FDA 510(k) clearances — page 279
clearances on record, most recent first.
Clearances — page 279
27,801–27,900 of 176,542- K173153 — Vertera Spine Coalesce Thoracolumbar Interbody Fusion System
- K171447 — OxyPure Color Silicone Hydrogel Soft Contact Lenses
- K172529 — Vivaer ARC Stylus
- K172561 — Disposable Circular Stapler
- K172618 — SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1
- K172707 — Renamel Microfill
- K172993 — P20 Series Digital Color Doppler Ultrasound System
- K173126 — Arisstos Spinal System
- K171771 — ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay
- K172085 — PhotoFix Decellularized Bovine Pericardium
- K172419 — Velofix TLIF Cage
- K172629 — Panther Fusion AdV/hMPV/RV Assay
- K172876 — PowerDot PD-01M
- K173260 — SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica +2 more
- K173470 — ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath
- K173538 — Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
- K170392 — S.I.N. Implant System
- K170553 — Altus Spine Interbody Fusion System
- K171185 — IR Type Implant System
- K171352 — EZFluence
- K171773 — Straumann n!ce Glass Ceramic A14 Blocks
- K171935 — Alevicyn SG Antimicrobial Gel
- K172008 — ARIX Humerus System
- K172255 — MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL)
- K172503 — MR Conditional Cup Electrode, MR Conditional Webb Electrode
- K172666 — CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor
- K172819 — LightWalker Laser System Family
- K172931 — DUS-6000 Digital Ultrasonic Diagnostic Imaging System
- K173038 — CuRAS Nd:YAG Laser
- K173058 — P10 Series Digital Color Doppler Ultrasound System
- K173129 — PRECICE System
- K173148 — ACIF
- K173209 — Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam in the Dilution Range of 0.008/8 - 18/8 ug/mL
- K173266 — Octane aspiration system
- K162718 — Foot Drop System (Model XFT-2001D)
- K170868 — FIXIT Threaded Anchor System
- K171571 — NexSite HD, Hemodialysis Step Tip Catheter (60cm)
- K171578 — Infrared thermometer
- K171934 — Birmingham Hip (BH) Dual Mobility Insert
- K172225 — Atlantis Abutment for MIS Implant
- K172469 — TiLock Modular Spinal System
- K172538 — Disposable Linear Stapler, Disposable Linear Cutter
- K172637 — HeRO Graft
- K172767 — Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid
- K172769 — CryOmega Flexx
- K172925 — Contact Lens Case, Model: A-1, B-1
- K172936 — Destiknee Total Knee System
- K173099 — Fortis and Hana Anterior Cervical Plate System
- K173233 — ReliefBand 1.5
- K173385 — Graft Delivery, DePuy Synthes
- K173399 — Endophys Pressure Sensing Sheath Kit- 8F
- K173522 — Solanas® Posterior Stabilization System
- DEN170041 — GeneSTAT.MDx Coccidioides Assay
- K170235 — Lucent®
- K170634 — Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power Scooter 5350
- K170690 — M-Vizion Femoral Revision System
- K171350 — Collision Check
- K171466 — NobelDesign, DTX Studio Design
- K171694 — s-Clean TiN Coating Abutments
- K171803 — HIVOX OTC Electrical Stimulator
- K172019 — Brisbane ALIF Device, Gladstone ALIF Device
- K172020 — Arlington PLIF/TLIF Cage
- K172067 — One Mum Pumpset
- K172491 — ICONN Square 2.5MM Suture Anchor
- K172689 — DESCRIBE PFD Patch
- K172771 — Epic Pro 940
- K172794 — Suction Irrigation Set
- K161652 — DIAZIR
- K170053 — Meridian PM
- K170688 — PITStop® implant
- K170916 — Portable Nebulizer
- K171226 — TOKUYAMA UNIVERSAL BOND
- K172642 — Orange Non Sterile Powder Free Nitrile Examination Gloves
- K173006 — Cefaly Dual
- K173111 — LAP-iX Suction Irrigation
- K173121 — Ankle Fusion Plating System
- K173290 — DuoFLEX Coil Suite
- K173377 — 3.0T 16ch Breast Coil
- K161855 — LED Curing Light
- K170811 — Single Use Retrieval Nitinol Basket V
- K171114 — HEALIX ADVANCE KNOTLESS Anchor
- K171488 — PSLT for PASCAL Streamline
- K171757 — Straumann Screw Retained Abutments
- K172030 — Devon 51
- K172300 — CoLink View Plating System
- K172603 — Cerafix Dura Substitute
- K172687 — Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
- K173089 — Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions
- K173135 — VariAx 2 System
- DEN170017 — FilmArray Respiratory Panel 2 plus (RP2plus)
- K170578 — True Function Adjustable Herbst Appliances
- K170946 — Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant
- K170959 — DIXI Medical Microdeep Depth Electrode
- K172292 — SALUS - Hygiene Instrument Reprocessing Container
- K172497 — NuVasive AttraX Scaffold
- K172678 — THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE
- K173171 — FilmArray RP2/RP2plus Control Panel
- K173372 — ExactechGPS Total Shoulder Application
- K170662 — Non Contact Infrared Forehead Thermometer
- K170666 — The Wrist-Type Fully Automatic Digital Blood Pressure Monitors
Data sourced from openFDA. This site is unofficial and independent of the FDA.