FDA 510(k) clearances — page 251
clearances on record, most recent first.
Clearances — page 251
25,001–25,100 of 175,699- K173188 — The Graft Natural Bone Substitute
- K173366 — NicoletOne
- K173675 — AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber
- K173973 — TV-100
- K180022 — Athena Cervical Plate System
- K180263 — EcoFit Vit E Acetabular System
- K180864 — WATCHMAN TruSeal Access System
- K180948 — TruDi NAV Suction Instruments
- K181017 — Free Testosterone AccuBind ELISA Test System
- K181382 — GuardianTM Burr Hole Cover System
- K181585 — JGH1 Core Deccompression Procedure Kit
- K181626 — Digital Diagnostic Mobile X-ray System
- K181629 — GC85A
- K181631 — GR40CW
- K181636 — Aurora
- K181647 — Bandit guidewire
- K170369 — Disposable Electrosurgical Pencils
- K171566 — Atellica IM High-Sensitivity Troponin I (TNIH)
- K172857 — Latitud Hip Replacement System
- K173585 — da Vinci Xi Surgical System, da Vinci X Surgical System
- K173911 — Medline Burn and Wound Dressing
- K180419 — Ultrasonic Doppler (Model YM-2T8)
- K180629 — DentiqGuide
- K180763 — CuffLink Implant System Biocomposite
- K181342 — JGH1 Bone Graft Substitute
- K181345 — Image Filing Software NAVIS-EX
- K181623 — Clarifi Imaging System
- K181834 — Ultimax-i, DREX-UI80 (V1.60)
- K170820 — Capnograph and Oximeter
- K171011 — PENTAX Medical VIVIDEO ENT Videoscope Solution
- K172389 — ePTFE-Coated Auricular Implant
- K172653 — Power Infuser
- K173327 — DIP/U.S. Urine Analysis Test System
- K173487 — CarboClear® Pedicle Screw System
- K173762 — AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters
- K173829 — NeoLSD MSMS kit
- K180027 — ACCUSYTE 3D Fiducial Marker
- K180784 — ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES
- K180977 — KARL STORZ New Generation Trocars
- K181014 — Tritanium PL Cage
- K181015 — Braun BFH175 Infrared Forehead Thermometer
- K181062 — Ultra Facial Toning System
- K181079 — SeaSpine Regatta Lateral System
- K181189 — ATLANTIS Conus Structure
- K181376 — ARIETTA 65
- K171272 — Cook-Swartz Doppler Flow Probe
- K173654 — Ureteral Dilator Sets, Ureteral Dilators
- K173797 — Stat Profile Prime Plus Analyzer System
- K173968 — Straumann Variobase for Bridge/Bar Cylindrical
- K180269 — Cadwell Apollo System
- K180348 — Field Orthopaedics Micro Screw System
- K180915 — Sonicision Reusable Sterilization Tray
- K181030 — Rubicon Lumbar Interbody Fusion System
- K181375 — Apex Femoral Nailing System
- K180151 — MC3 Jugular Dual Lumen Catheter
- K180526 — EIDON FA
- K180534 — Philips IntelliVue GuardianSoftware
- K181002 — Atellica IM BRAHMS Procalcitonin (PCT)
- K181016 — Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System
- K181019 — Diode Laser System
- K181115 — CxHA PEEK Cervical IBF System
- K181300 — Embosphere Microspheres
- K181600 — PathLoc-SI Joint Fusion System
- K181029 — Solana Bordetella Complete Assay
- K171550 — Sterile Latex Surgical Gloves, Powder Free
- K171880 — IRRAflow CNS System
- K172440 — Solax Electric Scooter, Models: S302121, S302131, S302141, S302151
- K172987 — Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001)
- K173340 — Yikang Latex Foley Catheter
- K173556 — Injection Screw
- K173909 — Dimension Hemoglobin A1c Assay
- K180011 — Pulmonx Chartis Tablet Console
- K180654 — PINXEL-RF system
- K180655 — Viking Lumbar Polyaxial Screw System
- K180673 — Normandy VBR System
- K181063 — Kestrel Buttress Plate System
- K181134 — GUM HYDRAL Dry Mouth Oral Gel, GUM HYDRAL Dry Mouth Oral Rinse, GUM HYDRAL Dry Mouth Oral Spray
- K181556 — EliA M2 Immunoassay
- K181565 — Aquarius 8600 Digital Radiography Sensor
- K181586 — Tinnitus Sound Generator Module
- K171274 — ADVIA Centaur High-Sensitivity Troponin I (TNIH)
- K172874 — Infrared Thermometer
- K173206 — SEKURE HbA1c Assay
- K173511 — ActiveCare TD-4121 Blood Glucose Monitoring System
- K173627 — Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector
- K180552 — Modified Novy Cornual Cannulation Set
- K180575 — THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type X
- K180613 — Estelite Universal Flow
- K180695 — FBC 921 (ALIF)
- K181011 — AIM2
- K181043 — StatStrip Glucose Hospital Meter System
- K181276 — CONOD Enteral Feeding Sets
- K181287 — Catalyst CSR Shoulder System
- K172543 — High-speed Turbine Handpieces for Single Use
- K173486 — NTU-USB Ultrasound USB Box
- K173631 — Intelli-C
- K173801 — Transcranial Doppler Ultrasound System
- K173881 — Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G
- K173969 — Medicalgorithmics Unified Cardiac Rehabilitation System
- K180024 — SALVATION Midfoot Nail
Data sourced from openFDA. This site is unofficial and independent of the FDA.