FDA 510(k) clearances — page 250
clearances on record, most recent first.
Clearances — page 250
24,901–25,000 of 175,699- K171547 — Qualisys Clinical System
- K171977 — miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer
- K173280 — Neonatal ConchaSmart Breathing Circuits
- K173531 — Lockbox for Perfusor Space PCA Infusion Pump
- K173869 — Med-link Reusable Blood Pressure Cuff
- K173923 — Temporary Cardiac Pacing Wire
- K180150 — PL8 Wrist Reconstruction Plate
- K181007 — Cianna Medical SAVI Scout Reflector and SAVI Scout System
- K181094 — Polydioxanone Surgical Scaffold
- K181182 — DYNACORD Suture
- K181257 — PlasmaBlade X 3.0S, PlasmaBlade X 4.0
- K181432 — ProVectra 3D Prime with VistaSoft
- K181562 — Curiteva Anterior Cervical Plate System
- K181804 — Alphenix, INFX-8000C/B, V8.0
- K181830 — Azurion R2.0
- K180647 — BriefCase
- K180703 — VITA YZ ST and VITA YZ XT
- K180737 — Ultrasound Scanner System bk2300
- K180764 — TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)
- K180770 — Propeller Sensor for Neohaler
- K181480 — MMD Tip
- K181666 — Smart One
- K181749 — SuperCable® Iso-Elastic Cerclage System
- K181772 — NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)
- DEN180008 — MolecuLight i:X
- K180874 — 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield
- K181272 — Picocare Family
- K181422 — SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit
- K181708 — MTS Plazomicin 0.016-256 µg/mL
- K172273 — 308nm Excimer System
- K180912 — TE7/TE5 Diagnostic Ultrasound System
- K181213 — ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control
- K181431 — Laser Ureteral Catheter
- K181440 — Proficient® Posterior Cervical Spine System
- K181720 — Epiphany Cardio Server Mobile
- K181736 — CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,
- K181741 — IceSphere 1.5 CX Cryoablation Needle
- K172616 — Pulse Oximeter
- K173474 — RetiCapture
- K173808 — Voutia
- K180064 — OsteoFab Patient Specific Cranial Device
- K180076 — Ti 3Z Interbody System
- K180485 — Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender
- K180556 — Corelink Foundation 3D Anterior Lumbar System
- K180580 — Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices
- K180627 — Macroduct Advanced Model 3710
- K181156 — Panther Fusion GBS Assay
- K181184 — OIC Intramedullary Nail System
- K181395 — Universal Cannula Seal (5-12 mm)
- K181452 — RCT800
- K181485 — EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System
- K181554 — Stowe Pedicle Screw System
- K181694 — FlowTriever Retrieval/Aspiration System
- K181763 — FUJIFILM Ultrasonic Endoscope
- K173107 — Vios Central Station Monitor Software, Vios Central Server Software
- K173656 — Arthrex FibuLock Nail
- K180272 — Saniclave 250
- K180958 — Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable
- K181268 — PROLENE (Polypropylene) 3D Patch
- K181401 — RxSight Insertion Device
- K181579 — eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K
- K181659 — Avologi ENEO
- K181699 — Level 1 Convective Warmer
- K181706 — neuromate Gen III
- K181712 — San Antonio Stopcock
- K181790 — CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
- K181855 — RadialSeal Introducer Kit
- K173837 — RHYTHMIA HDx Mapping System (with software Version 2.0)
- K173947 — Lumbar Interbody Fusion System (OLLIF)
- K180226 — TREND II Spinal Fixation System- STEP Series
- K180407 — Smartinhaler
- K180632 — Exactech Equinoxe Small Reverse Shoulder System
- K180752 — Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole
- K180960 — FIXIT / ComposiTCP Threaded Anchor System
- K181453 — ATEC ALIF Spacer System
- K181495 — Republic Spine Dark Star Spinal System
- K181670 — Alphenix, INFX-8000V/B, V8.0
- K172095 — Autokeeper
- K172862 — Portable ECG Monitor (ECG3)
- K173929 — CipherOx CRI M1
- K173943 — Dental High-speed Handpiece and Accessories
- K180017 — MX40 Release C.01
- K180115 — TWBM Pump
- K180218 — Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
- K180544 — DePuy Synthes Static Staples
- K181025 — I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System
- K181095 — RF-Relief
- K181178 — S-mini active Fixture
- K181339 — Altus Spine Pedicle Screw System
- K181399 — FIREFLY® Pedicle Screw Navigation Guide
- K181686 — CELERITY 20 Steam Biological Indicator
- K171888 — Non-contact infrared body thermometer
- K173444 — Quantitative Total Extensible Imaging (QTxI)
- K173645 — JASPER Spinal Fixation System
- K180518 — GME LinScan Lite 808 Laser System
- K180854 — Voyager Trajectory Array Guide (V-TAG)
- K181083 — Stryker All-PEEK Knotless Anchor System
- K181242 — Braun BNT400 No Touch + Forehead Thermometer
- K181398 — DV-300 Aspirator
- DEN170009 — Bonebridge
Data sourced from openFDA. This site is unofficial and independent of the FDA.