FDA 510(k) clearances — page 255
clearances on record, most recent first.
Clearances — page 255
25,401–25,500 of 175,699- K173045 — Oximeter
- K173093 — TAMA BEMS device
- K173821 — LungQ Software
- K173961 — Straumann BLX Implant System
- K180191 — SuperBall Meniscal Repair System
- K180593 — Vbeam Prima Laser System
- K180608 — Lunoa System
- K180661 — SIGMA Sterilization Pouch and Roll
- K171609 — Check-Flo Performer Introducer Micropuncture Radial Artery Access Set
- K172763 — Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder
- K172807 — Silicone Foley Catheter for single use
- K180447 — reVive Light Therapy LED Cleansing System
- K180500 — VariAx 2 System
- K180640 — SmartClip Soft Tissue Marker
- K181012 — BUHLMANN fCAL ELISA
- K171798 — Silverwear Silver Pro Garment Device
- K172068 — Kenz Cardico1211
- K172234 — Oxygen Concentrator
- K172410 — Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters
- K172499 — NEOSHIELD
- K172765 — Smart Moves Complete
- K173330 — PanNAT STEC Test
- K173975 — UF(II) Wide Fixture
- K180026 — Bowel Management Device, Bowel Management Irrigation Set
- K180045 — Omnipod DASH Insulin Management System
- K180136 — BioNude Lubricant
- K180189 — InMode System with Fractora3D/3D-90 Applicators
- K180238 — CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT
- K180325 — Single Use MultiClip Device
- K180617 — Hair Up
- K180800 — Colonic Plus Regular, Small, and Straight Shape Hydrokit
- K180855 — Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System
- K170703 — Single Use Arthroscopic Electrode (with Pencil)
- K171828 — ETCO2 Sensor
- K172690 — ToFscan
- K173415 — EndoWrist 5mm Thoracic Grasper
- K173906 — da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories
- K180464 — AEVUMED PHANTOM Suture Anchors
- K180480 — ATEC Universal Spacer System
- K180582 — Sternal Cable System
- K180606 — SOMAVAC Device
- K181098 — ACUSON SC2000 Diagnostic Ultrasound System
- K181122 — CARDIOSAVE Intra-Aortic Balloon Pump
- K181177 — Interventional Workspot
- K171019 — ScioCardio ECG Transmitter
- K172825 — MN-111
- K173246 — ANEROID SPHYGMOMANOMETER
- K173269 — KATOR Suture Anchor
- K173483 — Pure Flow External Counter-Pulsation Device
- K173951 — Legend Acetabular Liners
- K180167 — Playtex Stella Tampons
- K180293 — Retia 2
- K180361 — MICRORAPTOR REGENESORB Suture Anchor
- K181188 — EVEREST Spinal System
- K172871 — SpineKure Kyphoplasty System
- K173157 — Dr's Light2
- K180174 — Belun Ring
- K180553 — VERIFY Spore Test Strip for S40 Sterilant
- K180572 — AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10
- K181132 — Tri-Ad 2.0 Adams Tricuspid Band
- K172147 — STAR 65
- K172242 — DripAssist Plus
- K172717 — Automatic Tissue Processing Unit
- K172889 — Infrared Thermometer
- K173005 — SURECELL Gelling Fiber Wound Dressing
- K173834 — Quantum Pump Console
- K173914 — VORTRAN Cuff Inflator (VCI)
- K180111 — ClearGuard HD Antimicrobial Barrier Cap
- K180163 — TransEnterix Senhance Surgical System
- K180356 — inui In-Home Urine Analysis Test System
- K180402 — PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar
- K180711 — FUJIFILM Endoscopic CO2 Regulator GW-100
- K181082 — ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)
- K181150 — ProtekDuo Mini Veno-Venous Cannula Set
- DEN180005 — OsteoDetect
- K170697 — GBR system
- K172582 — EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern
- K172665 — Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords
- K172708 — T2Bacteria Panel
- K173938 — IS-III HActive Fixture
- K180414 — EPX-4440FN Digital Video Processor with Light Source
- K180543 — GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85
- K180756 — Safety Wire Guide Introducer
- K180807 — Celling Aspiration Needle
- K180862 — Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System
- K180976 — PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels
- K181077 — ActiGraph CentrePoint Insight Watch
- K181080 — McKesson Cardiology
- K181108 — Fresenius Liberty Select Cycler
- K181136 — CS 9600
- K173722 — PATRIOT COLONIAL Spacer, SUSTAIN Spacer
- K180201 — Route 92 Medical Access System
- K180403 — ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 45 cm Shaft Length
- K180609 — Rodo Smilekey
- K180811 — Biograph Vision
- K181024 — DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips
- K181059 — geko T-3 Neuromuscular Stimulator
- K181067 — AlignX Ankle Fusion System
- K173405 — DiLumen Endolumenal Interventional Scissors (DiLumen Is)
- K173862 — Pantheris System
Data sourced from openFDA. This site is unofficial and independent of the FDA.