FDA 510(k) clearances — page 263
clearances on record, most recent first.
Clearances — page 263
26,201–26,300 of 175,699- 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
- K172868 — Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls
- K173145 — CereMetrix Silver
- K173186 — S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D
- K173367 — MC 300* Nebulizer
- K173633 — VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag
- K173678 — Diode Laser Cap
- K173691 — Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack
- K173707 — P200TE
- K173729 — REVIAN RED
- K173736 — TrackX
- K173739 — ALOKA ARIETTA 850
- K173763 — iovera system
- K173817 — Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 µg/mL
- K180242 — HeRO Symphony, HeRO ES, HeRO solo/duet
- K180244 — EnsoETM
- K180255 — CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
- K170623 — ACE Hemoglobin A1c (HbA1c) Reagent
- K171476 — SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)
- K172042 — NeuroNav System, NeuroSmart System
- K172044 — Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action S
- K173275 — OMNICHROMA
- K173324 — ALTA Anterior Cervical Interbody Spacer
- K173343 — Zygomatic Implant System
- K173683 — LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers
- K173746 — Activmotion Range
- K180237 — Rezum System
- K170175 — ENDOSEAL MTA
- K171637 — OpClear System
- K171668 — Bluetooth blood pressure monitor
- K171797 — TRYPTIK2 C-Plate Anterior Cervical Plate System
- K172320 — Neurostructures Cavetto® Cervical Cage System
- K172899 — Vygon PICCs
- K180327 — Stryker iVAS 13g Bone Biopsy Kit
- K173643 — Trilor Disks, Blocks and Arches
- K170540 — DM-Density
- K171601 — Ultraxx Nephrostomy Balloon Catheter
- K171671 — Prismaflex System 8.10
- K171869 — Sutter CURIS RF Generator
- K172324 — Axiostat Chitosan Hemostatic Dressing
- K173077 — Cavetto-SA Cervical Cage System
- K173224 — SPIN-SWI
- K173303 — INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)
- K173320 — KLS Martin L1 MMF System
Data sourced from openFDA. This site is unofficial and independent of the FDA.