FDA 510(k) clearances — page 358
clearances on record, most recent first.
Clearances — page 358
35,701–35,800 of 176,542- 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 +4 more
- K143351 — iCase Contact Lens Case
- K143595 — NuVasive(R) CCX-L Interbody System
- K150188 — SMV Scientific 4.5 mm Bone Screws
- K150252 — PHALINX Hammertoe System
- K150283 — Republic Spine Dark Star Spinal System
- K150456 — Arthrex Plates, Screws, and Staples
- K150520 — DARCO Locking Bone Plate System
- K150579 — Cardinal Health External Fixation System
- K150633 — ULTRA Telescopes
- K150836 — OUTBACK Elite Re-Entry Catheter
- K150837 — IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps
- K150974 — aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping, Titanium
- K142196 — Visage Ease Pro
- K143024 — CAS-One Liver
- K143551 — Compex Wireless USA
- K150045 — S30/S40 Digital Color Doppler Ultraound System
- K150059 — BD FlowSmart Set
- K150223 — Facet-Link Stabilization Platform
- K150254 — Streamline OCT Occipito-Cervico-Thoracic System
- K150460 — KYPHON (R) HV-R(R) Bone Cement
- K150842 — JUSHA-M53 Medical Display
- K150286 — Medline Enteral Feeding Sets
- K141482 — KI-20
- K141643 — YARLAP
- K142061 — SILHOUETTE INSTALIFT
- K142371 — Luminesse PMMA
- K142624 — Neuromaster G1 MEE200
- K142909 — Flexible 19G EBUS Needle
- K142918 — EndoTool SubQ
- K143238 — C3 Wave
- K143530 — Aespire View
- K143741 — Lipofina Laser System
Data sourced from openFDA. This site is unofficial and independent of the FDA.