FDA 510(k) clearances — page 273
clearances on record, most recent first.
Clearances — page 273
27,201–27,300 of 176,542- K180123 — Breast BI 7 MR Coil 1.5T Mammavention
- K180128 — Warrior 14 guidewire
- K180141 — SPIWay Endonasal Access Guide
- K171535 — SURGICAL ISOLATION GOWN
- K171604 — Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip
- K172613 — Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit
- K173212 — Instant-view-PLUS immunochemical Fecal Occult Blood Test
- K173288 — CorPath GRX System
- K173352 — Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)
- K173580 — Vinyl Patient Examination Glove (Yellow)
- K173636 — Velocity
- K173644 — Gazelle Polypropylene Suture and Delivery Device
- K173750 — Prelude IDeal Hydrophilic Sheath Introducer
- K173877 — BOWA Neutral Electrodes
- K180137 — AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF)
- K180138 — AtriCure cryoICE cryo-ablation probe (CRYO2)
- DEN170045 — Banyan BTI
- K172439 — Siberian Fit
- K173185 — SEURAT Universal Pedicle Screw System
- K173545 — TEMED Gas Diffuser
- K173565 — Sunrise 6200, Sunrise 7200
- K173567 — Sera
- K173651 — Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set
- K180158 — Surgical Laser fibers
- DEN170073 — ContaCT
- K171825 — Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument
- K172058 — CT6485, CT12885
- K172624 — Voyant 5mm Fusion Device
- K172839 — ENDOSOLV
- K172870 — Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J
- K173195 — DRI Hydrocodone Assay
- K173313 — SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP
- K173315 — SupaChair Powered Wheelchair
- K173535 — Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device
- K173592 — MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit
- K180288 — QuickVue Influenza A+B
- K170793 — SuRgical Planner (SRP)
- K171495 — Zyston Strut Open Titanium Spacer System
- K171933 — ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter
- K172775 — MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle
- K172883 — Home Use Hair Removal Device/T1, T2, T3
- K172941 — CASCADIA Interbody System
- K173527 — Digitex Delivery Device
- K173561 — Vinyl Patient Examination Glove (Yellow)
- K173579 — Thorecon Fixation System
- K173634 — CELERITY 20 Steam Biological Indicator
- K173670 — CELERITY 20 Steam Incubator
- K173710 — MotoBAND CP Implant System
- K180118 — Arthrex NanoSuture Anchor
- K180082 — geko T-2 and geko Plus R-2
- K170131 — TAV Medical Dental Implants System
- K171179 — BR Type Implant System
- K171455 — AT-6XX Series Infrared Thermometer
- K171631 — Standard Catheter Set
- K171755 — CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System
- K172160 — Southern Implants PEEK Abutments
- K172180 — OSCAR 15
- K172284 — NAPA LP-15 Airway Pressure Monitor
- K172422 — Kohli Urinary Drainage Catheter
- K172504 — Tosama Biobased Applicator Tube Menstrual Tampon
- K172746 — VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label
- K172748 — VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack
- K172749 — Vis-U-All Low Temperature Sterilization Pouch/Tubing
- K172751 — iVitri Straw
- K172752 — CELERITY 20 HP Biological Indicator
- K172753 — VERIFY VH2O2 Indicator Tape
- K172754 — V-PRO maX 2 Low Temperature Sterilization System
- K172755 — PRO-LITE Sterilization Trays
- K173163 — ChlorCid, ChlorCid V, ChlorCid Surf
- K173272 — Ergonomic Handle
- K173400 — ORISE Tissue Retractor System
- K173435 — 3M Attest Rapid Readout Biological Indicator
- K173501 — Meridian Vaginal Positioning System (VPS)
- K173523 — BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL)
- K173791 — Leksell GammaPlan
- K173823 — Amrad Medical AAU Digital Radiography System +3 more
- K173894 — Jade PTA Balloon Dilatation Catheter
- K180107 — Blue Sky Bio Aligner
- K162727 — SENYINT Remote Consultation System
- K173025 — NuVasive® MLX® Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP Expandable XLIF System
- K173244 — superDimension Navigation System V7.2
- K173335 — Gazelle PTFE and Suture Delivery Device
- K173411 — Comprehensive Segmental Revision System (SRS)
- K173537 — CONCORDE LIFT
- K173553 — LUCAS 3 Chest Compression System
- K173805 — NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm)
- K180084 — Ultrasound System SONIMAGE MX1
- K180091 — UNiD Spine Analyzer
- K161222 — PENTAX MEDICAL ED-3490TK, Video Duodenoscope
- K171520 — SteriZign Signatur Device Protection System
- K171861 — CAPILLARYS Hb A1c
- K172698 — G-Beam Fusion Beaming System
- K173199 — PicoSure Workstation
- K173450 — PRESS DUO elite, PRESS DUO elite AG
- K173826 — THP Hip Fracture Plating System
- K180067 — ACUSON X800 Diagnostic Ultrasound System
- K171375 — Gammex PI Breach Detect Powder Free Surgical Glove
- K171557 — AcQRef Introducer Sheath
- K171641 — Accula Flu A/Flu B Test
- K172490 — eUnity
Data sourced from openFDA. This site is unofficial and independent of the FDA.