FDA 510(k) clearances — page 318
clearances on record, most recent first.
Clearances — page 318
31,701–31,800 of 175,699- K160623 — FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture
- K160647 — IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4
- K160900 — CapSure Fixation System - Straight 5mm x 37 cm 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm 15 Permanent fasteners
- K161209 — Cirona 6400
- K161246 — Ez3D-i / E3
- K161300 — Acclarix AX8 Diagnostic Ultrasound System
- K150044 — O-PEP
- K151781 — Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor
- K152167 — BIJOU Orthodontic Ceramic Bracket
- K152776 — Glocyte Automated Cell Counter System
- K152826 — NoCord
- K153149 — Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36
- K153736 — 3mensio Workstation
- K160305 — neoBLUE® LED Phototherapy System
- K161170 — BD Eclipse Hypodermic Needle
- K151540 — MC BIO Supertack Tack 3mm, 4mm and 5mm
- K152319 — Auris Robotic Endoscopy System (ARES)
- K152464 — ORAcollect.Dx
- K152535 — Z5 Slit lamp microscope, Z2 Slit lamp microscope
- K152556 — Oragene Dx
- K152571 — Stivax
- K152612 — eSensor Warfarin Sensitivity Saliva Test
- K152818 — Yongchang Powder-Free Yellow Vinyl Patient Examination Gloves
- K153379 — AxSOS 3Ti
- K160344 — Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olifilcon B) multifocal silicone hydrogel soft contact lenses, Si-Hy (olifilcon B) toric silicone hydrogel soft contact lens2/16/2016
- K160393 — AdTec
- K160501 — Noxilizer Surgical Ruler
- K160713 — Stealth-Midas System
- K160809 — Reveal LINQ
- K160902 — Mariner Pedicle Screw System
- K160980 — Threshold Pedicular Fixation System, Palisade Pedicular Fixation System
- K161167 — Seal Single-Use Biopsy Valve
- K161190 — G7 Dual Mobility System, Active Articulation System
- K161221 — Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug
- K161228 — Radiance Ultra Series ZeroWire Embedded
- K151784 — ActTrust
- K152789 — FLEX SCORING CATHETER
- K153026 — Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement
- K153345 — Stryker Orthopaedics Hip Systems Labeling Update
- K153477 — EMMa Electronic Monitoring Management
- K153582 — Prometheus ChitoGauze XR PRO
- K153629 — ArcadiusXP C Spinal System
- K153743 — PIEZOSURGERY PLUS
- K153762 — Smartdop XT6
- K160449 — Penumbra System, Penumbra Pump MAX
- K160570 — Creatine Kinase
- K153162 — Hypocore
- K160197 — Haemonetics Cell Saver Elite Autotransfusion System
- K160533 — Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)
- K161208 — CROSSER CTO Recanalization Catheter
- K150956 — PINPOINT Endoscopic Fluorescence Imaging System
- K152544 — Agem Ag Mesh Dressing with Silver
- K153099 — INCLUSIVE TAPERED IMPLANT SYSTEM
- K153597 — Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
- K161176 — ARTOURA Breast Tissue Expanders with Smooth Surface
- K151492 — Kudu
- K152103 — IPS Style Ceram, IPS Style Ceram One, IPS Style Press
- K152423 — Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy
- K152507 — Dr. Wolff Vagisan Moisturising Cream
- K152559 — TruAbutment DS
- K153127 — everX Posterior
- K153334 — Oral-B 5% Sodium Fluoride Varnish
- K153359 — BardPort®, SlimPort®, and X-Port® Implanted Ports
- K153650 — Microdent Ektos Implant System
- K160052 — CUR Model 1
- K160065 — GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System
- K160091 — Temperature Probe, Affinity Temperature Probe
- K160152 — Trillium Oval V 5.1 MRI System
- K160289 — MasterLoc Stem
- K160416 — CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes
- K160463 — Reliance Lumbar IBF System
- K160506 — Planmeca ProMax 3D Max, Planmeca Maximity
- K160810 — ViZion DR + Wireless
- K160877 — United Urologics Closed System Catheter
- K160889 — BIB Stent Placement Catheter
- K161123 — Baha 5 Power Sound Processor
- K161140 — VITROS Chemistry Products Calibrator Kit 3
- K150553 — Filbloc
- K152452 — Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200
- K152466 — Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)
- K152842 — WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL
- K153107 — Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine VEO Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System
- K153264 — EasyPass Guidewire
- K153658 — Target Detachable Coils
- K153778 — Nester Embolization Coils, Tornado Embolization Coils
- K160290 — Valleylab REM Polyhesive Infant Patient Return Electrode
- K160342 — EMPOWR PS Knee System
- K160403 — SmartStart Air/Water and Suction Valves
- K160537 — Navio
- K160994 — C2 CryoBalloon Focal Pear Catheter
- K161041 — OsteoMed ExtremiLOCK Wrist Plating System
- K161102 — Nanostim Introducer Kit
- K161125 — OptiCross X, 40 MHz Coronary Imaging Catheter
- K153663 — Vario 8/18/ci
- K160226 — JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector
- K160332 — Stryker SDC3 HD Information Management System with Wireless Device Control Capability
- K161229 — Mammo Tomosynthesis (MDMG-5221)
- K152062 — BIOFOAM Bone Wedge
- K152657 — SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens
- K153331 — SafeCT-29
Data sourced from openFDA. This site is unofficial and independent of the FDA.