FDA 510(k) clearances — page 350
clearances on record, most recent first.
Clearances — page 350
34,901–35,000 of 175,770- K143462 — AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)
- K143531 — Rapid Therapy System
- K143606 — MultiBand SENSE
- K150138 — Aspen Laser Systems Therapy Laser System
- K150213 — Subtalar Spacer System (STS)
- K150217 — ORTHOPHOS SL
- K150333 — MedSource Sharps Dart
- K150342 — Touch Ultrasound
- K150530 — Level Sensor, Level Sensor Tape
- K150620 — 740 SELECT
- K150636 — VariSeed 9.0
- K150706 — VitalBeam
- K150772 — Snap-Off Self-Compressive Screw
- K150816 — Jumong Series
- K150946 — FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm x 12mm x 80cm, FLASH Ostial System OTW-7.0mm x 12mm x 135cm
- K151007 — 21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550)
- K142032 — MRI PATIENT MONITORING SYSTEM TESLA M3
- K142192 — Insightra Freedom Ventral Hernia Repair System
- K142482 — The Vest Airway Clearance System
- K142487 — Chesapeake Stabilization System
- K142717 — Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye Contact Lens Case
- K142744 — Mecta-C TiPEEK
- K143147 — Gemini Bonded Sterilization Wrap
- K143185 — entré Model PD08-U
- K143467 — FORA GD43 Blood Glucose Monitoring System
- K143667 — GC KommonBase
- K143750 — MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System
- K143759 — JAZZ System
- K150036 — Blue Mountain Cervical Plate System
- K150267 — QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators
- K150359 — Tensyn Plug
- K150663 — Diagnostic X-ray System
- K150954 — Elite L Expandable Lumbar Fusion System
- K143434 — One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series
- K143585 — Electric Breast Pump
- K150056 — Luxisse+
- K150281 — StatStrip Glucose Hospital Meter
- K150389 — Spiral Flow Peripheral Vascular Graft
- K150999 — Acclarix Diagnostic Ultrasound System
- K141875 — Pasture 60S Surgical Mask
- K142568 — Stryker MEDPOR TITAN 3D Orbital Floor Implant
- K150237 — ILUMIEN, Drageonfly OPTIS Imaging Catheter
- K150536 — Terumo Circuit Tubing
- K141576 — Maxima PRO 45L
- K141910 — Intraosseous Cannula System Bio-MAC¿ and Bio-CORE
- K142038 — EUROIMMUN LYME ELISA(IgG/IgM)
- K143608 — NovaCross Microcatheter
- K143714 — Powerheart G5 AED
- K150007 — Modified Bencox Hip System
- K151041 — ERBECRYO 2 Cryosurgical Unit with accessories
- K143734 — Digital Automatic Blood Pressure Monitor BPM28 Series - MD2800, MD2810
- K150055 — OneStep Pediatric CPR Multi-Function Electrode
- K150198 — CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel
- K141036 — BGM009 BLOOD GLUCOSE MONITORING SYSTEM
- K141146 — INVISIPORT
- K142087 — COVA MONITORING SYSTEM
- K142162 — MERITS TRANSFORMER POWER SCOOTER, S941
- K142212 — Pyrenees Cervical Plate System
- K142469 — 2D Mercy TAPE & 3D Mercy TAPE
- K143101 — Helio A7 Manual Wheelchair, Move Manual Wheelchair
- K143212 — Bifix Temp
- K143448 — Sonendo GentleWave System
- K143528 — Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System
- K143540 — Stryker MIS Attachments and Cutting Accessories
- K143679 — Nuance FLOW
- K150035 — V10 system
- K150243 — Invictus Medical GelShield
- K150403 — ADVIA Centaur TSH3-Ultra
- K150522 — G7 Dual Mobility System
- K150542 — Terumo Pump Tubing
- K150615 — Vaginal Moisturizing Gel
- K150626 — Rush Medullary Pins
- K150797 — Digital Dental Intra Oral Sensor, EzSensor Smart
- K150818 — Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System
- K150880 — Tablo Console with Wireless Capability
- K150891 — BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System
- K150955 — Elecsys Progesterone III Cal Check 5
- K142646 — XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and
- K142820 — BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, BIOLENS Toric (mangofilcon A) Soft (hydrophilie) Contact Lens for Daily Wear, BIOLENS Multifocal (mangofilcon A) Soft (hydrophilic) contact lens for daily wear, BIOLENS Toric Multifocal (mangofilcon A) Soft (hydrophilic) contact lens for daily wear
- K142964 — VALIDATE Anemia Calibration Verification/ Linearity Test Kit
- K143272 — ApneaLink Air
- K150256 — SILVERLON BURN CONTACT DRESSINGS
- K150330 — Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)
- K150361 — ViSi Mobile Monitoring System
- K150385 — NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
- K150649 — G3 Active Plate Large Fragment System
- K150813 — iTClamp50
- K150913 — INCITE ANCHORED CERVICAL INTERBODY DEVICE
- K151013 — Vitaphone Tele ECG Loop Recorder
- K141984 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
- K142073 — ST'RIM
- K142153 — HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML
- K142392 — Zavation Posterior LEIF
- K142839 — GenCut Core Biopsy System
- K142867 — Reliance Posterior Cervical-Thoracic System
- K142979 — RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft Port; Gauze NPWT Wound Dressing Kits with Soft Port; EZ PLUS/EZ MAX Canisters
- K143351 — iCase Contact Lens Case
- K143595 — NuVasive(R) CCX-L Interbody System
- K150188 — SMV Scientific 4.5 mm Bone Screws
- K150252 — PHALINX Hammertoe System
Data sourced from openFDA. This site is unofficial and independent of the FDA.