FDA 510(k) clearances — page 193
clearances on record, most recent first.
Clearances — page 193
19,201–19,300 of 176,479- K201768 — Voluson E10
- K202180 — Broncoflex Agile +3 more
- K202428 — AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories
- K202817 — GEO Bone Screw System
- K202948 — EzOrtho
- K192771 — C4 Fiducial Marker
- K193552 — InnovaMatrix
- K200507 — PRO-DENSE LoVisc Bone Graft Substitute
- K201155 — PleurX Peritoneal Catheter System
- K201268 — Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
- K201415 — Vial2Bag Advanced 20mm Admixture Device
- K201427 — Trivergent Spinal Fixation System
- K201438 — ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer
- K201610 — IonicRF Generator
- K201670 — YSIO X.pree
- K201688 — S.I.N. Instrument Kits
- K201724 — Pentacam AXL Wave
- K201884 — ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm
- K202030 — OASIS MRI System
- K202044 — Powerpress Recovery Unit
- K202472 — ACTIS Duofix Hip Prosthesis
- K202760 — Iridex 810 Laser
- K202799 — EVA15
- K181477 — MS Lide Implant Systems
- K193000 — Hexanium® ACIF
- K200794 — AccelFix Spinal Fixation System
- K201139 — WEGO-PDO Barbed Suture
- K202393 — SpineJack Expansion Kit
- K202756 — Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A)
- K200084 — Zavation IBF System
- K200237 — Transcutaneous Electronic Nerve Stimulator
- K200821 — anti-bacterial bandage
- K201572 — TAPESTRY Biointegrative Implant
- K201771 — Single Use Rotatable and Repositionable Hemoclip
- K202100 — Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS)
- K202374 — 4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+
- K202771 — CD Horizon Spinal System
- K193474 — Selectra 3D Outer Guiding Catheters
- K200045 — MUTARS Cemented Femoral Stems
- K200408 — VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium
- K200595 — CellaVision DC-1, CellaVision DC-1 PPA
- K200906 — MINICONE Implant
- K201129 — Medline Smoke Evacuation Pencil
- K201396 — Finetest Lite Smart Blood Glucose Monitoring System
- K201535 — Cerament Bone Void Filler
- K201710 — A View LCS
- K201803 — OSSIOfiber Hammertoe Fixation System/OSSIOfiber Hammertoe Fixation Implant
- K201816 — ARTHROTAP
- K202010 — Disposable Vinyl Glove
- K202016 — Dall-Miles® Cable System
- K202193 — PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament Reconstruction
- K202733 — Quantum Ventilation Module
- K202737 — Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Xario200G and Xario100G, Diagnostic Ultrasound System
- K200207 — xPORT S Lens Fragmentation System
- K200296 — Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses
- K200718 — Arthrosurface WristMotion Total Wrist Arthroplasty System
- K200757 — Foley Catheter with Temperature Sensor
- K200764 — STATSTIX
- K201398 — SINUSPRIME Dilation System
- K201587 — icotec Anterior Cervical Plate System
- K201615 — SIGNA 7.0T
- K201908 — LIAISON Testosterone xt
- K202041 — Opera Evo
- K202327 — Invictus OsseoScrew® System
- K202340 — Droplet Pen Needle 30G & 33G
- K202349 — Cartesion Prime, PCD-1000A, V10.7
- K202364 — Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1
- K202665 — Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm
- K202680 — OsteoMed ExtremiFix Mini & Small Cannulated Screw System
- K202683 — ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound System
- K200386 — Z5-BL
- K201562 — Spirotrac
- K201595 — Merit Hydrophilic Guide Wire
- K202666 — CONSTRUX Mini PTC Spacer System
- K200114 — Astroglide Organix Liquid
- K200596 — G21 Cement, VADER® Pedicle System
- K201962 — Skeletal Dynamics Ulnar Shortening Plating System
- K202305 — Zavation IBF System
- K200633 — Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove
- K201528 — Yushan X-Ray Flat Panel Detector with DROC
- K201828 — Voluson SWIFT, Voluson SWIFT+
- K202213 — syngo.CT Neuro Perfusion
- K202501 — Quantib Prostate
- K192921 — Zeos Aqua Vision Pump and tube
- K193631 — Stethee Pro 1, Stethee Pro Software System
- K200103 — BIOTEQ Drainage Catheter Set (One Step Type)
- K200434 — V20, V20a, AVSM3 SNF
- K200510 — Multi-LinkTM X2 ECG Adapter and Leadwires
- K201038 — Luce Ceramic Bracket
- K201377 — SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter
- K201882 — AEON Endoscopic Stapler
- K201983 — BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)
- K202285 — Medline ENfit OTC Feeding Syringe
- K202609 — Instrument Clamps Electromagnetic
- K202740 — Klassic Knee System Tibial Inserts, PS-Max
- K192703 — Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update
- K193542 — Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22
- K200661 — Steripath Micro Blood Collection System
- K200767 — SilverStream Gel
- K200793 — LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System
Data sourced from openFDA. This site is unofficial and independent of the FDA.