FDA 510(k) clearances — page 227
clearances on record, most recent first.
Clearances — page 227
22,601–22,700 of 176,542- K190383 — GM501 Wash
- K190899 — bili-hut
- K190930 — SmarTemp X1
- K191004 — Advocate Non-Contact Infrared Thermometer
- K191343 — SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900
- K191625 — Persona Revision Knee System
- K191710 — FlowTriever Retrieval/Aspiration System
- K191853 — Dual-Safety Pen Needle
- K192020 — Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label
- K192119 — 3M Clarity Aligners
- K192123 — HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream
- K192148 — Freedom Primary PCK
- K183347 — K3
- K190758 — Opus Bulk Fill APS, Opus Bulk Fill Flow APS
- K190844 — Akesis Galaxy
- K191034 — VPS Impression Material
- K191070 — Signia Small Diameter Reloads
- K191179 — Myo Plus
- K191503 — MobileRay Pulse SE Digital Imaging System
- K191908 — MTS Imipenem 0.016-256 µg/mL
- K192088 — GOLNIT Non-aborbable PTFE Surgical Suture
- K192116 — Human IgA liquid reagent kit for Use on SPAPlus
- K192155 — Smith & Nephew DYONICS 25 Fluid Management System
- K192156 — Cartiva SCI instrumentation set
- K182765 — 5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial Additive Slip Tip Glass Syringe,10cc Neuraxial Slip Tip Glass Syringe,10cc Neuraxial Lock Tip Glass Syringe
- K183438 — Geomed Vascular Dilators
- K191500 — NuVasive® ACP System
- K191617 — Syntec Tibial Nail System
- K192106 — AcQRef Introducer Sheath
- K183407 — Triton Cage
- K183475 — T1-CS, T1-C
- K190449 — Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head
- K190702 — Lumipulse G whole PTH
- K190719 — Artemis Eye System
- K190810 — OPERA, OPERA eco
- K191245 — Yumizen C1200 ALP, Yumizen C1200 Albumin
- K191415 — Pathfinder Endoscope Overtube
- K191471 — Carnation Ambulatory Monitor
- K191547 — ReliefBand
- K191554 — LightWalker Laser System Family
- K191664 — SelectFlex 072 Neurovascular Access System
- K191732 — Sutter RaVoR Bipolar Electrodes
- K191786 — Cyclops Anterior Cervical Plate System
- K192058 — EV1000 Clinical Platform NI, EV1000 Clinical Platform
- K192071 — iNSitu Total Hip System
- K192074 — Signature ONE System
- K182219 — SGS Dental Implants System
- K182382 — Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink
- K182811 — gel-e Flex+
- K183489 — D2P
- K183605 — Spine & Trauma Navigation
- K190205 — HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module
- K190236 — O2Vent Optima
- K190613 — BD MAX Check-Points CPO
- K190744 — ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)
- K191159 — Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity
- K191281 — Omni Hysteroscope, Omni Lok cervical seal
- K191319 — Dunamis Fixation Button System
- K191439 — OverStitch 2-0 Polypropylene Suture
- K191475 — Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate
- K191939 — Yushan X-Ray Flat Panel Detector
- K192035 — EvaQMax Smoke Evacuation System
- K192036 — ClotTriever Thrombectomy System
- K192042 — Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal
- K192054 — Endoskeleton TAS Plate
- K192076 — Binary® Anterior Cervical Plate System
- K192107 — Clarius Ultrasound Scanner
- K192159 — Voluson E6, Voluson E8, Voluson E10
- K182142 — FEMME Applicator Tampon
- K182401 — B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology(IRT) Thermometer probe, B.O.L.T Pulse Oximeter(SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meter
- K183485 — CryoVizion System
- K190269 — PureLift
- K190437 — Delta 3300
- K190704 — Signature Ceramic Femoral Head
- K190904 — Conformis BeneFIT Hip System
- K191399 — BIOLOX CONTOURA Ceramic Femoral Head
- K191414 — EXETER Centralizer, EXETER 2.5mm Plug
- K191424 — Interphalangeal Joint Fusion Device Range
- K191533 — ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG
- K191569 — Implantcast ic-Bipolar Head System
- K191778 — Omnia Medical VBR
- K191780 — AP50/30 Insufflator with Insuflow Port
- K191810 — Curiteva Pedicle Screw System
- K191077 — Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor
- K191107 — Plexus
- K191039 — Navigated T2 STRATOSPHERE Inserters and Navigated Templates
- K191382 — IPS e.max CAD Abutment Solutions- extra systems
- K191427 — Halley resin system
- K192043 — AXIOS Stent and Electrocautery Enhanced Delivery System
- K183122 — 810nm Diode Laser System
- K182950 — Acare Suction Unit
- K183315 — CustMBite Dental Guard
- K183544 — Efficient Care 3D Planning
- K183567 — Vyntus/SentrySuite Product Line
- K183607 — FUJIFILM Bronchoscope
- K183684 — Libertas Taper Uncemented Femoral Stem
- K190127 — Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter
- K190459 — Hemoflow F3 and F4 Dialyzers
- K190593 — Zio XT ECG Monitoring System, Zio AT ECG Monitoring System
- K190813 — CrossBay Cervical Dilator Catheter System
Data sourced from openFDA. This site is unofficial and independent of the FDA.