FDA 510(k) clearances — page 269
clearances on record, most recent first.
Clearances — page 269
26,801–26,900 of 175,699- K170950 — Well-Root ST
- K170972 — Apex Tibial Nailing System
- K171275 — Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design, Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design
- K171866 — Sentrant Introducer Sheath with Hydrophilic Coating
- K172565 — Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device
- K172886 — Breakaway Screw System
- K172989 — Electric Breast Pump
- K173115 — COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS
- K173125 — T2 STRATOSPHERE Expandable Corpectomy System
- K173182 — ProLift® Expandable System
- K173349 — Operio
- K173555 — LOGIQ E10
- K173578 — Biograph mCT Family of PET/CT Systems
- K173662 — speX Support Catheter
- K173685 — Peel-Away Introducer Set
- DEN160062 — IlluminOss Bone Stabilization System
- DEN170075 — ContainOR
- K170862 — Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope
- K171012 — Veraview X800
- K171552 — Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
- K171834 — G Surgical OCT Spinal System
- K171889 — Reusable Blood Pressure Cuff
- K172677 — Advantage Plus Pass-Thru
- K172743 — Natus VikingQuest
- K172861 — Digital thermometer(with disposable thermometer cover)
- K172944 — VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 >=16 µg/mL
- K172982 — SuperGrow 272, Ultimate 272
- K172986 — Zmachine Synergy
- K173130 — Reform® Midline Cortical Screw System
- K173251 — LumiCoil Platinum Fiducial Marker
- K173307 — Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL
- K173600 — MAGNETOM Amira
- K173618 — ACUSON AcuNav Volume Intracardiac Echocardiography Catheter
- K173646 — FS Ergo
- K173696 — TBL-ABI System
- K171174 — PERIO-FLOW nozzle
- K171193 — Certa Catheter
- K171858 — Sidus Stem-Free Shoulder
- K172286 — Automated Blood Coagulation Analyzer CS-2500
- K172918 — DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)
- K173124 — PEEK Biosolution
- K171909 — HAL for Medical Use (Lower Limb Type)
- K163607 — ECG Acquisition Systems
- K170029 — FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile
- K170497 — V10
- K170913 — Composite Removable Sinus Stent System
- K171271 — Polyform Synthetic Mesh
- K171483 — ArchFlo CT Midline
- K171611 — Double Lumen Ovum Aspiration Needles
- K172228 — pioli IOL Delivery System
- K172311 — BioFlux Device
- K172337 — MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL)
- K172350 — AxSOS 3 Ti
- K172465 — Idys TLIF 3DTi Cages
- K172473 — LifeStyles® SKYN® Intimate Moments Personal Lubricant
- K172482 — The Nellcor pulse oximetry monitor interface cable
- K172494 — PROTEUS PTA Balloon Catheter with Embolic Capture Feature
- K172573 — ReBOSSIS85
- K172594 — Proficient® Posterior Cervical Spine System
- K172844 — Cellvizio 100 Series System with Confocal Miniprobes
- K172888 — EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, EIT Cellular Titanium® ALIF Cages
- K173017 — Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
- K173354 — BD Nexiva Diffusics Closed IV Catheter Systems
- K173532 — Raider Guidewire
- K173687 — Strange Bile Duct Stone Exploration Set
- K170389 — TAURUS PEEK Cage System
- K170414 — Arthrex Univers Revers Apex Humeral Stems
- K170881 — ISP Safety Huber Needle Infusion Set
- K171748 — Vitrification Kit and Thawing Kit
- K172009 — Cascadia Interbody System
- K172238 — CAREline Airless Hemodialysis Blood Tubing Sets
- K172349 — InFill® Interbody Fusion Device
- K172676 — NuVasive® Modulus-C Interbody System
- K172732 — E-CUBE 8
- K172854 — NobelPerfect Abutments
- K172863 — Infinix-i, INFX-8000V, V7.0
- K173013 — WishBone K-Wire System
- K173043 — Holycon Synthetic Absorbable Sutures
- K173286 — Cannulated Screw Internal Fixation System
- K173434 — 2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300
- K173550 — Akros FibuLink Syndesmosis Repair Kit
- K170790 — SAM CRRT Unit, SAM Cassette CRRT
- K170846 — Disposable Insulin Pen Needle
- K171058 — Medacta Shoulder System: Threaded Glenoid Baseplate
- K171167 — Prodigio Stain Powder
- K171381 — Adhesive Electrodes
- K171480 — NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System
- K171729 — Fixtemp C&B
- K171781 — eVox System
- K172052 — Arthrex DynaNite Nitinol Staple
- K172056 — InnoSight Diagnostic Ultrasound System
- K172217 — Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath
- K172651 — FMP Extended Liners
- K172692 — Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens
- K172932 — True Flow Valvuloplasty Perfusion Catheter
- K173002 — 2940 nm Er:Yag Laser Handpiece
- K173369 — DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System
- K173374 — TSV BellaTek Encode Healing Abutments
- K173441 — Neurosoft TMS (also CloudTMS)
- K173502 — Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
Data sourced from openFDA. This site is unofficial and independent of the FDA.