FDA 510(k) clearances — page 324
clearances on record, most recent first.
Clearances — page 324
32,301–32,400 of 175,699- K153238 — Dignity Dual Port
- K153335 — AlertWatch: OR
- K153584 — NeoTract UroLift System UL500
- K153612 — ArthrexVIP Web Portal
- K153633 — Endoform Reconstructive Template
- K160114 — Xspan Laminoplasty Fixation System
- K160409 — AOS Anterolateral Proximal Humeral Plate
- K160457 — FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch
- K152530 — UCP Stem
- K152845 — Allied Biocompat Abutment for Nobel Replace Interface
- K153027 — Cryotop US
- K153041 — Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling
- K153119 — Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Medical FRS Digital Radiography System,
- K153153 — Reprocessed Electrophysiology Catheter
- K153412 — Sleep Profiler
- K153661 — ImmunoCard STAT! HpSA
- K153754 — MicroMatrix
- K160145 — Full Automatic (NIBP) Blood Pressure Monitor
- K151271 — BellaFuse
- K151506 — Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula
- K151559 — ImmuLisa Enhanced Centromere Antibody ELISA
- K151688 — chromID MRSA
- K151748 — Clean & More
- K151780 — CAAS Workstation
- K151965 — Dentti System
- K152178 — StimQ Peripheral Nerve Stimulator (PNS) System
- K152394 — Rapicide PA High-Level Disinfectant Test Strips
- K152646 — SYLK PERSONAL LUBRICANT
- K160064 — MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System
- K160374 — 20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System
- K160389 — NovaCross Microcatheter
- K160662 — Surefire Infusion System
- K142993 — QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument
- K151421 — Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines
- K151940 — Thora-3Di, Model T-01
- K151984 — Thommen Milling Abutment for CAD/CAM
- K152217 — Exactech Vantage Total Ankle System
- K152720 — Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color
- K152919 — OMNI Skirted Heads
- K153090 — Reprocessed Diagnostic Ultrasound Catheter
- K153248 — PEEK Customized Cranial Implant
- K153485 — ENROUTE Transcarotid Neuroprotection System
- K153776 — Optetrak One Logic Femoral Components
- K160069 — Sonoma Fibula Repair System
- K160078 — Vivid T8
- K160369 — GuideWire
- K160386 — ReadeR, VieweR, QuickScan PSP
- K151694 — Gammex PI Hybrid Surgical Gloves
- K152448 — da Vinci Single-Site Instrument and Accessories
- K152625 — MMS Guide Catheter
- K152662 — S-Wire
- K152712 — Nitrile Powder Free Patient Examination Gloves, Blue Color
- K153429 — SmartView 3D Option
- K153671 — Family of CoolGlide Aesthetic Lasers
- K160002 — Piccolo Composite(R) Distal Volar Radius Plate System
- K160058 — Biomet Variable Pitch Compression Screw System
- K160381 — TE7 Diagnostic Ultrasound System
- K152206 — SurgiPure XD Reconstructive Tissue Matrix
- K152262 — Ventix Knotless Anchors
- K152766 — CharmFlex
- K152815 — Mailuokang Self-adhesive Electrode
- K152882 — Propeller System
- K153270 — TruGuard Custom Tongue and Jaw Positioner
- K153326 — Erisma-LP Spinal Fixation System
- K160085 — Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System
- K150731 — Medline Epidural Catheter
- K150876 — Bead Block
- K152614 — Xpert Carba-R
- K152824 — MEDT PEN NEEDLE
- K152835 — URITEK TC-201 URINE CHEMISTRY TEST SYSTEM
- K153244 — Cios Fusion
- K153400 — ProLift Expandable System
- K153430 — Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select
- K160025 — iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System
- K160041 — Cobbra RF Tissue Dissector
- K160418 — PERIMETER Interbody Fusion Device
- K150144 — VisuCon-F Low Fibrinogen Control Plasma
- DEN140017 — SENSIMED TRIGGERFISH
- K151136 — HARMONIC HOOK
- K151590 — Straumann RN Gold Abutment for Bridge
- K151597 — Family of Steam Sterilizers B 28 series
- K151789 — LOCATOR F-Tx Attachment System
- K151847 — SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens
- K152238 — Sun Capsule 60/160/1.8/6, Sun Capsule 60/220/1.9/6, Sun Capsule 60/225/2.0/6, Sun Capsule 54/225/2.0/5.5, Sun Capsule 54/200/1.8/6, Sun Capsule 54/160/1.8/6, Sun Capsule 49/225/2.0/5.5, Sun Capsule 49/220/1.9/5.5, Sun Capsule 48/220/1.9/6, Sun Capsule 48/200/1.86, Sun Capsule 48/180/1.9/6, Sun Capsule 48/160/1.8/6, Sun Capsule 44/180/2.0/5.5, Sun Capsule 44/180/1.9/5.5, Sun Capsule 39/180/1.9/5.5
- K152249 — ASAHI Corsair Armet
- K152402 — IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU)
- K152421 — IS4000 Stapler 30 Instrument and Stapler 30 Reloads
- K152482 — Propeller Sensor Model 2014-R
- K152547 — DNAP Electrode
- K152861 — Aquasil Ultra + Smart Wetting Impression Material
- K152897 — Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory
- K152957 — MultiCross Catheter
- K153212 — Sheathes Ultrasound Probe Covers
- K153346 — syngo Application Software VD11
- K153513 — Insufflator 50L FM134
- K160237 — Cefaly
- K160257 — PROTEK Duo 31 Fr. Veno-Venous Cannula Set
- K160272 — Endophys Pressure Sensing Sheath Kit
- K160301 — Platinum dRF Imaging System
- K160426 — syngo.via MI Workflows
Data sourced from openFDA. This site is unofficial and independent of the FDA.