FDA 510(k) clearances — page 259
clearances on record, most recent first.
Clearances — page 259
25,801–25,900 of 176,542- K180958 — Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable
- K181268 — PROLENE (Polypropylene) 3D Patch
- K181401 — RxSight Insertion Device
- K181579 — eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K
- K181659 — Avologi ENEO
- K181699 — Level 1 Convective Warmer
- K181706 — neuromate Gen III
- K181712 — San Antonio Stopcock
- K181790 — CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
- K181855 — RadialSeal Introducer Kit
- K173837 — RHYTHMIA HDx Mapping System (with software Version 2.0)
- K173947 — Lumbar Interbody Fusion System (OLLIF)
- K180226 — TREND II Spinal Fixation System- STEP Series
- K180407 — Smartinhaler
- K180632 — Exactech Equinoxe Small Reverse Shoulder System
- K180752 — Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole
- K180960 — FIXIT / ComposiTCP Threaded Anchor System
- K181453 — ATEC ALIF Spacer System
- K181495 — Republic Spine Dark Star Spinal System
- K181670 — Alphenix, INFX-8000V/B, V8.0
- K172095 — Autokeeper
- K172862 — Portable ECG Monitor (ECG3)
- K173929 — CipherOx CRI M1
- K173943 — Dental High-speed Handpiece and Accessories
- K180017 — MX40 Release C.01
- K180115 — TWBM Pump
- K180218 — Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
- K180544 — DePuy Synthes Static Staples
- K181025 — I-Portal Neuro Otologic Test Center +2 more
- K181095 — RF-Relief
- K181178 — S-mini active Fixture
- K181339 — Altus Spine Pedicle Screw System
- K181399 — FIREFLY® Pedicle Screw Navigation Guide
- K181686 — CELERITY 20 Steam Biological Indicator
- K171888 — Non-contact infrared body thermometer
- K173444 — Quantitative Total Extensible Imaging (QTxI)
- K173645 — JASPER Spinal Fixation System
- K180518 — GME LinScan Lite 808 Laser System
- K180854 — Voyager Trajectory Array Guide (V-TAG)
- K181083 — Stryker All-PEEK Knotless Anchor System
- K181242 — Braun BNT400 No Touch + Forehead Thermometer
- K181398 — DV-300 Aspirator
- DEN170009 — Bonebridge
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.