FDA 510(k) clearances — page 240
clearances on record, most recent first.
Clearances — page 240
23,901–24,000 of 176,542- K190104 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System
- K190252 — MTS Gentamicin 0.016 - 256 µg/mL
- K190430 — OsteoCentric Bone Plate and Screw System
- K173191 — A&D Medical Blood Pressure Monitors
- K181822 — RENASYS Touch; RENASYS Y-Connector
- K182064 — ExpanSure Transseptal Dilation System
- K182074 — Mineral Collagen Composite Bioactive Moldable
- K182918 — Ballast 088 Long Sheath
- K183582 — MPACT Extension
- K183592 — ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer
- K190377 — UroLift System UL400
- K190380 — nvc
- K190412 — CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
- K190418 — NuVasive® VersaTie® System
- K190425 — CastleLoc-P Anterior Cervical Plate System
- K190431 — Route 92 Medical Delivery Catheter
- K182511 — SimplCath
- K183399 — BD Nexiva Closed IV Catheter System
- K183408 — Jensen Shade Effect Liquids
- K183414 — ABSOLU
- K183543 — ACTIV.A.C. Therapy Unit
- K183575 — ACUSON S3000, S2000 Diagnostic Ultrasound System
- K180098 — SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1
- K182383 — Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue
- K182468 — Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System
- K182793 — AP3600 Automated Instrument
- K183019 — SIS Software version 3.3.0
- K183527 — MTS Ciprofloxacin 0.002 - 32 µg/mL
- K183529 — AE-120A EEG Head Set
- K190379 — MIM on Linux
- K190423 — Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System
- K181599 — Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application
- K183260 — Sensilight Pro / Pistol IPL
- K183296 — REAL Immersive System
- K183344 — The Progressive Orthopaedic Company Total Knee System II
- K183511 — Affinity Pixie Oxygenator with Balance Biosurface (Model BBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (Model BBP241), Affinity Pixie Oxygenator with Cortiva BioActive Surface (Model CBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Cortiva BioActive Surface (Model CBP241)
- K183518 — Preat Abutments
- K190204 — ID NOW Influenza A & B 2
- K190333 — Paradigm All-Suture Anchor 1.8mm, White/Black #2
- K190354 — BRAUN Silk.expert Pro 5
- K190361 — Zavation Spinal System
- K190366 — BRAUN Silk Expert Pro 3
- K190359 — Sonendo GentleWave System
- K180127 — TCAT (R) THA Instrument Tray Set
- K181633 — MTF Pre-Sutured Tendon
- K182022 — ApexMV
- K182571 — CardioFlux with Faraday Analytical Cloud
- K182639 — MOBILETT Elara Max
- K182813 — COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT
- K182853 — HORIZON TMS Therapy System
- K183187 — nextaro Transfer System, nextaro va
- K183426 — MectaLIF Anterior Stand Alone Extension
- K183493 — SelectSite C304-HIS Deflectable Catheter System
- K183501 — Parcus Twist AP Suture Anchors
- K183657 — Vantage Galan 3T, MRT-3020/A9, V5.0
- K190099 — Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch
- K190280 — Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly
- K190294 — CELL-DYN Emerald 22 AL System
- K190347 — HIVOX OTC Electrical Stimulator
- K190357 — Star-X, Intraoral X-ray System
- K190373 — SonialVision G4
- K190401 — MAMBA and MAMBA Flex Microcatheters
- K190476 — FUJIFILM Sonosite Vevo MD Imaging System
- DEN170044 — ClearMate
- K180337 — EUROPA Pedicle Screw System
- K181669 — ConvertX Biliary Stent System
- K182203 — JKH Stimulator Plus
- K182371 — da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories
- K182475 — Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters)
- K182579 — Omron Model BP7900 Blood Pressure Monitor + EKG
- K182589 — BD Plastipak Syringe
- K183142 — PathVisionXL
- K183247 — dpl Faceware
- K183380 — Tetric PowerFill
- K183573 — Vstrip H. pylori Antigen Rapid Test
- K190168 — Aquas Probes
- K190283 — PROSTIM Injectable Inductive Graft
- K190285 — L300 Go System
- K190318 — VASOBand Vascular Compression Device
- K190326 — VITROS XT Chemistry Products UREA-CREA Slides
- K181668 — FasTouch Absorbable Fixation System
- K182502 — Alteon Acetabular Cup System
- K182570 — Venture 0.014 Catheter
- K182920 — MiRus Lumbar Interbody Fusion System consisting of CALLISTO PEEK Posterior Lumbar Interbody Fusion (PLIF) +3 more
- K183026 — Wright Jones Fracture System
- K183113 — DePuy Synthes Maxillofacial Portfolio - MR Conditional
- K183238 — BeneVision Central Monitoring System
- K183430 — Modular Spinal Fixation System
- K183463 — AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm
- K183464 — AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)
- K183472 — DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio MR Conditional
- K183492 — JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD Monitor
- K183600 — Anchor Bag-Alone Tissue Retrieval System by ConMed
- K190296 — GammaTile
- K190300 — BIOK7600W Wireless Flat Panel Detector
- K190311 — BIOK7600 Flat Panel Detector
- K190368 — Enhanced Feature Software Pack CXDI Series
- DEN180017 — Quantra Hemostasis Analyzer, QPlus Cartridge
- K181447 — Safety insulin needle for single use
- K181610 — ActivOrtho Nitinol Compression Screw System
Data sourced from openFDA. This site is unofficial and independent of the FDA.