FDA 510(k) clearances — page 151
clearances on record, most recent first.
Clearances — page 151
15,001–15,100 of 175,699- K212060 — neXus Ultrasonic Surgical Aspirator System
- K212186 — Philips Radiology Smart Assistant
- K212221 — Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer
- K212428 — Centerpiece Plate Fixation System
- K212706 — SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard
- K212869 — Disposable Surgical Gown, Disposable Reinforced Surgical Gown
- K212890 — Nyquist.IQ
- K212918 — Heat StimPlus
- K212924 — Nitrile Examination Gloves
- K212925 — Disposable Surgical Gown
- K213069 — CoLink NeoFuse Plating System
- K213176 — Disposable Nitrile Powder-Free Examination Gloves
- K213700 — MULTIX Impact, MULTIX Impact C
- K212085 — Siam NTD+ Nitrile Powder-Free Examination gloves
- K212182 — Iconic Nitrile Glove
- K212840 — Nitrile Gloves (Model: NE01)
- K212867 — Medical Surgical Mask
- K212899 — Disposable Vinyl/Nitrile Blend Medical Examination Gloves
- DEN200041 — Comfort Marker 2.0.
- K201600 — Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28
- K202510 — AMG PMP Infant
- K203539 — Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE)
- K203615 — Dental Scaler and Air Polisher
- K203723 — Branchor Balloon Guide Catheter
- K203743 — EXA
- K210004 — i8 Tanning Booth
- K210842 — VerSys Cemented Revision/Calcar
- K210847 — UltraClear Fractional Laser System
- K211560 — Airvo Nebulizer Adapter
- K211612 — Medline UNITE REFLEX Dynamic Discs
- K211997 — 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads
- K212137 — X-Clever
- K212176 — CINtec Histology
- K212349 — Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves
- K212435 — Comprehensive Humeral Fracture Positioning Sleeves
- K212577 — DESS Dental Smart Solutions
- K212850 — ComfortPro Blue Nitrile Examination Gloves Powder Free
- K212922 — Nitrile Examination Gloves
- K213394 — Vy Spine VySpan PCT System
- K213460 — Invictus Spinal Fixation System
- K213543 — NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health
- K213637 — JAZZ Solo sensor
- K213638 — Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003)
- K201764 — Infinity Acute Care System (IACS) Monitoring Solution
- K211949 — AirStrip ONE Web Client with Alarm Communication Management (ACM)
- K212034 — LOSPA TKR System
- K212329 — Plasma IQ
- K212466 — LVivo Seamless
- K213149 — VOCO Retraction Paste
- K213359 — SeaSpine WaveForm, C Interbody System
- K213371 — Disposable Medical Nitrile Examination Gloves (Model:XYS-001)
- K213530 — Nextra CH Cannulated Hammertoe System
- K210817 — C&B 5.0 Hybrid
- K211487 — MAF Guard
- K211629 — Infrared forehead thermometer LD-FT-100B
- K211898 — ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20
- K212075 — ShurFit Lumbar Interbody System
- K212524 — Anteralign Spinal System with Titan nanoLOCK Surface Technology
- K212573 — PicoLO Premium
- K212639 — Disposable Medical Nitrile Examination Gloves (Non sterile)
- K212983 — Injectable Root Canal Bioceramic Sealer
- K213156 — BD Nano 2nd Gen Pen Needle
- K211309 — endomina system
- K212302 — BAYLAB 3-Ply Surgical Mask (BEACON I)
- K212438 — Comfortpro
- K213303 — Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42
- K213512 — DERMABOND PRINEO Skin Closure System
- K211448 — Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses
- K211772 — PMW01 Procedure Mask Level 1
- K211804 — 3Delta Crown
- K212235 — Surgical Face Mask
- K212381 — VersaTap, VersaLat, DueLock, VersaTi, MiniTi
- K212548 — LUXEN CL Dental Liquid
- K212827 — Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs
- K212852 — Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle
- K213096 — Al-Rad Companion (Pulmonary)
- K213115 — CHENA-C Spacer System
- K211561 — INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)
- K212535 — Nitrile Powder Free Blue Examination Gloves, Non-Sterile
- DEN200005 — Klox Biophotonic LumiHeal System
- K201435 — Molecular Flow Simulations
- K210126 — Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%
- K210241 — ImplaStation
- K210916 — PVmed Contouring Software
- K211786 — Independent Corneal Viewing Chamber (IVC-21)
- K212219 — AHI System
- K212258 — Medline Cardiovascular Procedure Kit
- K212295 — 21HQ513D
- K212442 — Cydar EV (Series B) and Cydar EV Maps
- K212500 — ArtiSential Trocar
- K212807 — Surgical Masks
- K213067 — Solero Microwave Tissue Ablation (MTA) System and Accessories
- K213116 — Everyway Incontinence Stimulation System
- K213266 — Inspan ScrewLES Fusion System
- K213580 — Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length
- K202175 — OxyLight 2.0
- K203745 — AURORA Evacuator +Coag
- K211452 — Encevis
- K211721 — PS System
- K211773 — Single-use Surgical Mask
Data sourced from openFDA. This site is unofficial and independent of the FDA.