FDA 510(k) clearances — page 266
clearances on record, most recent first.
Clearances — page 266
26,501–26,600 of 175,699- K171396 — ODFS Pace XL
- K171772 — Ecosite Bulk Fill
- K172240 — SPI Dental Implant System
- K172567 — GORE Molding and Occlusion Balloon Catheter
- K172643 — da Vinci Xi Surgical System; da Vinci X Surgical System
- K172845 — Symetri Clear
- K173088 — Vitrea Software Toshiba Package VSTP-001A
- K173530 — Indego(R)
- K173601 — Merit Syringe
- K180010 — AtriClip FLEX-V
- K170438 — MiroCam Capsule Endoscope System
- K171500 — Uro-V Cystoscope
- K171835 — Irradiation Aesthetic Device
- K172159 — Getinge GSS67N Series Steam Sterilizer
- K173389 — Rex Medical Aspiration Pump
- K173417 — Zimmer Persona Personalized Knee System
- K173436 — Luma Light System
- K163081 — 40-42mm BiPolar Head and 22mm Femoral Head
- K173285 — JOULE SYSTEM
- K173596 — Rusch Intermittent Urethral Catheters
- K173814 — DeGen Medical E3 MIS Pedicle Screw System
- K162665 — MiCor A100 Wearable ECG Recorder
- K171367 — SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES)
- K171391 — Stryker 90-S Max SERFAS Energy Probe
- K172716 — V2K Rinspiration System
- K172816 — TiGer Shark System
- K172890 — SedLine Sedation Monitor
- K172896 — Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312
- K172935 — Embrace
- K172969 — Essence 55S Large Monitor System
- K173299 — DRAGON X SPSL4HC, DRAGON X SPSL8HC
- K173382 — Vantage Galan 3T, V4.6
- K173430 — SeQure® NF and SeQure® Microcatheters
- K173466 — Panthera Dental Milled Bars
- K173558 — SyMRI
- K173709 — Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm
- K173843 — illumiflow 148 Laser Cap
- K173932 — Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2
- K173953 — uDR 780i
- K173955 — Mic-Key* SF Over-the-Wire Stoma Measuring Device
- K171264 — Royal Flush Catheter
- K171954 — ClearLine IV
- K171968 — EchoGlo Needle
- K171971 — Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer
- K172116 — Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)
- K173060 — F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version
- K173062 — Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))
- K173448 — CliniCloud Stethoscope
- K173542 — Arterys Oncology DL
- K173581 — Gallant PTCA Dilatation Catheter
- K171528 — Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5)
- K171942 — Electrocardiograph
- K173196 — SUNTOUCH Dental Dressing
- K173363 — Cycler Drain Bag Set
- K173521 — SeaSpine Cabo ACP (Anterior Cervical Plate) System
- K173876 — Cybird LED Curing Light
- K163684 — C2 CryoBalloon Ablation System
- K171789 — ARROW Reverse Porous Glenoid
- K172304 — TruAbutment DS
- K173442 — gammaCore-S
- K163600 — Kit Boxes and Kit Plates
- K171312 — FortiCore®
- K171360 — CONTEC Electrocardiograph
- K172920 — 3D APT
- K173217 — CAMPYLOBACTER QUIK CHEK
- K173219 — CAMPYLOBACTER CHEK
- K173235 — Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile
- K173306 — EZ Plate
- K173584 — 3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader
- K180025 — Centurion POCT System
- K171228 — Fiji Anchor
- K171273 — LINK® BiMobile(TM) Dual Mobility System
- K171291 — FUJIFILM Bronchoscope Model EB-530P
- K171313 — EM-4000 Specular Microscope
- K171673 — Focus Cap
- K171674 — Angel Align System
- K171731 — KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
- K171784 — Straumann Dental Implant System
- K171827 — ReddyPort NIV Access Elbow
- K172696 — FORZA® XP Expandable Spacer System
- K173119 — DRI OCT Triton
- K173215 — Choice Spine Laminoplasty Fixation System
- K173283 — Reliance Lumbar IBF System
- K173301 — BioSphere MIS Putty (BioSphere MIS)
- K173478 — OnSight 3D Extremity System
- K173554 — PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope
- K173616 — DIP Arthrodesis System
- K173875 — GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert
- K173878 — PreXion3D Excelsior
- K173891 — Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume
- K163288 — Pelvifine Pelvic Muscle Trainer
- K171237 — FMS VUE II Fluid Management and Tissue Debridement System
- K172259 — PulsioFlex Monitoring System
- K172319 — AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System
- K172575 — BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap
- K172791 — Lumilisse IPL Hair Remover
- K172796 — Flex Robotic System and Flex Transabdominal Drive
- K172962 — Nurture Rest
- K173338 — Navigated INFINITY Instruments
- K173476 — Tritanium® TL Curved Posterior Lumbar Cage
Data sourced from openFDA. This site is unofficial and independent of the FDA.