FDA 510(k) clearances — page 326
clearances on record, most recent first.
Clearances — page 326
32,501–32,600 of 176,542- K153131 — Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner
- K153164 — LunulaLaser
- K153518 — Medipure Oxygen-LC System
- K153611 — Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device
- K153704 — Strive
- K153719 — LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream
- K160115 — Heat Pain Pro
- K160427 — dynaMX(TM) Nitinol Compression Screw
- K160617 — Large Screws Range
- K160652 — iFUSE Implant System
- K160655 — OrthoButton CL
- K160668 — HumaPen Savvio
- K160775 — Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems
- K160905 — Sonendo GentleWave System
- K161183 — Halo One Thin-Walled Guiding Sheath
- K151229 — ABC D-FLEX PROBE
- K152519 — MTR550 (Tentative) Antimicrobial Silver Wound Gel
- K152576 — Anker II Dental Implant System
- K152856 — Helios III
- K152918 — Gun Oil, Pink, Gun Oil H2O, Pink Water
- K153036 — NobelDesign Software
- K153280 — PowerGlide Pro Midline Catheter
- K153606 — LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler, Tablet Application
- K160012 — O-pel Laser and families of probe delivery devices
- K160099 — CEREC SpeedGlaze
- K160119 — NobelSpeedy Groovy
- K160244 — VARIOunite
- K161193 — 16ch Tx/Rx Knee SPEEDER
- K151987 — DCI Edge Dental Chair with Operative Unit
- K152458 — Gemini Bonded Sterilization Wrap
- K152635 — QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls
- K153056 — Hermes Medical Imaging Suite v5.6
- K153165 — NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit
- K153288 — Voyant Open Fusion Device
- K153552 — AGE Automatic Upper Arm Blood Pressure Monitor
- K160264 — Additive Orthopaedics Hammertoe Correction System
- K160485 — VERIFY VH2O2 Indicator Tape
- K160552 — EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform
- K160573 — FirstSense Breast Exam
- K160870 — Hospira Administration Sets
- K150979 — CT/MR Compatible M.A.C. Interstitial GYN Template
- K152340 — NAR Sharps Shuttle; NAR Sharps Shuttle Pack of six
- K152583 — KARL STORZ Endoscopic ICG Imaging System
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.