FDA 510(k) clearances — page 216
clearances on record, most recent first.
Clearances — page 216
21,501–21,600 of 175,699- K192428 — AFX Femoral Implant with Inserter
- K183441 — Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs
- K183710 — Vivio System
- K190060 — Urethrotech UCD
- K190183 — Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe
- K190298 — DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12
- K190591 — Safergel Sterile Ultrasound Gel
- K190940 — Tokuyama Rebase III
- K191713 — CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield (ROI Assembly)
- K191843 — Ceramill A-Temp
- K191994 — ProFound AI Software V2.1
- K192005 — Bausch + Lomb PreVue Inserter for enVista Preloaded
- K192128 — Sutter Arrowtip Monopolar Electrodes
- K192422 — Steerable Introducer 12F
- K192433 — LZI Methadone II Enzyme Immunoassay
- K192448 — Delta Xtend Revers Shoulder System
- K182143 — ALFA GATE Dental Implants System
- K183479 — Asthma Monitor AM3
- K190179 — SAHARA Stabilization System
- K190208 — Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe
- K191066 — CD Horizon Astute Spinal System
- K191099 — Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel
- K191332 — XACT Robotic System
- K191344 — Arthrex Mini Comprehensive Fixation System 2.0mm & 2.4mm Module
- K191490 — Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe
- K191794 — Vintage Art Universal
- K191806 — Propex IQ Apex Locator
- K191993 — Yumizen C1200 CRP
- K192318 — Ultraverse 014 and 018 PTA Balloon Dilatation Catheters
- K192398 — Millenium HX
- K192400 — EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG
- K192424 — Mobius3D
- K192427 — Ablation Confirmation
- K190820 — Aimanfun Lumea Comfort
- K191363 — Neocis Planning Software Application (NPSA) for 3rd Party PCs
- K191397 — OxySoft (olifilcon C) silicone hydrogel soft contact lens
- K191889 — NG-Test CARBA 5
- K191932 — Momentum Posterior Spinal Fixation System
- K192064 — LIAISON Vitamin B12
- K183462 — Applied Biosystems Bacillus anthracis Detection Kit
- K191507 — Intellijoint® Navigation System
- K191526 — Cardioblate CryoFlex Surgical Ablation System
- K191610 — RTapp
- K191958 — Aveta System
- K192303 — ExactVu High Resolution Micro-Ultrasound System
- K192416 — BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System
- K192426 — Signa Voyager, Signa Voyager Quantum
- K192453 — DIAMOND-5A/6A/8A
- K190048 — UF(II) Anatomic abutment
- K191774 — SmileAlign Orthodontic Aligner System
- K191844 — Fidmi Low Profile Enteral Feeding Device
- K191848 — APTUS Wrist Spanning Plates 2.5
- K192425 — Hair Boom 69, Hair Boom Air, Ulike Hair UpUp
- K191524 — Visalys Tooth Primer
- K180001 — Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant
- K181606 — Precision Spine Navigation Instrumentation
- K182722 — XLR8 Abdominal Wound Dressing Kit
- K190024 — Smart-C
- K190059 — CEREC Guides
- K190076 — Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems
- K191074 — Sorrento Bone Graft Substitute
- K191444 — Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir
- K191521 — Radiance 330 Proton Beam Therapy System
- K191747 — FUJIFILM Duodenoscope Model ED-580XT
- K192050 — ETEST Eravacycline (ERV) (0.002 32 µg/mL)
- K192112 — FlexBand Plus
- K192129 — ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens
- K192352 — MiniMAX
- K192368 — CATSmart
- K192421 — EpiFaith Syringe
- K182009 — Dia-Proseal
- K190029 — Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar
- K190199 — SepaSperm Washing Solution, SepaSperm Solution
- K190454 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue) - Extended Cuff
- K190466 — PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate
- K191336 — PRECICE System
- K191530 — StoneChecker
- K191537 — eCarbon IBDs
- K191545 — Exogenesis Hernia Mesh
- K191748 — Genesys Spine Sacroiliac Joint Fusion System
- K192195 — Sterile Dilator
- K192364 — GXR-Series Diagnostic X-Ray System
- K192371 — BioZorb SP Marker
- K192391 — Spectralis HRA+OCT and Variants
- K192435 — NuVasive NuvaLine
- K183190 — NuStat
- K183675 — 3D Visualization System
- K183687 — LifeWindow LW8 Lite
- K190022 — SafeBreath Filter Mouthpiece
- K190323 — Aloe Glide Lubricant
- K190536 — Mediracer NCS
- K190875 — EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)
- K191742 — ARIES MRSA Assay
- K191765 — OMNI TiN Coated Apex Knee System
- K191791 — TranS1 Interbody Fusion System
- K192011 — PhoeniX
- K192102 — Thermoplastic Masks
- K183391 — Novidia Universal Bond
- K190574 — Patient Assistant Model PA97000
- K191006 — EasiSlush
Data sourced from openFDA. This site is unofficial and independent of the FDA.