FDA 510(k) clearances — page 221
clearances on record, most recent first.
Clearances — page 221
22,001–22,100 of 175,699- 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
- K191398 — ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System
- K191535 — CoLink® Mini Plating System
- K191797 — BiomarC Fiducial Marker
- K190996 — Bonus Therapeutics Mixing and Delivery System
- K182384 — ACR LAB Urine Analysis Test System
- K182889 — KLS Martin Individual Patient Solutions (IPS) Planning System
- K183129 — Medtronic Total Hip Arthroplasty System
- K183194 — Arthrex Eclipse Shoulder Prosthesis System
- K183271 — AI-Rad Companion (Pulmonary)
- K183280 — PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs
- K183486 — RapidVit Oocyte, RapidWarm Oocyte
- K190062 — STATCLAVE G4 Chamber Autoclave
- K190533 — Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented
- K190685 — Hair Growth System
- K190873 — Infrared Ear/Forehead Thermometer
- K190949 — ScanX Barrier Envelopes
- K191328 — Megadyne Foot Switch
- K191396 — Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe
- K191714 — ASAHI Neurovascular Guide Wire CHIKAI X 014 soft
- K191733 — The ZIP Accessory Shuttle for PleuraFlow System
- K191736 — da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30
- K191777 — Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
- K191817 — ActivOrtho Continuous Compression Screw System
- K180845 — Maxima Electric System
- K182659 — Galilei G6 Lens Professional
- K183017 — Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer
- K183066 — The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD Technology-3 Fr, 4 Fr, and 5 Fr Model
- K183249 — Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage
- K190292 — Passio Pump Drainage System
- K190774 — RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant
- K190819 — Silicone PHMB Foam Wound Dressing
- K190910 — PrisMax System Version 2
- K191173 — Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires
- K191211 — JOURNEY II Unicompartmental Knee System
- K191789 — Stonetome Stone Removal Device
- K182942 — Canon OCT-A1
- K182984 — MaxiTears Contacts PF
- K190471 — 4CIS® Chiron Spinal Fixation System
- K190587 — Coolrail Linear Pen
- K190678 — TempSure
- K191100 — ExcelsiusGPS Spine 1.1 Interbody Module
- K191699 — Discovery XR656 HD with VolumeRad
- K191729 — Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System
Data sourced from openFDA. This site is unofficial and independent of the FDA.