FDA 510(k) clearances — page 178
clearances on record, most recent first.
Clearances — page 178
17,701–17,800 of 175,699- K202391 — DIR 800
- K202408 — cobas CTNG for use on cobas 6800/8800 systems
- K202507 — EEA Circular Stapler with Tri-Staple Technology
- K202595 — Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask
- K202672 — Precision Delivery Infusion Set
- K202839 — Overlapped Compression Therapy
- K202904 — Surgical Face Mask
- K203189 — AEROCURE-MD
- K202629 — Dentsply Sirona Universal Spray Glazes
- K192913 — R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose
- K200163 — Ava Fertility Tracker
- K201219 — Biocore9 Femoral Head Resurfacing Component
- K201685 — Potenza
- K202363 — HBP7 Settable Hemostatic Bone Putty
- K202833 — Sequel External Fixation Device
- K203153 — CREO Stabilization System, Navigation Instruments, ExcelsiusGPS
- K203485 — SnugFit All-Suture Anchor
- K203719 — IntraSight Mobile
- K203726 — ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter
- K200565 — Galapogos
- K201930 — Nanum Syringe
- K193271 — uAI EasyTriage-Rib
- K193608 — EBERLE Shaver System C3 and Accessories
- K201085 — NeVa PV Thrombectomy Device
- K201579 — Infrared Thermometer
- K201582 — Non-contact Electronic Forehead Infrared Thermometer
- K201650 — VMCore Biopsy Needle
- K201897 — Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525
- K202107 — Medical Protective Mask
- K202141 — Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set
- K202653 — Gymform Total ABS
- K202767 — Vantage Orian 1.5T, MRT-1550, V6.0
- K202826 — IMMULITE® 2000 Cortisol
- K202847 — AccuBrain
- K203142 — Veuron-Brain-pAb
- K203209 — AirPhysio Positive Expiratory Pressure (PEP) Device
- K203270 — IMMULITE/IMMULITE® 1000 Cortisol
- K203308 — Ali Interbody Fusion System
- K203381 — Dynanail Mini Hybrid
- K203506 — PERLA® TL posterior osteosynthesis system
- K203677 — ViewPoint 6
- K203678 — CD HORIZON Spinal System
- K203683 — CarboClear Lumbar Cage System
- K200702 — EasyPath RF Introducer Sheath
- K201719 — Vital Sleep
- K201922 — Trophikos Vaginal Moisturizer
- K202019 — Maven Patient-Specific Instrumentation
- K202104 — BioGuard EUS Air/Water and Suction Valves
- K202333 — Lockado Repositionable Hemostasis Clip
- K202694 — Vycor Medical Viewsite Brain Access System (VBAS) and VBAS with Alignment Clip (VBAS AC) (together the VBAS Family)
- K202700 — ART-Plan
- K202769 — VELYS Robotic-Assisted Solution
- K203241 — OmniGuide BeamPath OTO-U Fiber
- K203669 — Mobius3D
- K192933 — Polyisoprene Powder Free, Black Colour Surgical Gloves
- K200609 — ENTity WiFi Video Nasopharyngoscope System
- K201014 — MyOnyx System
- K201700 — BEGO Semados® RS/RSX Implant System
- K202314 — Procedure face mask (Model: KKF-2A)
- K203105 — Inion CompressOn Screw
- K203639 — StealthStation Cranial Software v1.3.2
- K203671 — M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System
- K201625 — Disposable Medical Surgical Mask
- K201836 — Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i
- K202843 — Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)
- K203129 — NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System
- K203201 — NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Hyperlordotic System, Brigade Standalone System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, Modulus ALIF System
- K203280 — Hepatica v1 (Hepatica v1.0.0)
- K203526 — C Scope Visualization System
- K203658 — Micro C Medical Imaging System, M01
- K193079 — ICE COMPRESSION FIRST, DUO, & MOOVE Systems
- K201241 — Striate+
- K201471 — M-Vizion Femoral Revision System Extension
- K202505 — GetSet Surgical GoPLF! Posterior Lateral Fusion System
- K202577 — Medical Surgical Mask-Model MP002-5, MP002-6
- K203231 — Switched Internal Paddles
- K203397 — Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm
- K200717 — CLEWICU System (ClewICUServer and ClewICUnitor)
- K202874 — Puritan Bennett Cuff Pressure Manager
- K201259 — ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System
- K201778 — i-STAT TBI Plasma cartridge with the i-STAT Alinity System
- K202017 — Passion Natural Water Based Lubricant
- K202278 — OBS Anchorage Screw, Biokey Anchorage Screw
- K202291 — Button Loop
- K202721 — Celerity 20 Steam Biological Indicator for IUSS
- K203114 — LOGIQ P10, LOGIQ P9, LOGIQ P8
- K203329 — HeartFlow Analysis
- K203341 — ACS LD Uni FB Knee System
- K203630 — BioGuard Air/Water and Suction Valves
- K200918 — SurgiWrap FROST
- K201577 — MatriDerm
- K202405 — BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1
- K202414 — BrainInsight
- K202488 — ZSFab Cervical Interbody System
- K202544 — Instylla Delivery Kit
- K202622 — Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate
- K203117 — TissueTak device
- K203345 — MULTIX Impact
- K200021 — Applied Medical Anoscope
- K200382 — BTL-703-2
Data sourced from openFDA. This site is unofficial and independent of the FDA.