FDA 510(k) clearances — page 275
clearances on record, most recent first.
Clearances — page 275
27,401–27,500 of 176,542- 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
- K173559 — Barrx SB RFA Endoscopic Catheter
- K173866 — Stryker AIM Light Source and SafeLight cable
- K170234 — Endotracheal tube; Reinforced Endotracheal tube
- K171247 — epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test
- K171634 — Ortho System
- K172164 — PROPEL Device
- K173020 — OBA-MCP, Orthodontic Bracket Adhesive with MCP
- K173113 — Medline Disposable Electronic Thermometer Probe Cover
- K173479 — NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)
- K173582 — ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes
- K173730 — Kinsa QuickCare Thermometer
- K173820 — OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU)
- K173838 — ARIA Radiation Therapy Management
- K173884 — Unity Total Knee System
- K171556 — K2M Navigation Instruments
- K171761 — ACCLARENT AERA Eustachian Tube Balloon Dilation System
- K172189 — Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt
- K172384 — Quickie(r) Q700-UP M
- K172683 — Yamahachi Pink CAD/CAM Disk
- K172977 — Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel
- K173054 — Navigo Workstation Version 2.0
- K173240 — Arthrex PushLock
- K173622 — CS Imaging
- K173641 — Activ Ankle
- K171799 — Elos Accurate Customized Abutment, Elos Prosthetic Screw
- K171354 — MR4 Laser
- K163451 — Action Trackstander models TR1816, TR1820, TR2016, and TR2020
- K171148 — Aleo BME Liquid Bandage
- K171213 — One Touch Condom with Benzocaine
- K171292 — A7 Anesthesia System
- K171311 — A5 Anesthesia System
- K171411 — IRRIS (Infra-Red-Red Intubation System)
- K171498 — MSD CRP Assay Kit and MESO SECTOR S 700 Instrument
- K171625 — Single Lumen Ovum Aspiration Needles
- K171628 — HBS2 Headless Bone Screw
- K171958 — PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE
- K172287 — ipsogen JAK2 RGQ PCR Kit
- K172438 — ARBOR External Fixation System
- K172548 — Wiltrom Spinal Fixation System
- K172774 — T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System
- K172913 — cobas Factor II and Factor V Test
- K173291 — 6440 Ultrasound System
- K173504 — K-Y Silicone
- K173547 — ImagenUniversal
- K173560 — Microcatheter
- K173588 — Illumeo System
- K173602 — Optima XR240amx, AutoGrid
- K173635 — syngo.via RT Image Suite
- K173795 — HI-TORQUE TurnTrac Guide Wire Family
- K173828 — GU60A & GU60A-65
- K170421 — ET Hybrid Abutment
- K170748 — GLOBAL UNITE Platform Shoulder System
- K171122 — CEREC Ortho Software
- K171207 — FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M
- K171517 — Digital Electrocardiograph
- K171622 — Dentium Ti-Base
- K171665 — Microcatheter and guide-wire system
Data sourced from openFDA. This site is unofficial and independent of the FDA.