FDA 510(k) clearances — page 135
clearances on record, most recent first.
Clearances — page 135
13,401–13,500 of 176,479- K222500 — AIR OPTIX COLORS
- K201049 — FINDER G6PD
- K212618 — iRelieve Microcurrent Pain Relief System
- K213293 — V-HEPES PLUS
- K213854 — SavvyWire
- K220418 — Tornier Perform Humeral System Stemless
- K220978 — TSX Implants
- K220979 — SprintRay Denture Base
- K220990 — Qorda QD1
- K221707 — SafeSept® Transseptal Guidewire (SS-140)
- K221761 — Solea
- K221797 — BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device
- K221843 — GEM Biover Microvascular Clamps
- K222078 — Arthrex SoftStitch
- K222091 — Grappler Suture Anchor System
- K222331 — WatchPAT300 (WP300)
- K222503 — Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip
- K222764 — LightForce Orthodontic System
- K210929 — MagiCath II
- K212147 — Simplexa COVID-19 Direct
- K213575 — Female IC (Not Finalized)
- K213770 — SP-CL Hip Stem and LCU Hip System
- K214035 — LAITEST Medical Face Mask
- K220239 — Solid State X-ray Imager(Model: FXRD-4386WB)
- K220953 — ChoiceSpine TigerShark M, Modular Interbody System
- K221092 — Transcutaneous Electrical Nerve Stimulator Model: ST-304
- K221140 — P20 Elite Series Digital Color Doppler Ultrasound System
- K221417 — CLAROX plus (Model: VX-100)
- K221425 — Primary Relief
- K221733 — MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit
- K221748 — Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves
- K214024 — SOFIA 88 Catheter
- K220084 — Infrared Forehead Thermometer
- K220986 — Aquilion Precision (TSX-304A/4) V10.10 with AiCE
- K221450 — Phosphoric Acid Etching Gel
- K221456 — Rapid ICH
- K221533 — Plasma Shield
- K221568 — KOLO Evolution XHD Series Ultrasound Diagnostic System
- K222512 — Integrity-SI Fusion System
- K213244 — Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration)
- K214028 — MICOR Lens Fragmentation System
- K220002 — Dexus Prosthetics System (Model: MSL1, MSR1)
- K220659 — AUTOBAHN(R) EVO Femoral Nails
- K220859 — Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black)
- K220944 — PointCore Surgical Mask
- K221354 — Arthrex SutureTape
- K221388 — NuVasive Reline Cervical System
- K222093 — V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System
- K222429 — Ellusa Reusable Bipolar Cable
- K222440 — Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays
- K222723 — AMBARINO High-Class
- K210973 — MammaPrint FFPE NGS Kit
- K211648 — Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
- K213267 — Dynamis Pro Family
- K213947 — Ultrasonic Endo Activation Device (Model:Actor I pro)
- K213989 — Cranial EM System
- K220143 — BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens
- K220330 — Soundly Anti Snoring Device
- K220595 — NeoNavia Biopsy System
- K221331 — Disposable Endoscope Valves System
- K221684 — Osstem Abutment System
- K222020 — HD-550 Video Endoscope System
- K222076 — EFAI ChestSuite XR Pleural Effusion Assessment System
- K222409 — CAPTIVATE® Compression Screws
- K222425 — Ellusa Reusable Neutral Plates
- K203594 — EyeCTester
- K220112 — AXIOS Stent and Electrocautery-Enhanced Delivery System
- K220567 — Easi-Vue embolic microspheres System
- K220783 — syngo.via RT Image Suite
- K220920 — Matreneu Percutaneous Balloon Compression Kit
- K221731 — FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire
- K222034 — RightLance Blood Lancing System
- K222110 — Mariner RDX System
- K222111 — Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G
- K211858 — TULSA-PRO System
- K213868 — ASAHI Gladius Mongo18 PV ES
- K213960 — LiverMultiScan v5 (LMSv5)
- K220251 — Neodent Implant System - GM Narrow Implant System
- K220962 — ROTAPRO Rotational Atherectomy System
- K221283 — Hammertoe Truss System (HTS)
- K221636 — EMPHASYS Acetabular System
- K221929 — Smith+Nephew INTELLIO Tablet
- K222048 — Spectrum IQ Infusion System with Dose IQ Safety Software
- K222069 — Ez3D-i/E3
- K203503 — Camber Sacroiliac (SI) Fixation System
- K211178 — DURAMESH Mesh Suture
- K212189 — FibroLux
- K212222 — Soniquence Reusable 3 Button Fingerswitch Wand
- K213287 — StageOne Knee Cement Spacer Molds
- K213855 — Arrow Pressure Injectable Midline Catheter
- K213864 — Bonebridge Osteosynthesis Plating System
- K213983 — Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear
- K221085 — LiNA OperaScope Needle
- K221277 — Mygen M-3004 RF Generator M-3004
- K221414 — ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter
- K221557 — Visera Hysterovideoscope Olympus HYF Type V
- K221644 — Synthetic Bone Putty
- K221932 — Omni Legend
- K221957 — Savewo ClassicMASK
- K222075 — CellFX System
Data sourced from openFDA. This site is unofficial and independent of the FDA.