FDA 510(k) clearances — page 229
clearances on record, most recent first.
Clearances — page 229
22,801–22,900 of 176,542- K190716 — Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead
- K191257 — Erchonia EVRL
- K191352 — binx health io CT/NG Assay
- K191575 — ARx Spinal System
- K183276 — 7D Surgical System
- K190650 — Revolution Centrifugal Blood Pump
- K190885 — Elevation Spine Saber-C System
- K190893 — Non-invasive Hemodynamic Blood Pressure Monitor
- K191012 — Navigated Pedicle Access Kit
- K191274 — BonAlive Granules
- K191394 — ILLUMISITE Platform
- K191606 — RenovoCath
- K191840 — Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)
- K191841 — Accurate Multi Panel Drug Urine Test Cup
- K191871 — 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set
- K183120 — EmboCube Embolization Gelatin
- K183387 — M3290B Patient Information Center iX
- K183458 — exoplan 2.3
- K190502 — ENFit Oral / Enteral Syringe
- K190535 — BiMobile Dual Mobility System - E-Dur Inserts
- K190992 — OrthoPediatrics PediFoot Deformity Corrections System
- K191158 — The AIO Solution
- K191295 — Percutaneous Introducer Needle
- K191423 — Normandy VBR System
- K191565 — Endoskeleton TCS Interbody Fusion Device
- K191781 — Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System
- K191835 — CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments
- K183305 — Crossing Support Catheter
- K183323 — UPJ Occlusion Balloon Catheter
- K190399 — Beddr 200 System
- K191033 — LunaGuard Nighttime Dental Protector
- K191222 — Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV
- K191225 — EEG Electrode Template
- K191262 — aBSI
- K191496 — TDS Standard Solution
- K191766 — VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)
- K191877 — FLUOROspeed
- K181154 — Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor
- K181216 — HAMILTON-T1, HAMILTON-C1
- K183088 — ADVIA Centaur Erythropoietin (EPO) assay
- K183091 — Elaris Pedicle Screw System
- K183112 — DiLumen Endolumenal Interventional Knife (DiLumen IK)
- K190090 — DynoSense Vital Sign Measuring System
- K190293 — Single Use Cytology Brush BC-205D
- K190338 — 046 Zenith Flex
- K191143 — PowerFlow Implantable Apheresis IV Port
- K191217 — JAZZ PF
- K191321 — Primelase Excellence
- K191505 — Rezum System
- K191546 — Epicardial Access System
- K191602 — APA Oxy Blade
- K191741 — Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape
- K191813 — MobileDiagnost wDR 2.2
- K182818 — LOQTEQ VA Calcaneus Plate 3.5
- K182871 — Mini TENS Therapy Device
- K183193 — MREplus+ Software
- K183590 — Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip
- K190176 — MINAMO
- K190887 — Leksell Vantage Stereotactic System
- K191190 — Steerable Introducer
- K191192 — SurgTech GENOLL Total Knee System
- K191214 — JO Premium Jelly Original Personal Lubricant
- K191267 — ImagingRing System on Rails
- K191469 — Biotronik Stylets
- K191499 — MAGLUMI 2000 25-OH Vitamin D
- K191559 — AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM
- K190672 — StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1
- K190732 — P200TxE
- K190777 — DemeTECH DemeFORCE Nonabsorbable Surgical Suture
- K190891 — Fluobeam LX
- K191183 — EyeBOX
- K191510 — Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae
- K191611 — Diode Laser Therapy Systems
- K191761 — Mobius3D
- K191764 — Inion BioRestore
- K191773 — GORE BIO-A Tissue Reinforcement
- K191795 — AOCup Lens Case with AODisc
- K191931 — HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)
- K180295 — Hamilton-G5
- K181743 — Blood Transfer Accessory (BTA)
- K181754 — Blood Collection Accessory (BUCA)
- K182089 — Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs
- K183288 — Transcutaneous Electrical Nerve Stimulator
- K183547 — Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter
- K190132 — Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter
- K190274 — Endotracheal Tube
- K190291 — Addivation Medical Cervical Interbody System
- K191454 — Atellica CH Amylase_2 (AMY_2)
- K191484 — Renuvion/J-Plasma Precise Handpiece
- K191768 — AXS Vecta Aspiration System
- K183048 — Quantisal II Oral Fluid Collection Device
- K190339 — Helioseal F Plus
- K190569 — Shaders ZR
- K190809 — Sample Imaging for Senographe Pristina
- K190886 — Non-invasive blood pressure measurement systems
- K190907 — ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System
- K191136 — Access CT
- K191154 — Hair Boom 69
- K191240 — ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System
- K191289 — Bone Screw Line Addition
Data sourced from openFDA. This site is unofficial and independent of the FDA.