FDA 510(k) clearances — page 224
clearances on record, most recent first.
Clearances — page 224
22,301–22,400 of 176,542- K182184 — Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted)
- K190319 — Waterlase Laser System Family
- K190386 — KTA Adipose Treatment Kit
- K190523 — Cranial PSI Accessory Anatomical Model Original, Cranial PSI Accessory Anatomical Model Modified, Cranial PSI Accessory Plastic Drawing Guide, Cranial PSI Accessory Cranial Implant Trial
- K190772 — SURGICAL MICROSCOPE SYSTEM ORBEYE with IR
- K191010 — Palladium High Flow Therapy System
- K191174 — Mercy babyTAPE
- K191417 — Belun Ring
- K191458 — Legacy SMARTBase Abutments
- K191659 — Instylla Delivery Kit
- K191963 — SMR Finned Short Stems
- K192147 — Halyard ONE-STEP* Sterilization Wrap
- K192210 — ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System
- K192465 — DigiFix Sterile Kit
- K192474 — VERA
- K192526 — Spine Wave Navigated Instruments
- K182448 — AnyRidge Octa 1 Implant System
- K190314 — Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000
- K190321 — Pediatric Nailing PlatformFemur
- K190630 — SolidAIRity III Airway Stabilization System
- K191359 — Nipro Syringe
- K191523 — Visalys Restorative Primer
- K191596 — Arcadia Balloon Catheter
- K191687 — pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire
- K191783 — Parcus Synd-EZ Ti
- K192185 — The Cellfina System
- K192200 — DynaCAD
- K192208 — CORNICE Cervical Spacer System
- K182773 — Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps
- K183171 — ScopeSeal Duodenoscope Protective Device
- K191127 — Advanced Intermezzo Implant System
- K191133 — KATANA Cleaner, KATANA Cleaner (Trial)
- K191150 — Bodycad Unicompartmental Knee System
- K191369 — TSolution One Total Knee Application
- K191448 — Barrier Sleeves
- K191779 — Attune Revision LPS Inserts
- K191854 — Premia Spine XL Instruments
- K192206 — 32mm Glenosphere and Humeral Cup
- K190086 — Cepheid Xpert Respiratory Control Panel
- K190538 — NIO-I
- K191431 — Interlude Rolled Tampons in Plastic Applicator
- K191632 — PROFEMUR TL2 Stems
- K191833 — Dexcom G6 Pro Continuous Glucose Monitoring System
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.