FDA 510(k) clearances — page 126
clearances on record, most recent first.
Clearances — page 126
12,501–12,600 of 175,620- K220129 — Promisemed X-Safety Pen Needle
- K220839 — Arthrex Compression FT Pins
- K221638 — Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3
- K221819 — 35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS Surgical Gown;43g Reinforced SMMS Surgical Gown ;50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown;BVB Surgical Gown
- K221839 — Lancet
- K222121 — C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitor, JUSHA-C630 LCD monitor
- K222131 — NB 1 SA Implant System
- DEN220025 — Phagenyx System
- K202929 — Nexpowder
- K211027 — Altus Spine Pedicle Screw System
- K212217 — Tempo Smart Button
- K212926 — AllureTM Surgical Mask
- K220134 — cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH
- K220297 — True Tulip, True M.I.S.
- K220339 — Esthetic Abutments Nobel Biocare N1
- K220441 — CYGNUS MoRe Anterior Cervical Plate System
- K220553 — Neuro Omega System, NeuroSmart System
- K220969 — GelPOINT V-Path Vaginal Access System
- K221074 — OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device
- K221194 — LEDEX
- K221249 — L1P-1F (TRIOS 5)
- K221343 — ECHELON ENDOPATH Staple Line Reinforcement
- K221534 — Surgical Face Masks (Ear Loops And Tie-On)
- K221676 — Exsalta
- K221799 — Electric Wheelchair, Model: 9000N
- K222155 — Single Use O-ring gasket syringe with ENFit Connector, Reusable O-ring gasket syringe with ENFit connector
- K222519 — ClearPoint System
- K203336 — Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30
- K211204 — SafePort(TM) Manifold (or Stopcock)
- K213641 — MONDRIAN ALIF Cage with Supplementary Fixation Plate
- K213856 — Identity Shoulder System
- K220176 — Elecsys AFP
- K220697 — Nitrile Patient Examination Gloves, Powder Free
- K220830 — TrueBalance Surgical System
- K221089 — P12 Elite Series Digital Color Doppler Ultrasound System
- K221553 — Diamond Air+ (UI04A, UI04B, UI04C)
- K221597 — CO2 Laser System
- K221686 — NovoSorb Matrix
- K221966 — Dynamic TiBase
- K221968 — StageOne Shoulder Cement Spacer Molds
- K222468 — ArcTO Transobturator Sling System
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.