FDA 510(k) clearances — page 271
clearances on record, most recent first.
Clearances — page 271
27,001–27,100 of 176,542- K173481 — Amsco Evolution Medium Steam Sterilizer
- K173682 — L300 Go System
- K173690 — Grass TWin
- K173796 — Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references)
- K173812 — Catalyst CSR 3 Peg Glenoids
- K173904 — CATS Tonometer Prism
- K173939 — Quantib Brain
- K180057 — VORTEK URETERAL DOUBLE LOOP STENT
- K180061 — UltraCor Twirl Breast Tissue Marker
- K180159 — Klassic® Knee System
- K180394 — BrightMatter Plan 1.6.0
- K171150 — AW-100
- K171320 — ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION Screws
- K172115 — Navigated Instrument System
- K172892 — Neuro Assessment System NAS-1000
- K173075 — ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)
- K173249 — CD HORIZON Spinal System
- K173323 — AnastoClip GC Closure System
- K173440 — Carriere SLX 3D Clear
- K173500 — NMF004A
- K173605 — iQMR
- K173625 — syngo.CT Clinical Extensions
- K173713 — HS70A Diagnostic Ultrasound System
- K173769 — DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid
- K173772 — BreathID Hp System
- K173777 — BreathID Hp Lab System
- K180044 — SIROLaser Blue
- K180086 — Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter
- K180092 — Intellitorq
- K180105 — Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister
- K180135 — THD Anopress with THD SensyProbe
- K180171 — PillCam Patency System
- K180326 — icobrain
- K180335 — Accutension Smartphone Auscultatory Blood
- K171802 — ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
- K171810 — Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter
- K171939 — ALVUE Balloon Dilation System
- K172758 — Rotatable Snares, Non-Rotatable Snares
- K172810 — PORT-X IV
- K172818 — LMT-3000
- K173114 — primeMidline Catheters
- K180156 — SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System
- K180196 — On Call Express Mobile Blood Glucose Monitoring System
- K180321 — Aesculap Optilene Nonabsorbable Suture
- K180350 — Dornier Medilas H Solvo 35 Laser
- DEN170046 — 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
- K171750 — Citric Complete Dry Citric Acid (45X)
- K172267 — IRENE Thoracolumbar Fixation System
- K172381 — Digitimer DS7AP Constant Current Stimulator
- K173262 — Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter
- K173356 — Ingenia Elition S and Ingenia Elition X R5.4
- K173494 — OrthoSteady G Bone Cement
- K171715 — HammerTube System
- K172062 — AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray
- K172663 — Cytology Brush
- K172872 — DePuy Synthes Femoral Neck System
- K173453 — Valeo® C+CSC with Lumen Interbody Fusion Device
- K173723 — EMPOWR Universal Tibial Baseplate
- K173741 — Reprocessed ArthoCare Ablation Wand
- K173879 — MiniMed Mio Advance infusion set
- K173942 — Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
- K180334 — LEGION Knee System
- K162366 — Omega VL
- K170304 — Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers
- K171129 — CO Check Pro, CO Screen
- K171214 — Infrared Thermometer
- K171655 — cobas m 511 integrated hematology analyzer
- K172103 — Flowtron DVT5 Small Calf Garment
- K172135 — uCT Computed Tomography X-ray System
- K172256 — SoftVue
- K172331 — Type I, Type II, Type III, Type IV
- K172485 — Footmotion HammerToe
- K172590 — Spectra Optia Apheresis System
- K172601 — Next Generation iBOT
- K172972 — Wrist Type Automatic Blood Pressure Monitor
- K173223 — ologen Collagen Matrix
- K173256 — System 1 endo Liquid Chemical Sterilant Processing System
- K173281 — LigaSure Exact Dissector, Nano-coated
- K173312 — ProBx Software
- K173346 — LENSAR Laser System - fs 3D (LLS-fs 3D)
- K173428 — VERIFY Chemical Indicator for S40 Sterilant
- K173447 — V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit
- K173544 — Phoenix Wound Matrix
- K173624 — ORIGIO® Handling without phenol red (Cat. No. 8310), ORIGIO® Handling with phenol red (Cat. No. 8311)
- K173704 — ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip
- K173731 — SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031)
- K180265 — COMPACT TOUCH Ophthalmic Ultrasound System
- DEN160029 — SkinPen Precision System
- K171703 — PUMA System
- K171915 — Nathanson Transcystic Bile Duct Stone Exploration Pack
- K172500 — Technoweb Surgical Mask
- K172820 — Microscope Navigation Software
- K172916 — FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603
- K173488 — CELERITY 20 HP Challenge Pack
- K173680 — Sapphire II PRO
- K173788 — Arthrex Corkscrew FT
- K173806 — CorPath GRX System
- K180109 — STARband, STARlight, St. Louis Band
- K172750 — Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)
- K172797 — ECG Cable/Leadwires
Data sourced from openFDA. This site is unofficial and independent of the FDA.