FDA 510(k) clearances — page 229
clearances on record, most recent first.
Clearances — page 229
22,801–22,900 of 175,699- K182172 — Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora)
- K183156 — V-Laser
- K183679 — Occlusion Balloon Catheter
- K190043 — Halley resin
- K190113 — Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
- K190212 — AXS Vecta Aspiration System
- K190375 — Parcus ATLAS
- K190496 — hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
- K190789 — IntelliCartTM System
- K190812 — RAYSCAN a-Expert3D
- K181472 — AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor
- K181971 — Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set
- K182386 — Reprocessed Supreme Diagnostic Electrophysiology Catheter
- K182723 — Flexible HD Cysto-Urethroscope System
- K190110 — NanoBone SBX PUTTY, NanoBone QD
- K190489 — Elcam Stopcocks and Manifolds
- K190621 — SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long
- K190753 — EverCrossTM 0.035 OTW PTA Dilatation Catheter
- K182513 — FluChip-8G Influenza A+B Assay
- K182516 — Comprehensive Nano Stemless Shoulder
- K182778 — LC GLOSSFILL XR
- K183613 — exGraft, exGraft Carbon
- K190407 — CryoLab
- DEN180013 — PREVENA 125 and PREVENA PLUS 125 Therapy Units
- DEN180041 — Monarch eTNS System
- K180065 — FUSION Plus Curing Light
- K181571 — OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor
- K183056 — ASSURE® Anterior Cervical Plate System
- K183090 — Relieva Tract Balloon Dilation System
- K183192 — CapsoCam Plus (SV-3)
- K190415 — ATLAS Plating System
- K190463 — Cepheid Xpert C. difficile/Epi Control Panel
- K190729 — SPY Portable Handheld Imaging (SPY-PHI) System
- K190791 — Ez3D-i/E3
- K181747 — Orthodontic Appliance
- K182103 — Psychemedics Microplate EIA for Fentanyl in Hair
- K182457 — Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J
- K183593 — Lung Vision System
- K183601 — CryoTouch
- K190109 — MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL)
- K190364 — CancelleX Porous Titanium Lumbar Interbody Device
- K190506 — NeoForm Annuloplasty Ring
- K190644 — Guide Sheath
- K190788 — Disposable Standard Clamp
- K181988 — eMurmur ID
- K182702 — SEKURE Creatine Kinase Assay
- K182944 — Dr. Amplatz Micro Plug
- K182998 — Andorate Auxiliary Water Connector
- K183043 — 0.071 ID MantaRay Reperfusion Catheter, 0.055 ID MantaRay Reperfusion Catheter, 0.045 ID MantaRay Reperfusion Catheter, 0.035 ID MantaRay Reperfusion Catheter
- K183152 — Phoenix
- K183189 — Ultra OTC Facial Toning System
- K183395 — Arthrex 2.5 mm Tenodesis Screw
- K183403 — JETi 88 Peripheral Thrombectomy System
- K183584 — JO H2O Jelly Original Personal Lubricant
- K183634 — Stasis Monitoring System
- K183638 — SmartLinx Vitals Plus Patient Monitoring System
- K190082 — Straumann BLX Variobase Abutment
- K190088 — QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents
- K190369 — M-Y Sheath
- K190688 — VersaCross Steerable Sheath, VersaCross Transseptal Dilator
- K190693 — HEM-6410T-ZL Wrist Blood Pressure Monitor
- K190728 — Arthrex SwiveLock Anchors
- K181541 — Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK
- K182217 — Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use
- K182246 — MIST IC
- K182999 — General Cutting Contra Handpiece
- K183302 — KY Banksy Aloe
- K183332 — BRAXX Esophageal Brachytherapy Applicator
- K183428 — Avulsion Forceps
- K183619 — Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device
- K190773 — Elecsys TSH
- K181673 — Rigi10 Malleable Penile Prosthesis
- K181844 — One Touch
- K182272 — Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis
- K182828 — Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer
- K182924 — Diode Laser Treatment System
- K183548 — SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16
- K190072 — BriefCase
- K190320 — PreXion3D Explorer
- K190420 — NDOHD High Definition Imaging System (NDOHD)
- K190705 — WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream
- K190690 — INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir
- DEN180060 — Plenity
- K180757 — D-Clip; D-Clip Applier
- K181912 — Ascent Cardiorespiratory Diagnostic Software
- K181915 — PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
- K182396 — KardiaMobile, KardiaStation
- K182572 — InstaRISPACS / InstaZFP / InstaMobi v5.0
- K182619 — ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
- K182640 — Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue)
- K182737 — 3T 32 Channel Head Coil
- K182891 — TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants
- K183015 — PuraSinus
- K183202 — Deep Learning Image Reconstruction
- K183490 — Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface
- K183599 — Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter
- K190079 — ArgenZ HT+
- K190365 — Baby Gorilla/Gorilla Plating System
- K190626 — SyncVision System
- K190658 — MIS Bunion Plating System
Data sourced from openFDA. This site is unofficial and independent of the FDA.