FDA 510(k) clearances — page 186
clearances on record, most recent first.
Clearances — page 186
18,501–18,600 of 176,479- 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
- K200560 — InBody
- K200769 — Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B
- K200999 — Thermidas IR System (ThIR-A615)
- K202350 — SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System
- K202491 — Disposable Surgical Face Mask
- K202495 — SIRION Lateral Lumbar Interbody Fusion
- K202594 — Medical Surgical Masks-Non Sterile
- K202810 — AutoStrut G2
- K202844 — Medical Surgical Gowns
- K203339 — NEOLab Clear Aligners
- K203340 — MULTIX Impact C
- K203465 — OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design
- K203652 — Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D
- K193273 — Insulin Syringe
- K193497 — Fixone Biocomposite Interference Screw
- K200159 — Non-contact Infrared Body Thermometer, model:HTD8823US
- K200298 — ABI Instrument, Creo Electrosurgical System
- K200491 — Bfix Orthopedic External Fixator Systems
- K200963 — Halo Single-Loop Microsnare Kit
- K201114 — Bidop 7
Data sourced from openFDA. This site is unofficial and independent of the FDA.