FDA 510(k) clearances — page 233
clearances on record, most recent first.
Clearances — page 233
23,201–23,300 of 175,699- K182870 — Introcan Safety 3 Closed IV Catheter
- K183078 — VitalConnect Platform, VitalPatch Biosensor
- K183373 — Bonebridge
- K183551 — VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL)
- K190055 — Duo Lumbar Interbody Fusion Device
- K190098 — Endophys Pressure Sensing Sheath
- K190141 — HANAROSTENT LowAx Colon/Rectum (NNN)
- K190184 — iSLEEVE Introducer Set
- K181682 — VISULAS green
- K181807 — Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device)
- K181859 — Visualase Thermal Therapy System
- K182173 — Joule System
- K182966 — PLANET Onco Dose
- K183201 — Hearing Healthcare Pro
- K183289 — ClearGrasp Snare
- K183366 — GenePOC Strep A
- K183397 — ChoiceSpine Stealth Cervical Spacer System
- K180842 — MAC Medical D-Series Blanket and Solution Warming Cabinets
- K181656 — ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color)
- K182628 — Imagio Ultrasound Imaging System
- K183053 — Olympus Small Intestinal Capsule Endoscope System
- K183172 — Stryker SternalPlate System
- K190030 — Embrella Endoscopic Distal Attachment
- K181782 — Medline Reinforced Epidural Catheter
- K181843 — MLP Special Locking Bone Plate System
- K182225 — Dimension Vista High-Sensitivity Troponin I (TNIH) Assay
- K183384 — JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant
- K183453 — VS3-IR
- K190193 — SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices
- K190322 — SCARLET® AC-T Secured Anterior Cervical Cage
- K182495 — Electronic Blood Pressure Monitor
- DEN180021 — Early Bird Bleed Monitoring System
- K173793 — XactTrace Single Use Respiratory Effort Belt System
- K180050 — CurvaFix Intramedullary Rodscrew System
- K180852 — Manual Wheelchair
- K181475 — DxH 520 Hematology Instrument
- K181730 — BD Vacutainer Eclipse UltraFill Blood Collection Needle
- K181788 — Lead-free Chemical Indicators for Steam Sterilization
- K181871 — EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay
- K181932 — DTX Studio design
- K182710 — Fetal Doppler, Model FD88
- K182804 — Traditional Length GJ Feeding Device
- K182822 — Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System
- K183067 — Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System
- K183147 — BrackFix
- K183259 — Idys TLIF TiVac
- K183266 — EP-TRACER System
- K183401 — Vis-U-All Low Temperature Sterilization Pouch/Tubing
- K183402 — PRO-LITE Sterilization Tray
- K183478 — ClearON Mobile
- K183690 — Tenodesis Screw System
- K183702 — Polar Care Wave
- K183705 — IdentiTi Porous Ti Interbody System
- K190007 — Vydence Laser Family
- K190234 — ODI HD Dental Sensor
- K180479 — ReDS System
- K181528 — Austin Miller Large External Fixation System
- K182250 — Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm), , Solero microwave Tissue Ablation Applicator (19cm), Solero microwave Tissue Ablation Applicator (29cm)
- K182629 — Digital Thermometer
- K182839 — Lifetech Cardio Model 8301 Temporary Pacemaker
- K183099 — QUANTIEN Measurement System
- K183313 — EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)
- K183686 — FUJIFILM Endoscope Model EG-530N
- K180682 — AeroPro Cordless Prophy System
- K182003 — Lympha Press Optimal Plus
- K182267 — PAT (Pain Alleviation Technologies)
- K182494 — FlowMet-R
- K183014 — uPMR 790
- K183683 — FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5
- K190087 — EzDent-i / E2 / Prora View
- K190155 — FibermarX Radiopaque Tissue Marker
- K181870 — Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use
- K182052 — Omni Instrument Tray
- K182440 — Body System
- K182941 — HEALIX ADVANCE SP PEEK Anchor
- K183211 — 3M Comply Hydrogen Peroxide Chemical Indicator
- K183360 — VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 >=64/8 µg/mL)
- K183374 — GrayDuck Stent
- K183454 — Tyece OTC EMS System
- K190356 — ClariFix
- K182976 — SpringTMS
- K183179 — CAPERE Thrombectomy System
- K183290 — Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200
- K183698 — Zap-X Radiosurgery System
- K190071 — Perla® Posterior Cervico-Thoracic Fixation System
- K190151 — COBRA Fusion Ablation System
- K181310 — HeartCheck Cardi Beat ECG Monitor with GEMS Mobile
- K181551 — DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette
- K182406 — Altus Spine Interbody Fusion System
- K182488 — Reprocessed Response Diagnostic Electrophysiology Catheter
- K182542 — The EPAD 2 System
- K182643 — IRIS 1.0 System
- K182825 — FUJIFILM Ultrasonic Endoscope
- K182859 — Babyleo TN500
- K183240 — Empower RF Catheter
- K183365 — Libertas Acetabular Hooded Liner
- K183588 — Choice Spine Hawkeye Vertebral Body Replacement (VBR) System
- K183621 — EMMA 1.5T MRI System
- K183640 — Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes
- K183693 — Doctor Tecar
Data sourced from openFDA. This site is unofficial and independent of the FDA.