FDA 510(k) clearances — page 230
clearances on record, most recent first.
Clearances — page 230
22,901–23,000 of 175,699- K190664 — RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review
- K181296 — Syntec Femoral Nail System
- K181361 — Brux Night Guard
- K181758 — ELRA Electrode
- K183398 — Endoform Restella
- K183526 — Codman Electrosurgical Generator, Foot Pedal
- K190058 — PureSleep (OTC use)
- K190070 — Sonopet iQ Ultrasonic Aspirator System
- K190317 — Zavation Spinal System
- K190453 — VisCalor bulk
- K190786 — Eye Prime
- K181110 — PROPHYflex 4
- K182582 — Oryum and Ovem Epidermal Deri Prick Test Applicator
- K182662 — NAV PAK Needle, NIM NAV PAK Needle
- K183057 — PUMA-G System
- K183306 — GLUCOCARD® W onyx Blood Glucose Monitoring System
- K190175 — S-MAK XL
- K190295 — Confirm Rx Insertable Cardiac Monitor
- K190631 — M.U.S.T. MINI Posterior Cervical Screws System
- K181832 — Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device
- K182333 — Vera
- K182341 — Pantheris SV
- K182770 — Adult Intraosseous Infusion Device
- K183660 — DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System
- K190327 — ENConnect 40 mm Screw Cap to ENPlus Adapter
- K190653 — ExcelsiusGPS
- K182375 — CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS®
- K183204 — Bone VCAR (BVCAR)
- K183496 — JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor
- K183539 — Ergoline Sunrise 7200 Hybrid Technology
- K183550 — Vitality® Spinal Fixation System
- K183606 — Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)
- K183682 — OIC External Fixation System
- K190040 — Straumann BLX Line Extension - New Abutments
- K190611 — VIVIX-S 1751S
- K182287 — MEDINAUT Plus
- K173770 — OJR215 Pressure Relief Manifold
- K181919 — Patient Monitor
- K182175 — TCD-X
- K182268 — EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)
- K183287 — Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K183361 — EkoSonic Endovascular Device with Control Unit 4.0
- K183494 — R190/R191 LCD Monitor
- K190038 — Xbody Newave USA
- K190103 — V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System
- K190581 — Amplatzer Trevisio Intravascular Delivery System
- K190598 — CROSSWAY Spinal Access System
- K173238 — ToxCO
- K180843 — HIgH-Flo Super26 Subcutaneous Needle Sets
- K181931 — GMC Upper Arm Automatic Blood Pressure Monitor
- K182253 — FUJIFILM Video Bronchoscopes
- K182399 — Park Blade Septostomy Catheter
- K182943 — VERTEX Nitinol Staple System
- K183197 — PYRAMESH Implant System
- K183304 — Prettau, ICE, Z-White zirconia blanks
- K183377 — DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System
- K183445 — Erbe APCapplicators
- K190164 — CleverLock Guidewire Locking Device and Biopsy Cap
- K190416 — Dome Electrode
- K190691 — Pixx2430 Digital Diagnostic X-Ray Receptor Panel
- K180232 — DAEHAN Disposable CUP Electrodes
- K182349 — CONCORDE LIFT
- K182597 — Infrared thermometer
- K182872 — LINK GEMINI SL Total Knee System
- K183184 — FlareHawk Interbody Fusion System
- K183376 — HORIZON TMS Therapy System with Navigation
- K190230 — iFuse Implant System®
- K190289 — Karma® Fixation System
- K190520 — VITROS XT Chemistry Products GLU-Ca Slides
- K190557 — Bio-Medicus Insertion Kit
- K190586 — Monster® Screw System
- K181171 — Zimmer Biomet Ceramic Heads
- K182836 — FUJIFILM Endoscope Model EG-740N
- K183320 — Ilumien Optis, Optis Integrated, Optis Mobile
- K190131 — AcQMap High Resolution Imaging and Mapping System
- K190248 — ARIETTA 50
- K181597 — Le'Pen
- K182221 — Bencox Mirabo Cup Multi Hole
- K183343 — Vantage Total Ankle Flat Cut Talar Components
- K190180 — CUSA Clarity Ultrasonic Surgical Aspirator System
- K190198 — Microperimeter MP-3, Microperimeter MP-3 Type S
- K190447 — 7400 Ultrasound Systems
- K190629 — DBSWIN and VISTAEASY Imaging Software
- K180903 — 3880 MRI Patient Monitoring System
- K180924 — Reflect Implant System
- K181352 — Loop System
- K181770 — Intrauterine Access Balloon Catheter, Selective Salpingography Catheter
- K181777 — AggreGuide A-100 ADP
- K182123 — ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card
- K182164 — Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand
- K182609 — Delphos Implants Rigid Fixation System
- K182720 — Freedom Spinal Cord Stimulator (SCS) System
- K182834 — CS-series-FP with Optional ROI Accessory CA-100S
- K182965 — BL-Cart IOL Delivery Cartridge
- K182981 — Confirm Rx Insertable Cardiac Monitor
- K183210 — Thoracic VCAR with GSI Pulmonary Perfusion
- K183508 — Micro Transgastric-Jejunal Feeding Device
- K183579 — Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits
- K183596 — Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly
- K190023 — BTL-084
Data sourced from openFDA. This site is unofficial and independent of the FDA.