinmann Tracheostomy Exchange Set
- K180079 — Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation
- K180296 — Afinion HbA1c Dx
- K162021 — 3.0 Dynamic TiBase
- K172100 — URIS OMNI System
- K172271 — Trackit T4 EEG Amplifier
- K172568 — Cervage
- K172614 — Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, Left
- K173345 — TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System
- K173684 — g.Estim PRO
- K173711 — Wallaby Avenir Coil System
- K173874 — StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO
- K173892 — NuVasive® XLX Interbody System
- K173913 — MEDRAD® Imaging Bulk Package Transfer Set
- K180157 — QT ECG
- K180313 — Apollo TMS Therapy System
- K180317 — EVOLUTION® Knee Systems MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, EVOLUTION® Revision CCK System
- K180437 — Hexanium® TLIF
- K180623 — Ulthera System
- K180641 — Invenia ABUS Viewer
- K180740 — VitriGuard
- K180891 — EVOL Spinal Interbody System, EVOS Lumbar Interbody System
- K171007 — Fluorescence Mode
- K171577 — Smartcord, Smartcord X
- K172137 — PIEZOTOME CUBE
- K172777 — Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7
- K172980 — Micropuncture Pedal Access Set
- K173540 — Brainsway Deep (DTMS) System
- K180019 — CAAS Workstation
- K180071 — STYLO Interbody Fusion Device
- K180162 — VivaScope System
- K180214 — Repris Bladder Injection System
- K180939 — Indigo Aspiration System - Modified 110 Aspiration Tubing
- K181001 — Medtronic Confida Brecker Guidewire
- K172409 — Lite
- K172864 — Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
- K173653 — Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit
- K173807 — Accu O2 Oxygen Analyzer
- K173825 — MC 300R* Nebulizer
- K173861 — Drug Relief
- K173946 — ADAPT for Gamma3
- K180028 — Cook 810 Set, Desilets-Hoffman Introducer Set
- K180264 — Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
- K180352 — 7D Surgical System
- K180599 — Venue
- K180796 — Spineology Navigation Instruments
- K172412 — BacterioScan 216Dx System
- K172554 — LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing
- K172555 — SAPPHIRE, ELEVARE SAPPHIRE
- K172656 — BiliLux
- K172959 — PeraServer and PeraTrend
- K173035 — Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets
- K173300 — ViaTherm BOOST
- K173718 — Liberty Cycler Set
- K180848 — AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches
- K171678 — Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable
- K172636 — VitaMESH Macroporous PP Surgical Mesh
- K172726 — EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D
- K173304 — Finessis Intense Polyisoprene Surgical Glove
- K180307 — Mazor X
- K180636 — ExactVu High Resolution Micro-Ultrasound System
- K180696 — Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal (Tested for use with Chemotherapy Drugs)
- K171151 — ACRON TLIF System
- K172166 — OLYMPIC Navigated Instruments
- K172258 — Novasight Hybrid System
- K172460 — ADHEAR System
- K172720 — TRACOE silcosoft Tracheostomy Tube
- K172747 — HYALURONIC ACID TOPICAL WOUND CREAM
Data sourced from openFDA. This site is unofficial and independent of the FDA.